MXPA01005133A - Composition comprising soy protein, dietary fibres and a phytoestrogen compound and use thereof in the prevention and/or treatment of type 2 diabetes, the metabolic syndrome and associated cardiovascular diseases - Google Patents

Abstract

A composition comprising (a) soy protein, (b) a phytoestrogen compound, and (c) dietary fibres. The soy protein (a) is present in an amount of at least 45 weight percent of the total protein content of the composition, said total protein content providing at least 15 percent of the total energy content of the composition. The phytoestrogen compound (b) is preferably a naturally occurring isoflavone and is present in an amount of more than 0.10 weight percent of the soy protein, and the dietary fibres (c) are preferably soybean fibres and are present in an amount of more than 4 weight percent of the total weight of the nutritional composition on a dry basis. The composition is useful for treating type 2 diabetes and cardiovascular diseases in a diabetic subject.

Description

COMPOSITION OF SOY PROTEIN, DIETARY FIBERS AND A COMPOSITE OF PHYTESTROGEN AND USE THEREOF IN THE PREVENTION AND / OR TREATMENT OF TYPE 2 DIABETES, METABOLIC SYNDROME AND ASSOCIATED CARDIOVASCULAR DISEASES DESCRIPTION OF THE INVENTION The present invention relates to soy protein , phytoestrogens and dietary fibers and compositions thereof suitable for preventing and treating type 2 diabetes and / or metabolic syndrome. The present invention also pertains to the use of such compositions in the prevention and / or treatment of a cardiovascular disease in a subject suing from type 2 diabetes. The compositions are particularly useful in preventing and / or reducing the influx of triglycerides and / or cholesterol in the arterial wall of diabetic subjects. The compositions are also used in the decrease of serum glucose levels and / or serum levels of cholesterol and / or triglycerides in diabetic subjects. The present invention also relates to the use of these compositions as a medicament and / or in the manufacture of a medicament for treating type 2 diabetes and / or the metabolic syndrome and / or cardiovascular disease in a subject suing from type 2 diabetes. , the present invention also provides methods for preventing and / or treating and / or treating prophylactically and / or relieving diseases and disorders by therapy. -__ iU - taíita- Serum glucose levels vary very significantly depending on the nutritional status of a subject. Following a dietary intake concentrated in carbohydrates containing glucose, several homeostatic mechanisms are able to promote glucose intake in cells as well as facilitate glucose metabolism leading for example to the synthesis of glycogen in the liver and muscles. When glucose levels subsequently drop some time after the meal, other regulatory mechanisms initiate the release of glucose from the glycogen and initiate gluconeogenesis in order to keep blood glucose levels within the required limits. Some homeostatic mechanisms are dependent on the action of hormones, and the most important hormone that promotes the ingestion of glucose and metabolism is insulin. In contrast, other hormones such as glucagon and epinephrine act antagonistically and facilitate increased levels of blood glucose. Insulin is synthesized in pancreatic β cells and secreted in response to, for example, increased levels of glucose in the blood. Once secreted into the bloodstream, insulin acts in several processes to promote i) uptake of metabolizable substrates in certain cells, ii) storage of lipids and glycogen, and iii) biosynthesis of macromolecules such as nucleic acids and proteins. More specifically, the action of insulin results in i) increased uptake of glucose in muscles and adipose tissues, ii) activation of the glycolytic pathway in the liver, iii) an increased synthesis of fatty acids and triglycerides in the liver and adipose tissues, iv) inhibition of lipolysis, v) inhibition of gluconeogenesis in liver, vi) increased synthesis of glycogen in liver and muscle tissue, vii) stimulation of amino acid uptake, viii) increased protein synthesis in muscles, and ix) inhibition of proteolysis. Elevation of blood glucose that occurs briefly after intake of a carbohydrate-rich snack stimulates insulin secretion and concomitantly suppresses glucagon secretion. The combined et is a promotion of glucose uptake in the liver, stimulation of glycogen synthesis and suppression of glycogen degradation. When blood glucose levels subsequently begin to fall, previous events are reversed. A decreased secretion of insulin and an increased secretion of glucagon leads to the breakdown of glycogen in the liver and triglycerides in adipocytes. Triglycerides are converted into fatty acids that are used by liver and muscle tissues. At the same time, decreased insulin levels serve to reduce glucose utilization by liver, muscle and adipose tissues. In type 2 diabetes, impaired insulin secretion occurs as well as decreased sensitivity to insulin.

As a result of this, glucose is present in excessive amounts in the blood stream in association with insulin whether it is low, normal or high. Type 2 diabetes accounts for approximately 80-90% of all diabetes cases and is possibly the fastest growing global issue for public health. Without reviewing the above, the current trend has been estimated to result in 215 million who will suffer from type 2 diabetes worldwide by the year 2010. Several clinical studies have implicated obesity as a risk factor for type 2 diabetes although the important mechanism for its role in The pathogenesis of the disease is still unclear. Obesity among people, who subsequently develop type 2 diabetes, as well as those with existing type 2 diabetes, is associated with increased hepatic output and reduces glucose utilization by peripheral tissues, such as for example muscles. It increases the metabolism of fatty acids in both obesity and type 2 diabetes, and this can affect the use of glucose by interfering with the actions of insulin. The development of type 2 diabetes is progressive and probably to be a culmination of pathophysiological changes that occur for many years. In most cases, the subject is not aware of the disease process, particularly in the early stages. The first stage of the disease is thought to be initiated due to insulin resistance. Insulin resistance is strongly associated with, and probably a major contributor to, the disease that eventually enters the diabetic state. The stage of insulin resistance is characterized by reduced sensitivity to insulin, just as cells normally stimulated by insulin are less sensitive to the hormone. The next stage of the disease is that of impaired tolerance to glucose (TDG). TDG follows a continuous increase in insulin resistance, that is, a continuous decrease in insulin sensitivity. Impaired tolerance to glucose is formally defined as a concentration of glucose in sensitive venous plasma < 7.0 mmol / L (126 mg / dl) and a venous plasma value of two hours after uptake of 75 grams of oral glucose 7.8 (> 140) and < 11.1 mmol / 1 (< 200 mg / dl). When the glucose concentration is 11.1 mmol / l, that is, an indicator level of type 2 diabetes, the risk of developing specific diabetic complications is quite increased. However, TDG and type 2 diabetes are both associated with a 2-4-fold increase in the burden of cardiovascular disease. The glycemic criteria of the World Health Organization (WHO) have been applied in a number of TDG studies. These studies have determined the progression rate for type 2 - 5 \ 10 years after the detection of TDG - between 19% and 61%. The final stage of development of type 2 diabetes is characterized by failure of insulin secretion (FSI). In this stage of type 2 diabetes, the secretory response of insulin is inadequate. It is believed that this results from damage of the pancreatic β-cell functions and / or the inability of the β-cells to secrete sufficient amounts of insulin to compensate for the increased insulin resistance. It is understood that all of the aforementioned phases in the development of type 2 diabetes that lead to manifest diabetes will be considered to be encompassed by the term type 2 diabetes as used herein. Accordingly, it will be understood that a diagnosis of impaired glucose tolerance and / or reduced insulin sensitivity are related to an individual also diagnosed as suffering from type 2 diabetes, or a condition, including any precondition, leading to type 2 diabetes The progression of normal glucose tolerance (TGN) to impaired glucose tolerance (TDG) is characterized by i) increased insulin resistance or decreased sensitivity to insulin and ii) gradual increases in both sensitive and stimulated plasma insulin levels for glucose. As soon as TDG progresses gradually to medium sensitive hyperglycemia, there may be a small additional increase in insulin resistance in both glucose-stimulated and sensitive insulin release. However, in this situation, additional increases in the proportion are no longer sustained and manifest sensitive hyperglycemia and increased post-load glucose intolerance begin to emerge. Many cardiovascular risk factors are abnormally high in individuals suffering from type 2 diabetes and are consequently an increased risk to develop various arteriosclerotic vascular diseases. At the time of diagnosis of type 2 diabetes, the existence of arteriosclerotic manifestations is already pronounced in many individuals and may include hyperlipidemia, hypercholesterolemia, hypertriglyceridectomy, hyperglycemia, hypertension and hyperinsulinemia. Arteriosclerosis is a common term for a group of conditions related to the arterial system that leads to an increased arterial wall thickness and a subsequent loss of elasticity. Three major groups of arteriosclerosis that are frequently referred to are atherosclerosis, Monc eberg's halfclerosis, and arteriolosclerosis. Atherosclerosis is observed more frequently in the aorta and in the main arteries connected to it, in the coronary arteries and in the arteries of the brain. Monckeberg's mediaclerosis leads to a narrowing of the middle of the arteries of the extremities, and arteriolosclerosis is related to a narrowing of the small arteries and arterioles caused mainly by hypertension. An arterial condition that commonly occurs in diabetics is that of atherosclerotic cardiovascular disease. The condition can progress eventually through several stages. A normal structure of an artery is characterized by discrete focal numbers of adhesion monocytes, some intimate foam cells, and some intimate uniform muscle cells or intimal cell masses in. bifurcations. A fat groove may occur non-symptomatically and involve a layer of foam cells. As soon as arteriosclerosis progresses, the cells that make up the inner wall of an artery will gradually begin to harden due to plaque deposition and the cells may eventually become degenerated. As soon as the wall of an artery thickens, hardens and loses its elasticity during arteriosclerosis, the blood vessel channels can develop coils and changes and become constricted in such a way that the heart must work harder to pump the usual amount of blood. blood through the arteries. The condition may return or may evolve into formation of eg fibrous plaque. The fibrous plaque is a slowly reversible condition that can evolve to become a complicated lesion. The cellular degeneration will most likely result in a fracture of the arterial wall which in turn leads to calcium deposition, platelet formation and a gradual development of scar tissue in addition to contributing to both cell degeneration and a substantially reduced elasticity of the arterial wall. Atherosclerosis characterized by a restricted flow of blood through a coronary artery can lead to the development of coronary heart disease. A complicated artery injury is often symptomatic, harshly reversible and can, in some cases such as thrombosis, be lethal. If a blood clot forms in a coronary artery, interruption of blood flow can result in the death of the part of the heart muscle and cause the extremely painful chest pains associated with the heart attack. Accordingly, although it is well established that cholesterol, lipids and lipoproteins all contribute to the progression of various arteriosclerotic conditions in individuals suffering from diabetes, is little known about the causes of arteriosclerosis. So far there is no simple cure or medical treatment for arteriosclerosis and no effective preventive therapy to treat diabetics suffering from the symptoms of cardiosecular diseases. The effect of arteriosclerosis development in diabetes is very clear. The proportion of total deaths from coronary heart disease (CHD) in diabetes has progressively increased and is now reported to cause almost 75 percent of all deaths among type 2 diabetics. However, despite the association between diabetes, Insulin resistance, blood lipids, hypertension and premature arteriosclerosis has been well recognized, the complex mechanisms responsible for this association are still vegy and evasive as they were more than 50 years ago. For type 2 diabetes, a medical discovery has not currently occurred since i) that insulin was discovered in 1922 and from ii) that sulfonylureas, biguanides, and α-glucosidase inhibitors were developed in 1954, 1957, and 1986, respectively. Obesity and insufficient physical exercise have been suggested to be major contributors to type 2 diabetes and coronary heart disease and heart infarction are among the most common cardiovascular conditions diagnosed in diabetic subjects. It has been estimated that two out of three diabetics contract cardiovascular disease. An increased level of serum triglycerides is a prominent risk factor for cardiovascular diseases in a diabetic subject. Importantly, recent studies have indicated that serum triglyceride levels considered concurrently as "normal" - (2.2 mmol / 1) or 200 mg per deciliter of serum - may indeed be very high. It has been proposed that the "normal" limit for triglycerides should be reduced by as much as 50 percent compared to the limit currently considered to be the "normal" limit (Yahoo New, May 1, 1998). In a group of patients over almost 20 years, a serum triglyceride level of more than 1.1 mmol / l or 100 mg per deciliter of serum currently increases the relative risk of contracting a new cardiovascular event by 50 percent and reduces the chance to survive that event. It is emphasized that until now clinical trials have not examined whether the decrease in triglyceride levels affects the incidence of subsequent cardiovascular events, and research into the effect of serum triglyceride levels on cardiovascular events lag research aimed at establishing the effect of Increased levels of serum cholesterol in the subsequent development of cardiovascular diseases. Adlercreutz (Finnish Medical Society, Ann. Med. 29, 95-120 (1997)) emphasizes that definitive recommendations can not be made regarding the dietary amounts of soy isoflavones necessary for disease prevention. It is emphasized that phytoestrogens, particularly in association with soy intake, seem to have a great potential to prevent cardiovascular diseases, but as the area is actually in stages Early development, an established beneficial effect of soy and isoflavonoids in this regard will have to await additional studies. It is further established that despite abundant literature in this early stage of dietary phytoestrogen research, much work is necessary before that some recommendation can be made regarding phytoestrogen consumption. However, the experimental and epidemiological evidence does not support the observation that these compounds have no negative effect and that they can form a group of substances with great potential in preventive medicine. It is emphasized that up to now no definitive recommendations can be made regarding dietary amounts necessary for the prevention of diseases. No reference is made to a composition comprising a combination of soy protein, a content high of a phytoestrogen compound, and dietary fibers.

^ W? THi ^ Anderson (N. Eng. J. Med. 333, 276-282 (1995) analyzes a total of 38 clinical trials and concludes that consumption of soy protein significantly lowers cholesterol, LDL-cholesterol and total triglycerides in serum It was found that the ingestion of diets containing soy protein, compared to control diets, is accompanied by a significant reduction in cholesterol, LDL-cholesterol and total triglycerides in serum concentrations. Soy protein does not significantly affect serum concentrations of I ^ LD-cholesterol.Some types of soy proteins, such as isolated soy protein, textured soy protein, or a combination thereof, are studied and Soy protein type does not have any significant effect on the net change in serum cholesterol levels.The study does not consider a simultaneous uptake of the various types of soy proteins. with dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. Hendrich (J. Nutr. 124 (9 Suppl.) Has reported that isoflavones may be of great beneficial potential for maintaining human health and that isoflavones may be protective of health in potentially available quantities of a human diet containing soy foods. The food content of isoflavones is in the range of 0.1 to 1 mg / g in soy foods, and various factors such as variety of soybeans, processing and the addition of other ingredients to the food, influence the isoflavone contents of the It is established that human intestinal bacteria can destroy the ingested isoflavones at a large extension and that this may be because only 15 to 20 percent of the isoflavones are recovered intact from the urine and feces. emphasizes that a lot of work remains to determine the relationship between the concentration of isoflavones in urine and human plasma and the biological effects of the isoflavones. It is noted that although more health-related animal data needed to be obtained, the time is approximated when long-term human feeding trials of purified isoflavones and foods containing isoflavones to examine health-related solutions can be guaranteed. No reference is made to a composition comprising a combination of soy protein, a high content of phytoestrogen compound and dietary fibers. Knight (Maturitas 22, 167-175 (1995)) provides a synopsis of the literature mainly related to the clinical effects of phytoestrogens in diseases associated with age. A literature review that --- "•" • - belongs to cardiovascular diseases states that the protective effects of phytoestrogens are manifested through changes in lipids, a decrease in LDL-cholesterol and an increase in HDL-cholesterol and vascular effects, with which they are related To the vasomotor tone and spleen wall compliance, the consumption of soy protein is reported to alter lipid levels and the dietary soy protein appears to be anti atherogenic when compared to several animal proteins. represents a large and exciting group of compounds with potential benefits for many diseases in diabetes. It is emphasized that current evidence justifies the conclusion that phytoestrogens may be among the dietary factors that produce protective effects against heart disease. heart However, additional clinical studies are required to elucidate its effects more clearly. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. 20 Knight (Obstet, Gynecol. 87, 897-904 (1996)) has reviewed the sources, metabolism, potencies and clinical effects of phytoestrogens in humans. The review suggests that phytoestrogens are among the dietary factors that produce protection against heart disease in vegetarians. Based on epidemiological studies and lines - Cellular, it is emphasized that intervention studies are now an appropriate consideration for evaluating the clinical effects of phytoestrogens because of the potentially important health benefits associated with the consumption of foods containing these compounds. It is concluded that the clinical applications for phytoestrogens are still in their infancy. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. Packard (Arterioscler, Thromb. Vasc. Biol. 17, 3542-3556 (1997)) has reviewed heterogeneity in lipoprotein classes containing apoB and provides an interpretation of kinetic studies of apoB metabolism in light of structural and functional variations important The review is based on the fact that the lipoprotein classes are composed of a limited number of components with different properties. However, the basis for this heterogeneity and the consequences for disease are not fully understood. The LDL fraction is made up of a small number of subtypes of particles with relatively discrete size and density. Subjects with a preponderance of small-sized LDL have a three-fold increased risk of myocardial infarction regardless of the total LDL concentration present.

No reference is made to a composition comprising a combination of soy protein, a high content of phytoestrogen compound, and dietary fibers. Potter (Am. J. Clin. Nutr. 58, 501-506 (1993)) studied the effects of soy protein consumption with and without soy fiber on plasma lipids in mildly hypercholesterolemic men. It is reported that LDL-cholesterol and total concentrations can be significantly decreased in mildly hypercholesterolemic men, as indicated by a 50% replacement of dietary protein with soy protein. Similar reductions in blood lipids are indicated for isolated soy protein, whether consumed together with soybean cotyledon fiber or cellulose fiber. Plasma triglyceride concentrations are not affected by the various dietary treatments described in the article. The study reveals no effect of cholesterol reduction of the concurrent uptake additive of soybean cotyledon fiber with isolated soy protein, and it is established that it is unknown whether there is an added benefit in the reduction of blood cholesterol concentrations of Increased concurrent uptake of soy protein and fiber in humans. No reference is made to a composition comprising a combination of soy protein, a high content of phytoestrogen compound, and dietary fibers.

Reinli (Nutr. Cancer 26, 123-148 (1996)) has reviewed the literature for quantitative data on the levels of known phytoestrogens (daidzein, genistein, coumestrol, formononetin and biochanin A) in food plants. It is reported that daidzein and genistein isoflavones can exist in four related chemical structures, that is, an aglycone structure (daidzein and genistein), a 7-0-glucoside structure (daidzin and genistin), a 6'-O-acetylglucoside structure (6"-0- 10 acetyldaidzin and 6 '-O-acetylgenistin) and a 6'-0-malonylgucoside structure (6'-O-malonyldaidzin and 6'-O-malonylgenistin) The conjugates (7-O-glucosides, 6'-O-acetylglucosides, and 6'- O-malonylglucosides) are transformed into aglycones, which are sometimes called free isoflavones, through the hydrolysis in the intestinal tract by ß-glucosidases enzymes of intestinal bacteria. Acid hydrolysis in the stomach may also contribute to the formation of free isoflavones. It is not clear how the conjugates easily undergo intestinal hydrolysis and subsequent absorption. Indicates that isoflavones are metabolized differently by different animals and humans. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. 25 Sniderman (Am. J. Cardiol. 79, 64-67 (1997)) J * "1 -'- •" * presents a risk factor hypothesis with an emphasis on the integral role of LDL in atherogenesis. It is emphasized that a measurement of LDL-cholesterol is an incomplete estimate of the risk attributable to LDL and that other classic risk factors such as hypertension, diabetes and smoking exert their proatherogenic potential quite or exclusively by multiplying the malignant influences of LDL in the arterial wall. It is known that small, dense LDL particles are one of the most common dyslipoproteinemia associated with coronary artery disease. It is reported that elevated levels of lipoprotein (a) are associated with increased coronary risk, but the basis for this is still unclear. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. WO 95/10512 relates to a process for producing an aglucone isoflavone enriched with plant protein whey and describes in a modality a serum having a dry base genistein content of from about 2.6 to about 8.7 mg / gram and daidzein content in dry base from about 2.5 to about 6.0 mg / gram. There is no reference to a treatment of diabetes when using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. WO 95/10529 relates to a process for producing an aglucone isoflavone enriched with protein concentrate and describes in one embodiment a concentrate having on a dry base a genistein content of about 1.0 to about 2.0 mg / gram and a daidzein content. from about 0.7 to about 1.5 mg / gram. NQ refers to a treatment of diabetes by using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. WO 95/10539 relates to a process for producing an aqueous extract comprising protein and isoflavones glucone and describes in a modality an isolate of vegetable protein having a content of genistein in dry base of about 1.5 to about 3.5 mg / gram and a content of daidzein in dry base of about 1.0 to about 3.0 mg / gram. There is no reference to a treatment of diabetes when using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. WO 97/31546 describes data on total replacement programs (for 6 weeks) in weight reduction studies conducted at Karolinska Hospital in Switzerland. It is shown that products comprising isolated soy protein and soybean cotyledon fibers reduce serum cholesterol levels by a maximum of 27 percent and triglyceride levels by a maximum of 44 percent for a patient population with an average initial cholesterol content of 5.6 mmol / 1. A mean value of 6.25 mmol / l is determined for all patients who have serum cholesterol levels above 6 mmol / l, and for this group of patients a reduction in serum cholesterol levels of 33 percent is observed. Since the reported data are part of a weight reduction program, a dietary effect and / or an effect related to weight loss may have contributed to the observed reductions in cholesterol and / or triglycerides. There is no reference to a treatment of diabetes using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. WO 97/37547 describes a soy protein product enriched with isoflavone having a protein content greater than 60 percent of the total dry matter, a total dietary fiber content of less than 4 percent of the total dry matter, a sucrose content greater than 10 percent of the total dry matter, total content of sulfur-containing amino acids greater than 2.2 percent of the total amino acid content, a stachyose content of less than 1.5 percent by weight of total dry matter, and a total isoflavone content greater than 2.5 mg / gram, equivalent to 0.25 percent. The use of soybean cotyledon fibers is not anticipated and the claimed invention is for use as an ingredient in the production of an edible product and not in a diabetes treatment. Also, the product differs from the present invention by comprising total dietary fiber in an amount of less than 4 percent total dry matter, and by containing an unusually low amount of stachyose and a large amount of sulfur-containing amino acids. No reference is made to a treatment of diabetes by using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a large content, a phytoestrogen compound and dietary fibers. U.S. Patent 5,320,949 describes a process for producing a fiber product enriched with isoflavone aglucone from a vegetable protein material in the form of a coarse slurry and describes in one embodiment a fiber product enriched with aglucone obtainable directly from the process and which has a genistein content of about 1.0 and 2.0 mg / gram and a content of about daidzein of about 0.7 to 1.7 mg / gram. No reference is made to a treatment of diabetes by using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. U.S. Patent 5,352,384 describes a fiber product enriched with aglucone having a genistein content of about 1.0 to 2.0 mg / gram and a daidzein content of about 0.7 to 1.7 mg / gram. No reference is made to a treatment of diabetes by using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. European Patents EP 827 698 A2 and EP 827 698 A3 describe a process for producing an extract enriched with isoflavone aglucone from a plant material containing isoflavone and protein conjugates. No reference is made to a treatment of diabetes by using a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. A summary presented at the 38th annual conference of the American Heart Association on Cardiovascular Disease Epidemiology and Prevention held in March 1998 describes a reduction in LDL-cholesterol and total levels in a subject after ingestion of a diet supplemented with 25 grams of protein of soybean containing 4 mg, 25 mg, 42 mg and 58 mg of isoflavones, respectively. A "dose response" effect is reported in such a way that increased amounts of isoflavones are associated with an increased cholesterol reduction. A maximum reduction of LDL-cholesterol serum levels and total of 4 percent and 7 percent, respectively, is reported for the product containing 58 mg of isoflavone. There is no reference to a treatment of diabetes when using a composition comprising a combination of soy protein, a high content of phytoestrogen compound and dietary fibers. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound and dietary fibers. The present invention provides a nutritional composition having a fixed, high amount of a phytoestrogen compound such as, for example, naturally occurring isoflavones. More particularly, the present invention provides a nutritional composition of extractable soybean ingredients having a fixed, high amount of a phytoestrogen compound such as, for example, naturally occurring isoflavones. The present invention represents a potential new advance in diabetes treatment and more particularly, the present invention provides a combination comprising a) soy protein, preferably isolated soy protein, b) a fixed high content of a plant hormone in the form of a phytoestrogen compound, preferably naturally occurring isoflavones; and c) dietary fibers, preferably soybean fibers, more preferably soybean fibers made from the cotyledon of soybeans referred to hereinbelow as cotyledon fibers of soy. The present invention is useful in the prevention and / or treatment of type 2 diabetes and / or cardiovascular disease in diabetic subjects. Accordingly, a composition according to the present invention is effective in decreasing the serum levels of both glucose and cholesterol and / or triglycerides. No treatment is currently available to concomitantly decrease serum glucose levels as well as serum levels of total cholesterol and LDL-cholesterol and / or triglycerides. It is well understood that diabetic subjects according to the present invention have glucose in sensitive plasma > 7.0 mmol / 1. A composition according to the present invention represents a new method for treating type 2 diabetes and is believed to be capable of i) lowering serum glucose levels, ii) lowering serum levels of insulin, iii) lowering total cholesterol levels and LDL-cholesterol and / or serum triglycerides, iv) increase glucose tolerance and / or insulin sensitivity and / or vi) avoid and / or alleviate and / or treat impaired glucose tolerance and / or insulin secretory failure in subjects diabetics and / or vi) avoid and / or alleviate and / or treat an arteriosclerotic condition by reducing the influx of cholesterol and / or triglycerides in the endothelium of the arterial wall of a diabetic subject suffering from cardiovascular disease. No other different composition is effective in decreasing serum levels of both lipids and glucose and / or reducing the influx of lipids such as for example cholesterol and / or triglycerides in the arterial wall. A composition according to the present invention can be comprised in a micronutrient as defined hereinafter. The phytoestrogen compounds are naturally occurring plant hormones that show a structural similarity to 17β-estradiol. Phytoestrogens consist of a number of classes including isoflavones, coumestans, lignans and lactones resorcílico acid. The isoflavone class consists of genistein, daidzein, equol, glycitein, biochanin A, formononetin and 0-demethylangolesin, among others. The isoflavones genistein and daidzein are found almost exclusively in soybeans. When they are present in the plant the isoflavones are mainly in the form of a glucoside, that is, bound to a sugar molecule. The isoflavones in this form of glucoside can be deconjugated to produce isoflavones in a form so called aglycone, which is the biologically most active form of isoflavones and which are absorbed faster and to a greater degree in the human intestine than isoflavones in the form of glucoside. The in vitro studies have examined the relative estrogenic effect exerted by several phytoestrogens that include isoflavones. The resulting potencies compared to estradiol (which have a relative potency of 100) have been reported by Knight (Maturitas 22, 167-175 (1995)) for among others genistein (0.084) and daidzein (0.013). However, the results also show that the estrogen receptor complexes formed by estradiol and isoflavones such as genistein and daidzein are functionally equivalent. The comparative dissociation constant of genistein for the estrogen receptor, as determined in competitive binding assays, is found to be 100 to 10,000 times greater than that of estradiol. The term "naturally occurring" substance as used in the present specification and the appended claims refers to a substance originally isolated from a natural source, such as an animal or a plant, for example a soybean plant, or modified forms of such substance. The naturally occurring substance for use in a composition according to the present invention can be included in a composition according to the present invention as part of the natural source or in any type of extract, isolate or the like thereof, or it may have been isolated from a plant source or synthesized biologically, microbiologically or chemically by any other means. Soy proteins are involved in a decrease in cholesterol and triglyceride levels, they are easily digestible, and represent a single efficient protein source to maintain nitrogen balance. Soy isoflavones in high intakes also improves this effect. Dietary fibers, such as soybean fibers, especially soybean cotyledon fibers have been shown to decrease serum total cholesterol levels, to improve glucose tolerance, to increase insulin sensitivity, to normalize gastrointestinal function , and not to influence the absorption of essential minerals. Accordingly, in one aspect the present invention provides a composition comprising (a) a source of soy protein, selected from isolated soy protein, soy protein concentrate, or soybean meal, the source of soy protein providing a amount of soy protein, which is at least 45 weight percent of the total protein content of the composition, the total protein content that provides at least 15 percent of the total energy content of the composition, (b) at least one phytoestrogen compound in an amount of more than 0.16 weight percent of the total protein content of the composition, and (c) dietary fibers in an amount of more than 6 weight percent of the total weight of the composition on a dry basis. In a more preferred aspect the present invention provides a composition comprising (a) isolated soy protein in an amount of at least 50 percent by weight of the total protein content of the composition, the total protein content it provides at minus 15 percent of the total energy content of the composition, (b) at least one phytoestrogen compound in an amount of more than 0.16 weight percent of the soy protein content of the composition, and (c) soybean fibers in an amount of more than 6 percent by weight of the total weight of the composition on a dry basis. In a more preferred aspect the present invention provides a composition comprising (a) isolated soy protein in an amount of at least 50 percent by weight of the total protein content of the composition, the total protein content it provides at minus 15 percent of the total energy content of the composition, (b) at least one phytoestrogen compound in an amount of more than 0.16 weight percent of the soy protein content of the composition, and (c) cotyledon fibers of soy in an amount of more than 6 weight percent of the total weight of the composition on a dry basis. The phytoestrogen compounds are naturally occurring plant substances, which are either structurally or functionally similar to 17β-estradiol or generate estrogenic effects. Phytoestrogens consist of a number of classes that include isoflavones, coumestan, lignan, and resorcinic acid lactones. Examples of isoflavones according to the present invention are genistein, daidzein, equol, glycitein, biochanin A, formononetin and O-des ethylangolesin. The phytoestrogen compounds of a composition according to the present invention are preferably isoflavones, more preferably genistein, daidzein, glycitein and / or equol, even more preferably genistein and / or daidzein and even more preferably genestein. Genistein and daidzein are found almost exclusively in soybeans. A preferred composition according to the present invention may therefore comprise a single isoflavone, such as genistein, daidzein, glycitein or equol, or may comprise at least one isoflavone selected from the group consisting of at least genistein, daidzein, glycitein and equol. A composition according to the present invention can be effective in treating and / or avoiding type 2 diabetes and / or the metabolic syndrome and / or reducing and / or eliminating one or more of the risk factors for cardiovascular diseases associated with diabetes and / or or the metabolic syndrome. Accordingly, a composition according to the present invention can be effective in preventing, alleviating and / or treating conditions such as, for example, increased serum glucose levels, hypertriglyceridemia, hypercholesterolemia, hypertension, and hyperinsulinemia in diabetic individuals. A composition according to the present invention may also be capable of reducing, preventing and / or eliminating fatty furrow formation and / or fibrous plaque development and / or effective in mediating a regression of one or both arteriosclerotic conditions. A composition according to the present invention can be effective in reducing insulin resistance by stimulating cells or receptors located therein that are normally stimulated by insulin, but less sensitive to the hormone in a subject diagnosed with type 2 diabetes and / or the metabolic syndrome. A composition according to the present invention can also be effective in stimulating cells comprising a beta-2-adrenergic receptor or a receptor belonging to the class of beta-2-adrenergic receptors. The final stage of development of type 2 diabetes is characterized by insulin secretory failure (FSI), and in a currently preferred hypothesis, this failure is at least avoidable by a composition according to the present invention effective to stimulate insulin secretion. Both plasma triglyceride and lipoprotein levels are usually increased in individuals treated for type 2 diabetes and / or the metabolic syndrome, and these increased levels, unless reduced by treatment, are likely to lead to coronary heart disease (CHD). Beta-2-adrenergic receptors are present in many different types of cells including fat cells. The beta-2-adrenergic receptor is involved in the regulation of triglyceride synthesis in fat cells and according to a currently preferred hypothesis, the binding of soy peptides and / or a phytoestrogen compound such as for example an isoflavone that is naturally found to a beta-2-adrenergic receptor present in a fat cell or in an arterial wall is effective in reducing eg the synthesis of triglycerides in fat cells and / or the release of triglycerides in the bloodstream and / or reduce the influx of triglycerides in the arterial wall. Soy peptides are for example obtainable as a partial hydrolyzate of soy protein. Hypertriglyceridemia in diabetes has been associated with a variety of changes in circulating lipoproteins, and a composition according to the present invention may be able to avoid, treat, alleviate and / or eliminate cardiovascular risk factors such as for example chylomicronemia, a level increased VLDL, an increased level of remnants (VLDL and chylomicrons), and LDL and HDL containing increased levels of triglycerides. The lipoprotein fractions obtained from type 2 diabetic subjects tend to lose their typical acute LDL peak and instead have a broad diffuse LDL band named polydispersed LDL. Dissection of polydispersed LDL reveals that diabetics have an increased level of intermediate density lipoprotein serum, an abnormal LDL peak, and an increase in the amount of small dense LDL. While small dense LDL particles have been associated with CHD in the general population, a similar association in diabetes remains to be established. Accordingly, a composition according to the present invention can be effective in promoting a lowered level of intermediate density lipoprotein (IDL) serum, an acute, normal LDL peak, and a decreased amount of small dense LDL. Accordingly, diabetic dyslipidemia of type 2 diabetes is generally associated with abnormalities of apolipoprotein and lipoprotein particle distributions and results in increased plasma VLDL and retentive levels, an increase in the amount of small dense LDL, and an HDL particle distribution. altered According to a currently preferred hypothesis, a composition according to the present invention will alleviate abnormalities associated with apolipoprotein and lipoprotein particle distribution and will promote decreased plasma VLDL and a retentive level, a decrease in apoE concentration in VLDL and remnants, a decrease in the amount of small dense LDL, and an HDL particle distribution similar to that of a comparable healthy, non-diabetic individual. Hypertriglyceridemia in diabetes is associated with an increase in clotting activities of thrombogenic factors such as factor VII and factor X and an increase in the level of the plasminogen activator inhibitor in tissue, PAI-1. The increased concentration of the inhibitor results in a decreased level of plasminogen synthesis and thus a decreased level of plasminogen stimulates clot lysis. These changes in coagulation activities undoubtedly contribute to the procoagulant state observed in diabetes. Accordingly, the present invention provides a composition, which may be effective in normalizing the coagulation activities of thrombogenic factors such as factor VII and factor X by, for example, decreasing the increased activity thereof observed in a subject diagnosed as has type 2 diabetes or is diagnosed as having impaired glucose tolerance or decreased sensitivity to insulin. Also, a composition according to the present invention can be effective in promoting a decrease in the concentration of the plasminogen activator inhibitor in tissue, PAI-1, which in turn leads to an increased plasminogen-stimulated clot lysis. A composition according to the present invention can also be effective in reducing a capacity of increased platelet aggregation and / or directly or indirectly mediating a reduction in the increased level of lipoprotein (a) associated with a procoagulant state in a diabetic condition. Hyperinsulinemia is also considered a risk factor for coronary heart disease (CHD) in diabetic subjects due to the association of high insulin levels with increased incidence and death rates of CHD. A composition according to the present invention may be effective in decreasing serum insulin levels in subjects diagnosed with type 2 diabetes. Diabetic patients having increased levels of endogenous insulin, ie diagnosed with type 2 diabetes, or having increased levels of peripheral circulating insulin as a result of intermittent injections of large amounts of exogenous insulin are particularly prone to hyperinsulinemia. Hyperinsulinemia in both normal people, people with metabolic syndrome and those with type 2 diabetes seems to be related to obesity. Insulin levels are often greatly increased in both the sensitive state and after ingestion of a carbohydrate-rich diet in obese individuals, regardless of whether they suffer from a diabetic condition or not. Additionally, hyperinsulinemia seems to correlate directly with the degree of obesity. Consequently, hyperinsulinemia is one of the many risk factors for CHD associated with obesity, and insulin can modulate many other risk factors related to obesity. Accordingly, a composition according to the present invention can be effective in decreasing insulin levels in obese subjects with diabetes or metabolic syndrome. In obese subjects diagnosed as diabetics, the LDL particle size is correlated independently with factors such as for example serum triglyceride levels and serum insulin. Consequently, it is possible that the degree of adiposity and concomitant insulin resistance in hyperinsulinemic individuals is associated with the occurrence of small dense LDL, independently of hypertriglyceridemia, which is another diabetic condition also putatively associated with small dense LDL formation. Therefore, both ainsulin resistance and hyperinsulinemia seem to play a central role in the pathogenesis of atherosclerosis in diabetes. A composition according to the present invention can be effective in alleviating and / or treating ainsulin resistance and / or hyperinsulinemia. In one embodiment, the present invention provides a composition effective in reducing and / or eliminating risk factors for coronary heart disease (CHD) in obese subjects suffering from a diabetic condition and / or metabolic syndrome. Accordingly, a composition according to the present invention may be able to prevent, alleviate, treat and / or eliminate hyperinsulinemia and / or hyperglycemia and / or hypertension and / or hypertriglyceridemia and / or hypercholesterolemia and / or effective in mediating an increase in low serum levels of HDL-cholesterol. It is quite possible that type 2 diabetes is also associated with insulin resistance and hyperinsulinemia regardless of an increase in abdominal lipids. Hyperinsulinemia in turn is associated with dyslipidemia, ie increased VLDL, decreased and altered HDL and increased small dense LDL, and with hypertension, all of which are risk factors for atherosclerosis. This arrangement of abnormalities and disorders, or a portion thereof, is generally referred to as insulin resistance syndrome, or syndrome X or metabolic syndrome. Although there is no internationally agreed definition for the metabolic syndrome, the term as used herein must be understood to relate to the occurrence in a subject of at least one of the following: i) impaired glucose tolerance , ii) high blood pressure, iii) hypertriglyceridemia and low HDL-cholesterol, iv) insulin resistance, and v) obesity. The occurrence of a condition characterized by one or more impaired glucose tolerance, high blood pressure, hypertriglyceridemia and low HDL-cholesterol, insulin resistance, and obesity will depend on variables such as sex, age, body weight, physical condition and similar, and general WHO guidelines will generally adhere to when to assess the occurrence of any of the conditions listed above. In one embodiment, a composition according to the present invention may be capable of effectively decreasing and / or eliminating increased serum levels of VLDL and / or LDL., and / or increasing decreased serum levels of HDL, and decreasing and / or eliminating LDL serum levels including serum levels of dense, small LDL. A composition according to the present invention may also be able to reduce a high level of dense, small LDL particles and / or reduce a high proportion of LDL-apB to LDL-cholesterol and / or prevent, treat or relieve hypertension. Hyperinsulinemia itself can be good capable of affecting the arterial wall either directly or indirectly by promoting or facilitating the promotion of changes similar to those that lead to severe atherogenesis. Insulin may well promote both arterial smooth muscle cell proliferation and ester accumulation cholesterol in the arterial wall. A composition according to the present invention may in one embodiment be effective in preventing, alleviating, eliminating and / or treating fatty sulcus formation, fibrous plaque development, complicated injury formation, thrombosis, platelet aggregation and / or infarction to the myocardium. A composition according to the present invention may also be capable of suppressing any effect, which may otherwise generate an increased change of arterial smooth muscle cells, i.e., a smooth muscle cell proliferation arterial increased, and / or lead to an accumulation of ester ^? Oit ttf.

Increased cholesterol in the arterial wall. Since insulin may be expected to be capable, either in combination with other compounds such as additional growth factors, or in itself, of increasing intracellular cholesterol levels, for example by increasing a supply of LDL-cholesterol via the LDL receptor, and concomitantly with the same increase an endogenous cholesterol biosynthesis that makes cholesterol even more available for new membrane synthesis in the cell proliferation process, is an object of the present invention against attacking any increased activity including any increased activity stimulated by LDL receptor insulin. It is also possible that insulin and other growth factors have the potential to promote cholesterol accumulation intracellularly. This can in fact occur well in a diabetic subject and more generally under conditions when the cells are stimulated, but can not proliferate normally. Accordingly, a composition of the present invention may also be able to alleviate, eliminate and / or treat any decrease, including insulin-mediated decrease, in the flow of HDL-receptor-mediated cholesterol. Accordingly, a composition according to the present invention can be capable of reducing and / or eliminating any increased retention of intracellular cholesterol caused by a decrease in cholesterol flow mediated by the HDL receptor. Modifications to lipoproteins are another risk factor for cardiovascular disease in diabetes. The modification characterized by protein glycosylation is associated with diabetes, and glycosylated lipoproteins such as for example LDL, IDL, VLDL and HDL can be expected to be functionally abnormal. Accordingly, the accumulation of glycosylated LDL in the plasma of a diabetic subject can be perceived to increase the cholesterol ester accumulation. Also the glycosylation of HDL can be expected to damage the ability of HDL to bind to the HDL receptor. This damaged link is likely to reduce the level of intracellular cholesterol flow. Therefore, glycosylated HDL may well be another factor that potentially contributes to the accumulation of cholesterol in the arterial cell wall. A composition according to the present invention can be effective in preventing, alleviating, treating, reducing and / or eliminating glycosylation of lipoprotein in a diabetic subject. In addition, a composition according to the present invention can also be effective in preventing lipoprotein modification caused for example by oxidation, chemical modification such as chemical cross-linking, or modifications caused by an alteration in & > the lipid composition of lipoprotein, such as any increase or decrease in the content of triglycerides, cholesterol esters, free cholesterol, and apolipoproteins. Glycosylated lipoproteins have been suggested to be the subject of further processing leading to the formation of hyperglycosylated compounds. The glycosylation and hyperglycosylation of proteins including lipoproteins in both plasma and arterial wall may also be expected to be a risk factor for cardiovascular disease including arteriosclerosis in diabetic subjects. Therefore, a composition according to the present invention may be able to prevent, treat, reduce, alleviate and / or eliminate the accumulation of hyperglycosylated proteins in both serum and arterial wall cells. By doing this, the composition is acting to decrease the amount of LDL that leads to being "trapped" in the arterial wall due to the high degree of glycosylation of artery wall proteins. A composition according to the present invention may also be effective in alleviating and / or preventing any change in the endothelial cell wall that increases the "entrapment" of LDL, and this may be effective in restoring the formation of cells with normal permeability and parameters. of adhesion. The glycosylation of lipoproteins, hyperglycosylation, oxidation and / or auto oxidative glycosylation, are risk factors for cardiovascular disease such as arteriosclerosis in diabetes. Accordingly, a composition according to the present invention can be effective in eliminating, preventing, alleviating, treating and / or reducing any incidence of lipoprotein glycosylation, hyperglycosylation, oxidation and / or auto oxidative glycosylation. According to a currently preferred hypothesis, the phytoestrogen compound of a composition according to the present invention is capable of contracting incidences. The phytoestrogen compound may also be able to prevent, reduce and / or eliminate the formation of for example free radicals that are likely to be involved in such processes, and a composition according to the present invention may be effective in being, promoting and / or facilitate the formation of an effective antioxidant defense system to contract the glycosylation, hyperglycosylation, oxidation and / or autoxidative glycosylation of whey proteins and proteins that include lipoproteins of the arterial cell wall. Since oxidative stress is a characteristic of diabetes and possibly a contributory factor for among others the oxidation of lipoproteins and / or glycosylation, and since there is no effective antioxidant protection due to for example significantly decreased levels in diabetic subjects of antioxidants such as by Ascorbic acid example, a composition according to the present invention can act effectively as an antioxidant in the prevention of lipoprotein oxidation and / or glycosylation. A composition according to the present invention can effectively act as an antioxidant in the prevention of lipoprotein oxidation and / or glycosylation. By term of autoxidative glycosylation, or glycoxidation, is meant a reaction catalyzed for example by reducing sugars leading to an oxidative modification and / or cross-linking of proteins. The proportion of such a process can be expected to be increased in the presence of high glucose concentrations since the oxidation potential is significantly increased under such circumstances. An increased production of free radicals and lipid peroxidation can also contribute to the formation of autoxidative glycosylated lipoproteins and this contribution can also be effectively prevented and / or eliminated by a composition according to the present invention. According to another currently preferred hypothesis, the binding of a phytoestrogen compound, such as for example isoflavones, optionally in combination with soy peptides provided preferably by hydrolysis of soy protein, to a receptor in the arterial wall, such as for example the estrogen receptor, or an estrogen-like receptor, is involved in or is effective in controlling the uptake of cholesterol and / or triglycerides in the arterial wall, possibly by regulating the permeability of the wall and / or the cholesterol mechanism and / or transport of triglycerides between cell membranes. Consequently, the binding of isoflavones such as for example genistein and / or daidzein to a receptor in the arterial wall can prevent cholesterol and / or triglycerides from entering the arterial wall, or reduce and / or substantially eliminate the amount of cholesterol and / or triglycerides that enter the arterial wall. The binding of the isoflavone receptor in the arterial wall is particularly effective in controlling, preventing and / or eliminating the formation of fat grooves and / or fibrous plaque development and / or effective in mediating a regression of one or both of the arteriosclerotic conditions. . According to a particularly preferred hypothesis, the binding of isoflavones such as for example genistein and / or daidzein to a receptor in the arterial wall, preferably an estrogen receptor or an estrogen-like receptor, results in increased nitric oxide synthesis in the endothelial cells of the arterial wall. Nitric oxide is known to exert anti arteriosclerotic effects including inhibition of adhesion and aggregation of platelets, and proliferation of smooth muscle cells. Soy peptides obtained by hydrolysis of soy protein may participate in the 5-isoflavone bond to an estrogen receptor or to an estrogen-like receptor or the soy peptides may by themselves bind to the receptor and exert an action that leads to a increased synthesis of nitric oxide. In a currently preferred hypothesis, the The establishment of an oxidative potential occurs concomitantly with, and is most likely caused by, a decrease in cellular antioxidant defense systems. This hypothesis is supported by the fact that for example the concentrations of ascorbic acid are decreased in many diabetic individuals. Accordingly, a composition according to the present invention can be effective in acting as an antioxidant. This action reduces and / or eliminates the susceptibility of LDL, VLDL, IDL and / or HDL to oxidation. Concomitantly with an effect As a direct antioxidant, a composition according to the present invention can also decrease the increased levels of serum glucose and in doing so, a composition according to the present invention can be effective in reducing the oxidation potential by causing and / or contributing to an oxidative pressure. & & J3 ^ j ^ ag »Additionally, a composition according to the present invention can also be effective in reducing an increased susceptibility to endothelial damage and / or to alleviate and / or re-establish and / or improve a repair mechanism Endothelial cell One effect of such action exerted by a composition according to the present invention is to direct development of macrophages away from foam cell formation and to increase the potential for generating arterial smooth muscle cells. The unique dyslipidemia associated with type 2 diabetes is a major risk factor for cardiovascular disease and the prevention, alleviation, reduction and / or elimination of dyslipidemia in diabetic subjects is a primary objective of administering a composition according to the present invention to a diabetic individual. Another important objective of such administration is the development in a diabetic subject of gradually reduced insulin resistance and / or gradually improved glucose tolerance. Since increased insulin resistance and impaired glucose tolerance are key elements in the progression of type 2 diabetes, the same factors are for the most part also a natural focus of any preventive treatment. In another currently preferred hypothesis, a composition according to the present invention will promote and / or mediate a reduction in arterial wall thickness and lead to a reduction in the amount of LDL entering the wall. It is believed that an increased thickness of the arterial wall is positively associated with an increased uptake of LDL particles that are likely to either aggregate or oxidize within the cells of the arterial wall. Also, a composition according to the present invention may be able to reduce, eliminate and / or prevent the formation of increased levels in lipoprotein (a) serum in a diabetic subject. Levels of (a) lipoprotein can be determined primarily in genetic form, and no current cardiovascular drugs are taught to be effective in lowering lipoprotein (a) levels in serum. A composition according to the present invention comprises a novel combination of soy protein, preferably isolated soy protein, a phytoe compound: strgenic, preferably naturally occurring isoflavones and dietary fibers, preferably soybean fibers. , more preferably soybean cotyledon fibers. Soy protein can be provided by isolated soy protein, soy protein concentrate, soybean meal or similar or any combination of the same. Soy protein isolated is preferred. Isolated soy protein is the main protein fraction of soybeans. This is prepared from high quality, dehusked soybeans, defatted by eliminating a preponderance of the non-protein components resulting in an isolated soy protein fraction that will contain at least 90 percent protein (N x 6.25) in a base free of moisture. The preparation takes place through a series of stages in which the soybean protein portion is separated from the rest of the soybeans. The elimination of carbohydrates results in a product, which is essentially soft in flavor and therefore particularly useful in a nutritional composition for humans. Soy protein concentrates are made by removing most of the water-soluble non-protein constituents and defatted soybean oil from the dehulled soybeans. In the present context, a soy protein concentrate will preferably contain at least 65 percent protein in a moisture free base. The soy protein may also be provided by soy flour, which may be totally gritty or defatted soy flour. The fully fat soybean meal is made from whole, dehusked soybeans that have been ground into a fine powder and, as the name implies, still contains the fat naturally found in soybeans. Defatted soy flour comes from whole, dehulled, defatted soybeans that have been ground into a fine powder. The soy flour is about 50 percent soy protein on a dry weight basis in the present context. The soy protein used in a composition according to the present invention should preferably deliver all the essential amino acids in the quantities required for humans. Preferably, the soy protein must also meet or exceed the pattern of requirement of essential amino acids for children and adults as established by the Food and Agricultural Organization, World Health Organization and University of the United Nations (FAO / WHO / UNU). Additionally, the preferred soy protein should be comparable in digestibility to the milk, meat, fish and egg protein. Finally, the preferred soy protein should be effective in maintaining nitrogen balance when consumed at the level of recommended protein intake. The preferred isolated soy protein products that meet the aforementioned requirements are supplied by Protein Technologies International, Inc. under the trademark SUPRO®. The proteins of SUPRO® isolated soybeans are supplied in many grades different and SUPRO® XT 12C is a particularly preferred quality. The currently most preferred quality is named SUPR® FXP-H0159. The soy protein is preferably the main or unique protein source in a nutritional composition according to the present invention. However, the portions of the protein source may be provided by other proteins such as for example skim milk, preferably as a powder, and other vegetable or animal proteins including milk proteins. Preferably, at least 45 percent by weight, such as 50 percent by weight, for example at least 60 percent by weight, such as at least 70 percent by weight, for example at least 75 percent by weight, weight, such as at least 80 weight percent, for example at least 85 weight percent, such as at least 90 weight percent, for example at least 95 weight percent, such as less than 98 weight percent of the total protein content of the composition is soy protein, and more preferably substantially all of the protein is soy protein. In a preferred embodiment of the invention the soy protein is provided by isolated soy protein. In this embodiment, preferably at least 50 percent by weight, for example at least 60 percent by weight, such as at least 70 percent by weight, per • at least 75 percent by weight, such as at least 80 percent by weight, for example at least 85 percent by weight, such as at least 90 percent by weight, for example at least 95 percent by weight, such as by at least 98 percent by weight of the total protein content of the composition is isolated soy protein, and more preferably substantially all of the protein is provided by isolated soy protein. The total protein content of a composition 10 according to the present invention provides at least 15 percent of the total energy content of the composition, for example 18 percent, such as at least 20 percent, for example at least 22 percent, such as at least 25 percent, for example at least 28 15 percent, such as at least 30 percent, for example at least 32 percent, such as at least 35 percent, for example at least 38 percent, such as at least 40 percent, for example at least 42 percent, such as at least 45 percent, for example by 20 at least 48 percent, such as at least 50 percent of the total energy content of the composition, and preferably less than 90 percent of the total energy content of the composition. The phytoestrogen compounds according to the present invention are defined as plant substances A) ldtíKUt ?? Sm? -JLJ-t-L l- * i nMÍ m i rm i i n a i 'm • - u ... - _ > . . - -i. .-. • - »- that are found naturally, the substances are either structurally or functionally similar to 17β-estradiol or generate estrogenic effects. Phytoestrogens consist of a number of classes that include isoflavones, coumestans, lignans and lactones of resorcílico acid. Examples of isoflavones according to the present invention are genistein, daidzein, equol, glycitein, biochanin A, formononetin, and O-demethylangolesin. The phytoestrogen compounds of a composition according to the present invention are preferably isoflavones, more preferably genistein, daidzein, glycitein and / or equol, even more preferably genistein and / or daidzein and even more preferably genistein. A preferred composition according to the present invention may therefore comprise a simple isoflavone, such as genistein, daidzein, glycitein, or equol, or this may comprise at least one isoflavone selected from the group consisting of at least genistein, daidzein, glycitein and equol. When they are present in the plant the isoflavones are mainly in a form of glucoside, that is, attached to a sugar molecule. This form of glucoside can be deconjugated to produce a form called aglycone, which is the biologically active species. A composition according to the present invention may comprise isoflavones in the form of glucoside and / or aglycone regardless of whether the deconjugation to the aglycone form has taken place biologically, in vitro or by any other means whereby isoflavones are included in a composition according to the present invention or if the aglycone forms are in the native form of the isoflavones. The phytoestrogen compound is preferably present in an amount of at least about 0.16 weight percent of the soy protein content, such as at least about 0.18 weight percent, for example at least about 0.20 weight percent , such as at least about 0.22 percent by weight, for example at least about 0.24 percent by weight, such as at least about 0.25 percent by weight, for example more than about 0.25 percent by weight, such as at least about 0.26 weight percent, for example at least about 0.28 weight percent, such as at least about 0.30 weight percent, for example at least about 0.32 weight percent, such as at least about 0.33 percent by weight, for example more than about 0.33 percent by weight, such as at least about 0.35 percent by weight, example at least about 0.40 weight percent, such as at least about 0.45 weight percent, for example at least about 0.50 weight percent, such as at least about 0.55 weight percent, for example at least about 0.60 weight percent, such as at least about 0.65 weight percent, for example at least about 0.70 weight percent, such as at least about 0.75 weight percent, for example, less about 0.80 percent by weight, such as at least about 0.85 percent by weight, for example at least about 0.90 percent by weight, such as at least about 1.0 percent by weight of the soy protein content, and preferably less than 2.50 weight percent of the soy protein content. In the past, the downstream processing techniques used in the preparation of soy proteins have included steps that eliminate and / or destroy isoflavones. The methods are currently available, which provide soy protein products with high, fixed levels of naturally occurring isoflavones. The isoflavones according to the present invention in glucoside and / or aglycone forms can be included in a composition according to the present invention as part of such soy protein products and / or by themselves and / or as part of any another composition comprising isoflavones.

The dietary fibers used in the present invention should preferably comprise a mixture of soluble fibers and water soluble fibers also referred to as soluble fibers. Soluble fibers have a diminishing effect on blood cholesterol levels. Examples of dietary fibers comprising soluble fibers are fibers from apples, bananas, oranges, carrots, oats and soybeans. The dietary fibers preferably comprise soluble fibers in an amount of about 5 weight percent, such as about 10 weight percent, for example about 15 weight percent such as about 20 weight percent, for example about 25 weight percent , such as about 30 weight percent, for example about 35 weight percent, such as about 40 weight percent, for example about 45 weight percent, such as about 50 weight percent, for example about 55 weight percent. percent by weight, such as about 60 weight percent, for example about 65 weight percent such as about 70 weight percent, for example about 75 weight percent, such as about 80 weight percent, per example about 85 weight percent, such as * - ^ •• * --- '- • about 90 percent by weight, for example about 95 percent by weight. The dietary fibers used in the present invention are preferably soy bean fibers, more preferably soybean cotyledon fibers. Such fibers are derived from cotyledon of dehusked and defatted soybeans and are comprised of a mixture of soluble and insoluble fibers. The soybean cotyledon fibers are distinctly different from soybean fibers derived from soybean husks as well as other sources of fibers. The soybean cotyledon fibers are soft-flavored, contain no cholesterol, are low in fat and sodium, and have good water binding properties and low caloric content. The soybean cotyledon fibers supplied in a diet modified in fat and low in cholesterol are known to further decrease serum cholesterol levels in a subject suffering from mild to severe hypercholesterolemia. The effect is a decrease in serum cholesterol levels including a decrease in LDL-cholesterol. However, HDL-cholesterol and total triglycerides are not significantly affected by soybean cotyledon fibers. Soy bean fibers, in particular soybean cotyledon fibers, are believed to provide a synergistic effect in combination with soy protein and / or with a phytoestrogen compound, such as naturally occurring isoflavones, or to exercise a potentiating effect on the soy protein and / or the phytoestrogen compound, the synergistic or potentiating effect is effective in decreasing serum lipids and cholesterol levels in subjects having normal serum levels as well as elevated cholesterol levels total and total triglycerides. Without wishing to link to any specific theory, it is currently believed that both soluble dietary fibers (which work as nutrients) and insoluble dietary fibers (which work as bulking agents), in particular soy bean fibers, more particularly soybean cotyledon fibers, provide favorable growth conditions for the microflora in the human intestine, which they do the microflora more effective in deconjugating isoflavones in the form of glucoside to the aglycone form. Isoflavones in the form of aglycone are absorbed faster and to a greater degree in the human intestine than isoflavones in the form of glucoside, and the isoflavones in the form of aglycone are the most biologically active species. In view of the same it can be understood that the administration of a combination of soy proteins, a fixed, high level of isoflavones and a combination of soluble and insoluble fibers is effective in providing an increased uptake of isoflavones. 25 The amount of dietary fiber of the total weight of aa "&? feB -? * - - - • -" •• - -.- • »- a composition according to the present invention on a dry basis is preferably more than 6 weight percent, for example by at least 7 percent by weight, such as at least 8 percent by weight, for example at least 9 by 5 percent by weight, such as at least 10 percent by weight, for example at least 11 percent by weight, such as at least 12 weight percent, for example at least 13 weight percent, such as at least 14 weight percent, for example at least 15 weight percent, such as at least 16 weight percent, for example at least 17 weight percent, such as at least 18 weight percent, for example at least 19 weight percent, teil as at least 20 weight percent percent by weight, and preferably less than 50 percent by weight. Preferred amounts of dietary fiber as one percent by weight of the soy protein content, should be in the range of about 10 to 100 weight percent, and preferred amounts are in the range of 15 to 90 weight percent, such as from 20 to 80 percent in weight, for example 25 weight percent, such as 30 weight percent, for example 33 weight percent, such as 35 weight percent, for example 40 weight percent, such as 50 weight percent , for example 60 percent by weight, such as 70 percent by weight, for example 75 percent percent by weight.

Accordingly, the weight ratio of soy protein to dietary fibers is from about 1.0 to about 10.0, preferably more than about 1.0, for example about 1.24, such as at least about 1.5, for example at least about 1.75, such as at least about 2.0, for example at least about 2.25, such as at least about 2.5, for example at least about 2.75, such as at least about 3.0 for example at least about 3.25, such as at least less about 3.5, for example at least about 3.75, such as at least about 4.0, for example at least about 4.25, such as at least about 4.5, for example at least about 4.75, such as at least about 5.0, for example at least about 5.5, such as at least about 6.0, for example at least Approximately 7.5. The preferred daily dose of soy bean fibers is from at least 1 g to about 100 g of soy bean fibers, for example from at least 2 to about 75 g of soy bean fibers, such as from less about 3 g to about 50 g, for example from at least 4 to about 40 g, such as from at least 5 to about 30 g, such as at least . . - " - .."to- .. * . r,. i »-. ,, "Awwaft-i minus 10 g to about 20 g of soybean fibers. The preferred soybean cotyledon fiber products manufactured by Protein Technologies International, Inc. are sold under the trademark of FIBRIM®. Among the various soy bean fibers produced under the FIBRIM® brand, FIBRIM® 1020 is particularly preferred because of a particularly pleasant taste and dispersibility for dry mixed beverage applications. FIBRIM® 2000 is currently preferred for use in liquids ready to be prepared. Two soybean protein and soybean cotyledon fiber compositions are preferred in order to maximize the soy protein and isoflavone content contained therein ie SUPRO® FXP-H0159 and FRIBRIM® 1020 for dry mixed beverage applications. and SUPRO® FXP-H0159 and FIBRIM® 2000 for use in ready-to-prepare liquids. Alternatively, the present invention provides a composition wherein no soy protein is present and 0 where the dietary fibers are soybean cotyledon fibers. This composition comprises soybean cotyledon fibers in an amount of more than 4 weight percent of the total weight of the composition in a dry base, and at least one phytoestrogen compound in an amount of more than 0.10 by 5 weight percent of the soybean cotyledon fibers of the »* ---« - - * - * * - * * composition. The present invention also provides the use of such a composition as a medicament and / or in the manufacture of a medicament effective in treating and / or relieving type 2 diabetes, the metabolic syndrome or a cardiovascular disease associated therewith in subjects with diabetes and / or the metabolic syndrome. The present invention also provides the use of such a composition and / or such composition for use in treating type 2 diabetes, metabolic syndrome or related cardiovascular diseases in a subject. When no soy protein is present in the composition, the phytoestrogen compound is preferably present in an amount of at least about 0.12 weight percent of the soybean cotyledon fiber content, such as at least about 0.14 percent by weight. weight, for example at least about 0.16 weight percent, such as at least about 0.18 weight percent, for example at least about 0.20 weight percent, such as at least about 0.22 weight percent, for example at least about 0.24 percent by weight, such as at least about 0.25 percent, for example more than about 0.25 percent by weight, such as at least about 0.26 percent by weight, for example at least about 0.28 weight percent, such as at least about 0.30 percent by weight, for example at least about 0.32 weight percent, such as at least about 0.33 weight percent, for example more than about 0.33 weight percent, such as at least about 0.35 percent by weight, for example at least about 0.40 weight percent, such as at least about 0.45 weight percent, for example at least about 0.50 weight percent, such as at least about 0.55 percent by weight by weight, for example at least about 0.60 percent by weight, such as at least about 0.65 percent by weight, for example at least about 0.70 percent by weight, such as at least about 0.75 percent by weight. weight, for example so At least about 0.80 percent by weight, such as at least about 0.85 percent by weight, for example at least about 0.90 percent by weight, such as at least about 1.00 percent by weight, for example at least approximately 1.25 percent in Weight, such as at least about 1.50 weight percent, for example at least about 1.75 weight percent, such as at least about 2.00 weight percent, for example at least about 2.50 weight percent , such as at least About 3.00 percent by weight, for example at The present invention relates to at least about 3.5 percent by weight, such as at least about 5.00 percent by weight of the soybean cotyledon fiber content of the composition and preferably less than 10.00 percent by weight. 100 weight percent of the soybean cotyledon fiber content of the composition. Alternatively, the present invention provides a composition wherein dietary fibers are not present. This composition comprises soy protein, preferably soy protein isolated in an amount of at least 50 percent by weight of the total protein content of the composition, the total protein content providing at least 15 percent of the total energy content of the composition, and at least one phytoestrogen compound in an amount of more than 0.10 weight percent of the soy protein content of the composition. The present invention also provides for the use of such composition > n in the treatment of diabetic subjects, the treatment that is particularly effective in decreasing levels of serum glucose and lipids in a subject. The present invention also provides the use of such a composition comprising soy protein and a phytoestrogen compound as a medicament and / or in the manufacture of a medicament for treating diabetic subjects, the treatment that is effective in decreasing serum levels of glucose and / or insulin and / or lipids. The present invention also provides the use of such a composition as a medicament and / or in the manufacture of a medicament effective in treating and / or relieving type 2 diabetes, the metabolic syndrome as defined herein and / or any cardiovascular disease associated with the same in a subject. A composition according to the present invention may optionally comprise a source of carbohydrates, a source of fats, flavoring agents, vitamins, minerals, electrolytes, trace elements and other conventional additives. The nutritional composition according to the present invention may in one embodiment also comprise one or more flavoring agents such as cocoa, vanilla, limes, strawberries or soup flavor, such as mushrooms, tomatoes or broths and / or sweeteners such as aspartame as well as also other additives such as xanthan gum. When a carbohydrate source is present in a composition according to the present invention, it is preferably present in an amount of less than 30 weight percent such as less than 25 weight percent of the composition. Preferably, the amount of carbohydrate amounts to at least 5 percent by weight, more preferably at least 10 percent by weight, and most preferred at least 15 percent by weight, of the composition. Particularly preferred cocoa reduced in lecitinated fat. Other preferred carbohydrates for use in a composition according to the present invention are polydextrose or sucrose, but these should be limited by using other similar sweeteners such as aspartame. When a source of fats is present in a composition according to the present invention, it is usually present in an amount of 0.5 to 10 weight percent, preferably 1 to 9 weight percent, such as 1.5 to 8 percent by weight, for example from 2 to 7 percent by weight, such as from 2.5 to 6 weight percent of the composition. The fat source will preferably comprise polyunsaturated fatty acids and monounsaturated fatty acids and optionally saturated fatty acids as well. Particularly preferred are soy lecithins and α-linolenic acids. The amount of polyunsaturated fatty acids and monounsaturated fatty acids, including essential fatty acids, can be in the range of 35 to 50, preferably 38 to 44, percent by weight of the total amount of the fat source. The essential fatty acids are also called omega-6 and omega-3 fatty acids and include linolic acid and / or linolenic acid (a-linolenic acid). The amount of saturated fatty acids can be from 20 to 30 weight percent, preferably 22 to 26 weight percent, of the total amount of fat. 25 Vitamins can be added optionally ---- < «- ~« i * = fa - ^ »- minerals to a composition according to the present invention in accordance with the limits indicated by health authorities. Vitamins will typically include A, Bl, B2, B12, folic acid, niacin, pantothenic acid, 5 biotin, C, D, E, and K. Minerals will typically include iron, zinc, iodine, copper, manganese, chromium, and selenium. Electrolytes, such as sodium, potassium and chlorides, trace elements and other conventional additives can also be added in recommended amounts. A preferred composition can be obtained by mixing: Content per 100 grams (%) Isolated soy protein 50.00 (SUPRO® FXP-H0159) Soy bean fibers 16.70 (FIBRIM® 1020) Carbohydrates 18.20 Reduced fat cocoa 9.30 lecithin Soy lecithin 3.55 Flavors 1.25 Xanthan gum 0.50 Aspartame 0.50 • tpiiilW? LMh * 1"" - - - • - »- * - * A composition according to the present invention can be used as a food for special dietary use, preferably to decrease serum glucose levels and / or decrease levels in insulin serum and / or to decrease total serum cholesterol and / or LDL-cholesterol and triglyceride levels and / or to increase glucose tolerance and / or insulin sensitivity and / or to prevent and / or alleviate and / or treat impaired tolerance to glucose and / or insulin secretory failure in diabetic subjects and / or to avoid and / or relieving and / or treating an arteriosclerotic condition by reducing the influx of lipoproteins and / or cholesterol and / or triglycerides in the endothelium of an arterial wall of a diabetic subject suffering from cardiovascular disease. For example, one to three meals a day of food Ordinary may be supplemented or replaced by a composition according to the present invention. For this reason, significant reductions in serum levels of total cholesterol and LDL-cholesterol and triglycerides can be obtained, as well as an improvement in the proportion of HDL / LDL-cholesterol and / or an increase in serum HDL-cholesterol levels. The composition can provide 50 to 250 kcal per serving. The present invention also provides a composition according to the invention in the form of a micronutrient. In this connection, a micronutrient is a Ifa ^ aim ^ a »^., Nutritional supplement and / or a pharmacological composition and / or a medicament comprising i) a compound similar to synthetic phytoestrogen capable of binding an estrogen receptor or estrogen-like receptor, and / or ii (a plant-extractable compound, which is found naturally in an amount, on a weight basis by weight, in excess of the amount of the compound, when present in a natural host such as a plant cell of the which compound can be extracted or isolated, and optionally iii) soy peptides obtainable from partial hydrolysis of soy protein. The plant-extractable compound, which is found naturally, is preferably but not limited to compounds capable of binding to an estrogen receptor, a Estrogen-like receptor, a beta-2-adrenergic receptor, or a receptor belonging to the beta-2-adrenergic receptor cascade. When naturally occurring compounds are isolated from plants such as soybeans, they can be selected from the group that contains at least phytoestrogens such as soybean phytoestrogens such as soybean isoflavones, soy protein or fragments thereof, for example peptides or amino sequences, soybean fibers, lecithin, linolenic , a antioxidant, a saponin, a lignan, a protease inhibitor, a '• * a * BM ^ it'-' '• --- i --i - »- trypsin inhibitor, and a tyrosine kinase inhibitor. Additional constituents of the micronutrient may preferably be selected from a DNA topoisomerase inhibitor, a ribosome kinase inhibitor, a growth control factor, such as for example an epidermal growth factor, a transforming growth factor alpha, derived growth factor. of platelets, and preferably any growth control factor controllable by tyrosine activity kinase. The micronutrient may also comprise ormeloxifene and / or levrmeloxifene as described among others by Holm et al. (1997) in Arteriosclerosis, Thrombosis, and Vascular Biology 17 (10), 2264-2272, and in Clinic Investigation 100 (4), 821-828. When the compound that is found naturally, is an isoflavone, the isoflavone may have been deconjugated to the aglycone form either biologically or in vitro before incorporation into the micronutrient. In a particularly preferred embodiment The present invention provides a composition or a micronutrient according to the present invention in combination with a functional food ingredient comprising a sterol, preferably an ingredient selected from the group consisting of a stanol ester, a tocotrienol, a mevinolin, and a phytosterol compound such "ri" '- • * - **' 'as for example, campesterol sitosterol or stigmasterol or a combination thereof. According to a preferred embodiment, a composition or a micronutrient according to the present invention is for use as a functional food ingredient. A composition or a micronutrient according to the present invention can also be administered as a probe or by intravenous administration, or in the form of a tablet or capsule. The present invention also provides a pharmaceutical preparation comprising the composition or a micronutrient according to the present invention, use of a composition or a micronutrient according to the present invention in therapy and / or diagnostic method performed in the human or animal body, use of a composition or a micronutrient according to the present invention in the manufacture of a medicament and use of a composition or a micronutrient according to the present invention in the manufacture of a medicament for treating a subject suffering from type 2 diabetes, the metabolic syndrome or cardiovascular diseases associated with it. The micronutrient is particularly useful in the prevention and / or treatment of type 2 diabetes, the metabolic syndrome and cardiovascular diseases associated therewith in a diabetic subject. In one embodiment the present invention provides a composition according to the present invention for use as a medicament or as a diet preparation. A composition according to the present invention for use as a medicament or as a dietary preparation can be used in preventing, alleviating, eliminating and / or treating type 2 diabetes and / or a cardiovascular disease associated therewith. The present invention also provides the use of a composition according to the present invention for the manufacture of a medicament for preventing, alleviating and / or treating type 2 diabetes and / or cardiovascular disease in a dieibetic subject. A composition according to the present invention for use as a medicament and / or the use of a composition according to the present invention for the The manufacture of a medicament for treating a subject with diabetes and / or the metabolic syndrome and / or a cardiovascular disease associated therewith can be effective in i) lowering serum glucose levels and / or ii) reducing the influx of cholesterol and / or triglycerides in the arterial wall and / or the amount of oxidized LDL-cholesterol present in the arterial wall and / or iii) decrease total serum cholesterol and / or serum LDL-cholesterol and / or serum triglyceride levels and / or serum homocysteine levels and / or increase the proportion of HDL / LDL-cholesterol and / or HDL-25 serum cholesterol and / or iv) increasing glucose tolerance ? ^^^^^ m? iittíii ^ ^^^ J. and / or insulin sensitivity and / or v) alleviating impaired glucose tolerance and / or secretory insulin failure and / or vi) preventing, alleviating, eliminating and / or treating cardiovascular diseases, such as hypertriglyceridemia, hypercholesterolemia, arteriosclerosis, atherosclerosis arteriolosclerosis, angina pectoris, thrombosis, myocardial infarction, hypertension, hyperglycemia and hyperinsulinemia in a diabetic subject. A composition according to the present invention for use as a medicament and / or the use of a composition according to the present invention for the manufacture of a medicament can also be effective in treating cardiovascular diseases such as for example fat groove formation. and / or development of fibrous plaque and / or development of complicated injury. Additionally, a composition according to the present invention for use as a medicament and / or the use of a composition according to the present invention for the manufacture of a medicament may also be effective in treating a procoagulant state and / or an increased activity coagulation factors, insulin resistance, glycosylation and / or oxidation and / or chemical modification of lipoproteins, as well as tolerance to glucose damaged. The present invention also provides a method for preventing and / or treating by type 2 diabetes therapy and / or the metabolic syndrome in a human or animal body, the method comprising administering to the human or animal body, a composition according to the present invention in an effective amount to decrease serum glucose levels and / or reduce the influx of cholesterol and / or triglycerides in the arterial wall and / or reduce the amount of oxidized LDL-cholesterol present in the arterial wall and / or decrease cholesterol levels in serum and / or decrease LDL-cholesterol levels and / or decrease serum triglyceride levels and / or serum homocysteine levels and / or improve glucose tolerance and / or increase sensitivity to insulinei and / or relieve impaired tolerance to the glucose and / or improving insulin secretion and / or reducing or eliminating fat groove formation and / or avoiding, reducing, or eliminating fibrous plaque formation and / or avoiding, reducing or eliminating injury formation n complicated and / or avoid, reduce or eliminate the risk of a subject of contracting angina pectoris and / or avoid, reduce, or eliminate the risk of a subject of contracting a myocardial infarction and / or avoid, treat, treat prophylactically, alleviating and / or eliminating hypertension and / or hyperglycemia and / or hyperinsulinemia and / or hypercholesterolemia and / or hypertriglyceridemia and / or arteriosclerosis and / or atherosclerosis and / or arteriolosclerosis in a diabetic subject. The treatment period is preferably in the range of 1 to 12 months or more, such as 2 weeks to 9 months, for example 3 weeks to 6 months, such as 4 weeks to 4 months, such as 6 weeks to 3 months. However, the period of treatment will not be limited to these periods and may for example be as long as 12 months, such as for example a long-life treatment in order to prevent and / or relieve type 2 diabetes and / or a cardiovascular disease in connection with it. In one embodiment the present invention provides a pharmaceutical preparation comprising a composition of according to the present invention. The pharmaceutical preparation can be prepared in any manner known to the skilled person. In another embodiment, the present invention provides the use of a composition according to the present invention.

Invention in the manufacture of a nutritional preparation for decreasing serum glucose levels and / or serum cholesterol levels and / or serum LDL-cholesterol levels and / or serum triglyceride levels and / or serum homocysteine levels and / or to increase the proportion of HDL / LDL-cholesterol and / or serum HDL-cholesterol levels in a diabetic subject. Nutritional preparation can take any form, which is suitable for human or animal consumption,. In a preferred embodiment, the composition is a powder mixture, which is suspendable, dispersible or Emulsifiable in a liquid for human or animal consumption. He The liquid is preferably a liquid containing water, such as water, coffee, tea or juice, for example. For such purpose, the composition can be packaged in a package proposed to cover part of the total nutritional requirement for a defined period of time, such as a period of for example three days or a week. The present invention also provides the nutritional preparation in the form of a dietary supplement. Nutritional preparation in a modality of the The present invention is preferably a functional food or drink, ie an easily obtained edible or drinkable substance that is supplemented with a composition according to the present invention to provide a medical or pharmaceutical effect. By Accordingly, the present invention provides a composition according to the present invention for use as a functional food ingredient. Functional foods and beverages are preferably selected from the group consisting of daily products, such as yogurt, and yoghurt ice cream, juice such as orange juice or tomato juice, liquids ready to be prepared for drinking, a dispersible product such as for example margarine or an oil extracted from plants or vegetable, a cereal product, such as traditional breakfast cereal, bars nutritional, cross-eyed, bread, soups, such as tomato soup, -'- • "r" - »^. i - a meat product, such as a hamburger, a meat substitute, and a vegetable product. In a further embodiment, a nutritional preparation according to the present invention may be in the form of a liquid ready to be prepared or in a powder form or in the form of a troche, a solid composition such as a nutritional bar, a bar of fruit, a cookie, a cake, a bread or a muffin. In another embodiment, a composition according to the present invention is a liquid nutritional preparation in a liquid containing water, in which the solid ingredients are suspended, dispersed or emulsified in an amount of 10 to 25 weight percent. When the liquid nutritional preparation for drinking is proposed, it will usually comprise a flavoring agent as discussed above. However, the liquid nutritional preparation can also be used for administration by gavage. In another embodiment, the present invention relates to the use of a composition according to the present invention as a partial or total diet for an overweight subject or an overweight subject suffering from a diabetic condition. It is believed that obesity is one of the leading causes of diabetes including type 2 diabetes. Overweight diabetic subjects frequently have an increased serum cholesterol level and an increased triglyceride level and are therefore more likely to develop cardiovascular diseases . However, the present invention is not limited to treating diabetic subjects with an increased risk of contracting cardiovascular disease, ie obese diabetic subjects will likely have increased serum cholesterol and / or triglyceride levels. A composition according to the present invention also has a substantial diminishing effect of serum cholesterol, Serum LDL-cholesterol and serum triglycerides in diabetic subjects who do not also suffer from overweight. For the purpose of the present invention, subjects having an initial total serum cholesterol level of 5.7 mmol / 1 or below are considered to have a hypocholesterolemic or normal level, while subjects having a serum total cholesterol level above 5.7 mmoleß / 1 is considered to be hypercholesterolemic. Accordingly, when treating normocholesterolemic subjects, it is possible to prevent the development of cardiovascular diseases that originate from serum cholesterol levels below a concentration of 5.7 mmoles / 1 in diabetic subjects particularly sensitive to developing eg arteriosclerosis, or to prevent further development of cardiovascular diseases in diabetic patients with previous ceirdiovascular events. Example 1 The study is carried out as a cross study that covers 2 x 6 weeks. In the first six weeks, one-third of the ingredients receives a composition according to the invention (Abalon®, Nutri Pharma ASA, Oslo) containing 50% isolated soy protein, a fixed high uptake of isoflavones (3.7 mg / g) protein) and 16.7% of soybean cotyledon fibers while the other half receives a placebo product with the same amounts of protein and fiber. In the period of the second six weeks, patients who have received Abalon® in the first period now receive the placebo product and vice versa. Every two weeks the patients are examined for something from a wide range of factors, which are involved in the metabolic syndrome and type 2 diabetes. The following Tables 1-V summarize the results of this examination.

TABLE I Treatment sequence Active / Placebo Placebo / Active Variable Visit N Average DE Wilcoxon N Average DE Wilcoxon Mann- Whitney ColesVisit 1 12 5.80 0.93 8 5.85 0.90 Ns terol Visit 3 12 5.15 0.87 8 5.44 0.77 Ns total Df 1/3 12 0.65 0.44 0.0015 8 0.41 0.79 Ns Ns mmol / l Visit 4 12 5.42 0.74 8 5.51 0.72 Ns Visit 6 12 5.46 0.98 8 5.04 0.65 Ns Dif 4/6 12 -0.03 0.55 ns 0.47 0.31 0.156 0.0485 Visit 1 12 1.32 0.26 8 1.20 0 .19 HDL- Visit 3 12 1.42 0.43 8 1.30 0. .13 ns cabbage- Dif 1/3 12 -0.10 0.23 ns 8 -0.10 0. .22 terol Visit 4 12 1.33 0.34 8 1.29 0. .14 mmol / 1 Visit 6 12 1.36 0.43 8 1.31 0. .16 ns Dif 4/6 12 -0.02 0.18 ns 8 -0.03 0. .15 Visit 1 11 3.75 0.92 7 3 .90 0 .86 Visit 3 11 3.06 0.80 8 3 .44 0 .59 LDL- Df 1/3 11 0.69 0.36 0.0010 7 0 .46 0 .73 ns cabals- Visit 4 11 3.48 0.76 8 3 .46 0 .54 terol Visit 6 11 3.25 0.83 8 2 .94 0. .53 mmol / 1 Dif 4/6 11 0.23 0.40 ns 8 0, .53 0. .24 0.0078 TABLE I (continued) Sequence of treatment Active / Placebo Placebo / Active Variable Visit N Average Wilcoxon N Median DE Wilcoxon Mann- Whi ney Trigli- Visit 1 12 1.68 1.24 8 1.80 1.6 Ns Ceridos Visit 3 12 1.57 1.02 8 1.56 0.65 Ns mmol / 1 Df 1/3 12 0.12 0.44 Ns 8 0.24 1.03 ns Ns Visit 4 12 1.63 1.45 8 1.71 1.15 Ns Visit 6 12 1.94 1.43 8 1.72 0.96 Ns Dif 4/6 12 -0.31 0.44 0.0225 8 -0.01 0.40 ns ps Apolip. B Visit 1 12 1.07 0. .21 8 1. .06 0 .27 ns mmol / 1 Visit 3 12 0.82 0 .20 8 0. .95 0 .29 ns Dif 1/3 12 0.26 0 .12 0.0005 8 0. .11 0 .25 ns ns Visit 4 12 0.87 0. .22 8 1., 11 0. .21 0.0265 Visit 6 12 1.01 0 .22 8 0. .93 0. .17 ns Dif 4/6 12 -0.14 0 .23 ns 8 0. .19 0 .14 0.0156 0.0022 Homo- Visit 1 12 11.38 4 .67 8 10. .68 2 .40 cysteine Visit 3 12 11.48 4 .74 8 11 .80 2 .48 μmol / 1 Df 1/3 12 -0.19 1 .22 ns 8 -1. 13 0 .84 0.0234 Visit 4 12 10.52 2 .80 8 10 .88 2 .61 Visit 6 12 13.27 5. .78 8 11 .70 2 .75 Dif 4/6 12 -2.74 3 3. .1177 0 0 .. 0 0000055 8 8 --00. .8833 0 0. .7711 0 0..00331133 0.0163 In this teibla, Active / Placebo refers to patients who have received AJoalon® during the first six weeks (visit 1-3) and placebo for the last two six weeks while Placebo / Active refers to the opposite situation; ns is not significant and Wilcoxon and Mann-Whitney are the statistical methods used TABLE II Active period Placebo period Difference Var. Visit N Media DE Wil. N Average DE Wil. N Average DE Wil Total Visit 1 20 5.68 0.84 20 5.59 0.81 20 0.09 0 66 ns c ol. Visit 3 20 5.11 0.78 20 5.45 0.88 20 -0.34 0.50 0.0041 Dif 1/3 20 0.58 0.39 0.0001 20 0.14 0.68 ns 20 0.43 0.90 ns HDL- Visit 1 20 1.31 0.22 20 1.28 0.29 20 0.03 0.19 ns c ol. Visit 3 20 1.38 0.35 20 1.33 0.34 20 0.04 0.14 ns Dif 1/3 20 -0.07 0.20 ns 20 -0.05 0.20 ns 20 -0.02 0.24 ns LDL- Visit 1 19 3.G3 0.78 18 3.64 0.80 18 -0.00 0.66 ns chol. Visit 3 19 3.01 0.68 19 3.33 0.72 19 -0.32 0.40 0.004 Dif 1/3 19 0.02 0.32 0.0001 18 0.32 0.54 0.0220 10 0.32 0.67 ns TG Visit I 20 1.70 1.17 20 1.70 1.49 20 -0.01 0.58 ns Visit 3 20 1.63 0.97 20 1.79 1.17 20 -0.16 0.57 ns Dif? / 3 2o 0.07 0.42 ps 20 -0.09 0.76 ns 20 0.16 0.78 ns ? B Visit 1 20 1.09 0.21 20 0.95 0.26 20 0.15 0.29 ns Visit 3 20 0.86 0.19 20 0.98 0.25 20 -0.12 0.22 0.0249 Dif l / 3 20 0 23 0 13 0 0001 20 -0.04 0.26 ns 20 0.27 0.35 0.0026 Homo- Visit 1 2Q ^ 18 3 go 2Q 1Q 58 2 58 2Q Q 5g 1 gQ ns Visit 3 cys 20 11.57 3.97 20 12.68 4.71 20 -1.11 1.58 0.0040 Dlf l 3 20 -0.38 1.09 ns 20 -2.10 2.60 0.0001 20 1.71 2.98 0.0057 In this table TG = triglycerides, Apo B = apoliprotein B, Homo-cys = homocysteine, ns = not significant, Wilcoxon is the statistical method used and all units similar to Table 1.

TABLE III% CHANGE Active Variable Placebo Difference Total cholesterol -10.1 -2.5 7.6 HDL-cholesterol 5.3 3.9 1.4 Triglycerides -4.1 5.3 9.4 Apolipo B 100 -21.2 4.2 25.3 homocysteine 3.4 19.8 16.4 TABLE IV Active Treatment Placebo Variable Visit Media of Wil- Medía DE Wilcoxon Mann- Whitney Glucose Visit 1 12 2736 872 8 2360 772 0.1325 mmol / 1 Visit 4 12 2903 1159 8 2476 1021 0.3749 Dif V. 12 167 472 0.4697 8 117 294 0.6406 0.9079 Insulin Visit 1 12 44436 28492 8 47125 19356 0.5120 IU / ml Visit 4 12 45057 29561 8 42405 19488 0.9692 Dif 1/4 12 621 7682 0.8501 8 -470 6019 0.0781 0.1325 IU = International Units, Wilcoxon and Mann-Whitney are the statistical methods TABLE V Sequence of treatment Ac ivo / Placebo Pl acebo / Ac ivo Variable Visit to Media DE Wil - Medía DE Wilcoxon. { lann- Whi tney Glucose 3-1 12 204 379 0.1099 8 189 223 0 0078 0. 9692 mmol / l 6-4 12 284 441 0.0269 8 -16 147 0. 8437 0. 0409 Insulin 3-1 12 26323 40064 0.0005 8 0.7285 IU / l 6-4 12 28377 30798 0.0010 8 26267 22637 0.0078 0.9079 IU = International Units, Wilcoxon and Mann-Whitney are the statistical methods used In this study it is shown that Abalon® in the given dose and for the given time reduces the amount of total cholesterol, reduces the amount of LDL-cholesterol, reduces the amount of Apolipoprotein B 100, and results in a different level of homocysteine than placebo. A significant difference between the Abalon® group and the placebo group is expected with respect to total cholesterol, but the low number of patients and the design of the study have probably made the results less clear. The same may be true for glucose and insulin levels, where a longer period of study may have probably revealed a greater difference between Abalon® and placebo. Other unpublished studies regarding the cholesterol lowering effect of a composition according to the invention show, that the effect is obtained more and more pronounced with time (up to four months). Example 2 The objective of the present study is to examine whether a product comprising isolated soy protein, soy bean fibers, and a high, fixed level of isoflavones, is significantly more effective in lowering serum LDL-cholesterol and total cholesterol levels than the placebo. The study is performed as a randomized, double-linked, placebo-controlled trial. Fifty-two patients with an average baseline cholesterol level of 7.6 mmol / l complete a six-week treatment. Twenty-four consume a composition according to the invention (Abacor®, Nutri Pharma Asa, Oslo) containing isolated soy protein with high, fixed levels of isoflavones, and soybean cotyledon fibers (52 g of soy protein, 230 mg of soybean protein). soy isoflavones, and 15.5 g of soybean cotyledon fibers, per day). Twenty-eight consume a product with the same protein and fiber intakes, based on casein and cellulose (the placebo). The preparations are given as two daily liquid supplements in addition to the patient's regular diets. Both groups are checked one month after stopping to take the preparations. The average reduction of LDL-cholesterol in the group treated with Abacor® after six weeks is 13-1%, while it is 7.8% (p = 0.014) in the group treated with placebo. The reduction of total cholesterol is also greater in the active group compared to that of placebo (8.4% vs. 5.1%, p = 0.049), uncorrected for multiple testing. High density lipoprotein (HDL) cholesterol shows an increase in both active and placebo groups (6.2% vs. 5.8%). A month later both groups have returned to pretreatment cholesterol levels. The results show that ingestion of a product comprising isolated soy protein with high levels, fixed isoflavones, and soybean cotyledon fibers, significantly reduces LDL-cholesterol and total serum cholesterol, and improves the proportion of HDL / LDL- cholesterol. Positive results are achieved in this group of patients after just six weeks of treatment.

Claims (60)

1. CLAIMS 1. A composition characterized in that it comprises: (a) a source of soy protein, selected from isolated soy protein, soy protein concentrate, or soybean meal, the source of soy protein providing a quantity of soy protein , which is at least 45 percent by weight of the total protein content of the composition, the total protein content providing at least 15 percent of the total energy content of the composition; (b) at least one phytoestrogen compound in an amount of more than 0.16 weight percent of the soy protein content of the composition, and (c) dietary fibers in an amount of more than 6 weight percent of the weight total nutritional composition on a dry basis.
2. 2. A composition according to claim 1, characterized in that the soy protein source is isolated soy protein and the amount of isolated soy protein is at least 50 weight percent of the total protein content.
3. 3. A composition according to claim 2, characterized in that the amount of isolated soy protein is at least 75 weight percent of the total protein content.
4. 4. A composition according to claim 3, characterized in that the amount of isolated soy protein is at least 90 percent by weight of the total protein content.
5. 5. A composition according to claim 4, characterized in that substantially all of the protein is isolated soy protein.
6. 6. A composition according to claim 1, characterized in that the source of soy protein is concentrate of soy protein or soybean meal and the amount of soy protein is at least 50 weight percent of the total protein content. .
7. 7. A composition according to claim 6, characterized in that the amount of soy protein is at least 75 weight percent of the total protein content.
8. 8. A composition according to claim 7, characterized in that the amount of soy protein is at least 90 percent by weight of the total protein content.
9. 9. A composition according to claim 8, characterized in that substantially all the protein is soy protein.
10. 10. A composition according to any of claims 1 to 9, characterized in that the dietary fibers are soy bean fibers.
11. 11. A composition according to claim 10, characterized in that the soy bean fibers are soybean cotyledon fibers.
12. 12. A composition according to any of claims 1 to 11, characterized in that the phytoestrogen compound is present in an amount of at least about 0.20 weight percent of the soy protein content of the composition.
13. 13. A composition according to claim 12, characterized in that the phytoestrogen compound is present in an amount of at least about 0.30 weight percent of the soy protein content of the composition.
14. 14. A composition according to claim 13, characterized in that the phytoestrogen compound is present in an amount of at least about 0.33 weight percent of the soy protein content of the composition.
15. 15. A composition according to claim 14, characterized in that the phytoestrogen compound is present in an amount of at least about 0.45 weight percent of the soy protein content of the composition.
16. 16. A composition according to claim 15, characterized in that the phytoestrogen compound is present in an amount of at least about 0.75 weight percent of the soy protein content of the composition.
17. 17. A composition according to claim 16, characterized in that the phytostrogenic compound is present in an amount of at least about 1.0 weight percent of the soy protein content of the composition.
18. 18. A composition according to any of claims 1 to 17, characterized in that the phytoestrogen compound is selected from isoflavones.
19. 19. A composition according to claim 18, characterized in that the isoflavones are selected from the group consisting of genistein, daidzein, glycitein and equol.
20. 20. A composition according to claim 19, characterized in that the isoflavones are genistein and / or daidzein.
21. 21. A composition according to claim 20, characterized in that the isoflavone is genistein.
22. 22. A composition according to any of claims 18 to 21, characterized in that some or all of the isoflavones are present in aglycone form.
23. 23. A composition according to any of claims 1 to 22, characterized in that the dietary fibers are present in an amount of at least 7 weight percent of the composition.
24. 24. A composition according to any of claims 1 to 23, characterized in that the weight ratio of soy protein to dietary fiber is at least about 1.0.
25. 25. A composition according to claim 24, characterized in that the weight ratio of soy protein to dietary fiber is at about 1.5.
26. 26. A composition according to claim 25, characterized in that the weight ratio of soy protein to dietary fiber is at least about 2.0.
27. 27. A composition according to claim 26, characterized in that the weight ratio of soy protein to dietary fiber is at least about 2.5.
28. 28. A composition according to claim 27, characterized in that the weight ratio of soy protein to dietary fiber is at least about 3.0.
29. 29. A composition according to claim 28, characterized in that the weight ratio of soy protein to dietary fiber is at least about 4.0.
30. 30. A composition according to claim 29, characterized in that the weight ratio of soy protein to dietary fiber is at least about 5.0.
31. 31. A composition according to any one of claims 1 to 30, further characterized in that it comprises an additional protein source and / or an additional carbohydrate source and / or an additional fat source.
32. 32. A composition according to claim 31, characterized in that the source of additional fat is selected from soy lecithins.
33. 33. A composition according to claim 31, characterized in that the source of additional fat is selected from polyunsaturated and monounsaturated fatty acids.
34. 34. A composition according to any of claims 1 to 33, characterized in that it is in the form of a micronutrient.
35. 35. A composition according to claim 34, characterized in that it additionally comprises a DNA topoisomerase inhibitor, a ribosome kinase inhibitor, and / or a growth control factor.
36. 36. A composition according to claim 35, characterized in that the growth control factor is a growth control factor controllable by tyrosine kinase activity.
37. 37. A composition according to any of claims 34 to 36, further characterized in that it comprises ormeloxifen and / or levormeloxifen.
38. 38. A composition according to any of claims 1 to 37, characterized in that it is in combination with a functional food ingredient comprising sterol.
39. 39. A composition according to claim 38, characterized in that the functional food ingredient comprising a sterol is selected from the group consisting of a stanol ester, a tocotrienol, a mevinolin, and a phytosterol compound, or a combination thereof .
40. 40. A composition according to any of claims 1 to 39, characterized in that it is used as a functional food ingredient.
41. 41. A composition according to claim 40, characterized in that the functional food is selected from the group consisting of daily products, juice, ready-to-drink liquids, a dispersible product, a cereal product, nutritional bars, croissants, bread, soups, meat products, meat substitute products, and a vegetable product.
42. 42. A composition according to any of claims 1 to 41, characterized in that it is for special dietary use.
43. 43. A composition according to claim 42, characterized in that it decreases levels of 10 glucose and / or total cholesterol and / or LDL-cholesterol and / or serum triglycerides in a diabetic subject.
44. 44. A composition according to claim 42, characterized in that it decreases serum glucose levels and / or decreases serum insulin levels. 15 and / or decreases total serum cholesterol and / or serum LDL-cholesterol and / or triglyceride levels and / or increases glucose tolerance and / or insulin sensitivity and / or prevents and / or alleviates and / or treats impaired tolerance to glucose and / or insulin secretory failure in diabetic subjects and / or prevent and / or relieve and / or 20 treats an arteriosclerotic condition by reducing the influx of lipoproteins and / or cholesterol and / or triglycerides in the endothelium of the arterial wall of a diabetic subject suffering from cardiovascular disease.
45. 45. A composition according to any one of claims 1 to 44, characterized in that it is used - - - «- *" - "-" - as a medicine
46. 46. A composition according to claim 45, characterized in that it is used to prevent, alleviate, eliminate and / or treat type 2 diabetes
47. 47. A composition according to claim 45, characterized in that the use results in an improved glucose tolerance and / or increased sensitivity to insulin and / or reduced serum glucose levels and / or improved insulin secretion.
48. 48. A composition according to claim 45, characterized in that it is used in reducing the influx of cholesterol and / or triglycerides in the arterial wall in a diabetic subject
49. 49. A composition according to claim 45, characterized in that it is used in prevent, alleviate, eliminate and / or treat a cardiovascular disease in a diabetic subject
50. 50. A composition according to claim 49, characterized in that the cardiovascular disease is selected from the group that co nsiste of hypertrigliceridemia, hypercholesterolemia, hypertension, hyperglycemia, hyperinsulinemia, arteriosclerosis, atherosclerosis, arteriolosclerosis, angina, thrombosis and myocardial infarction.
51. 51. A pharmaceutical preparation characterized in that it comprises a composition according to any of claims 1 to 50.
52. 52. The use of the composition according to any of claims 1 to 50, characterized by the manufacture of a medicament for treating a subject. who suffers from type 2 diabetes and / or the metabolic syndrome.
53. 53. The use according to claim 52, characterized in that the medicament is effective in improving glucose tolerance and / or increasing insulin sensitivity and / or decreasing serum glucose levels and / or improving insulin secretion.
54. 54. The use of a composition according to any one of claims 1 to 50, characterized in that the manufacture of a medicament for treating a cardiovascular disease in a diabetic subject.
55. 55. The use according to claim 54, characterized in that the medicament is effective in decreasing total serum cholesterol levels and / or serum LDL-cholesterol levels and / or serum triglyceride levels and / or homocysteine levels in serum and / or effective in increasing the proportion of HDL / LDL-cholesterol in serum and / or HDL-cholesterol levels in a subject.
56. 56. The use of a composition according to any of claims 1 to 50, characterized by the manufacture of a nutritional preparation to decrease ^^ and ^^^ serum glucose levels and / or total serum cholesterol levels and / or serum LDL-cholesterol levels and / or serum triglyceride levels and / or serum homocysteine levels and / or increase the proportion of HDL / L.DL-cholesterol and / or HDL-cholesterol levels in serum of a diabetic subject.
57. 57. The use according to claim 56, characterized in that the nutritional preparation is in the form of a dietary supplement.
58. 58. The use of a composition according to any of claims 1 to 50, characterized as being a partial or total diet for an overweight subject suffering from a diabetic condition.
59. 59. A method for preventing and / or treating type 2 diabetes therapy in a human or animal body, the method characterized in that it comprises administration to the human or animal body of a composition according to any of claims 1 to 50 in an effective amount. for decreasing serum glucose levels and improving glucose tolerance and / or increasing insulin sensitivity and / or relieving impaired glucose tolerance and / or improving insulin secretion and / or decreasing total serum cholesterol levels and / or LDL levels -cholesterol in serum and / or decrease serum triglyceride levels and / or serum homocysteine levels and / or reduce the influx of cholesterol and / or triglycerides in the arterial wall and / or reduce the amount of oxidized LDL-cholesterol present in the arterial wall and / or effective in increasing the proportion of HDL / LDL-cholesterol in serum and / or HDL-cholesterol levels and / or reduce or eliminate the formation of fatty furrow and / or prevent, reduce or eliminate forming fibrous plaque and / or preventing, reducing or eliminating complicated formation of injury and / or preventing, reducing or eliminating the risk of a subject contracting angina and / or preventing, reducing or eliminating the risk of a subject contracting a myocardial infarction and / or preventing, treating, treating prophylactically, alleviating and / or eliminating hypertension and / or hyperglycemia and / or hyperinsulinemia and / or hypercholesterolemia and / or hypertriglyceridemia and / or arteriosclerosis and / or atherosclerosis and / or arteriolosclerosis in a diabetic subject.
60. 60. A method for preventing and / or treating by therapy the metabolic syndrome in a human or animal body, the method characterized in that it comprises administration to the human or animal body of a composition according to any of claims 1 to 50 in an amount effective in decreasing serum glucose levels and improving glucose tolerance and / or increasing insulin sensitivity and / or relieving impaired glucose tolerance and / or improving insulin secretion and / or decreasing serum total cholesterol levels and / or LDL-cholesterol in serum and / or decrease serum triglyceride levels and / or serum homocysteine levels and / or reduce the influx of cholesterol and / or triglycerides in the arterial wall and / or reduce or eliminate fat groove formation and / or preventing, reducing or eliminating fibrous plaque formation and / or preventing, reducing or eliminating complicated lesion formation and / or preventing, reducing or eliminating a subject's risk of contracting angina. chest and / or preventing, reducing or eliminating the risk of a subject contracting a myocardial infarction.