RU2465787C1 - Composition promoting regulation of total cholesterol and ldl cholesterol and/or weight loss and/or thermogenesis - Google Patents

Abstract

FIELD: food industry.

SUBSTANCE: invention relates to food industry, in particular, to food compositions based on natural extracts. The composition includes green tea extract in an amount of 200 mg - 300 mg, guarana extract in an amount of 160 mg - 260 mg, mate grass extract in an amount of 100 mg - 300 mg and conjugated linoleic acid in an amount of 700 mg - 3400 mg.

EFFECT: invention allows to produce a composition that (due to simultaneous presence of all the four components in the specified quantity) promotes regulation of total cholesterol and LDL cholesterol content and/or weight loss and/or thermogenesis as well as ensures carefully controlled caffeine content in the composition.

33 cl, 5 dwg, 2 tbl, 1 ex

Description

FIELD OF THE INVENTION

The present invention relates to food compositions of natural origin, in particular to a composition based on natural extracts, which helps to regulate the content of total cholesterol and low density lipoproteins, contributes to weight loss and / or thermogenesis in humans.

BACKGROUND OF THE INVENTION

Obesity can be defined as the presence of excess adipose tissue, which is manifested by weight gain. An increase in fat accumulation is a consequence of excessive energy absorption (excess nutrition) and a decrease in absorption of these nutrients (decreased physical activity).

In practice, it is generally accepted that body weight is excessive if the body weight exceeds the “desired weight”, while obesity is considered to be excess of the “desired weight” by 20% or more (Council on Scientific Affairs, 1988, Treatment of Obesity in Adults. JAMA 260, 2547-48). The desired weight of a person can be determined according to the tables of growth and weight indicators Metropolitan Height and Weight Tables (Council on Scientific Affairs, 1988, Treatment of Obesity in Adults. JAMA 260, 2547-48) by the midpoint of the range for people of average physique.

Obesity can be classified according to the percentage of fat as mild (20-30%), moderate (30-60%) or severe (equal to 60% or more) or using the body mass index (BMI, BMI), which is calculated by dividing the person’s weight in kilograms of his height in meters, squared, while a result below 18.5 is considered low weight, from 18.5 to 25 is considered weight that meets the norm, 25 to 30 is considered overweight, and an indicator above 30 indicates obesity.

Obesity is accompanied by a number of health conditions. Obesity can adversely affect the functions of the heart and lungs, disrupt the endocrine system, can cause emotional problems and even cause the so-called metabolic syndrome, which is a combination of metabolic risk factors that increase the risk of diabetes, coronary artery disease, apoplexy and peripheral vascular disease , and, in general, is characterized by abdominal obesity, dyslipidemia (increased triglycerides), high blood pressure, intolerance Strongly glucose and hypercoagulation (tendency to excess blood clots).

High blood pressure, glucose intolerance, and non-insulin-dependent diabetes mellitus and hypercholesterolemia in overweight people are more common than in people with normal weight. Obesity can contribute to morbidity and mortality in people who suffer, for example, high blood pressure, heart attack, type II diabetes, certain cancers, gall bladder diseases and coronary heart disease. It is known that moderate to severe obesity increases mortality. Colon cancer and colorectal cancer are diseases that often occur in obese men, and obese women often suffer from cancer of the uterus or gall bladder cancer. It is noted that due to the increase in excess weight, there is an increase in psychological and social problems.

Obesity is due to numerous and complex causes, while their relationship is not fully known. Obesity can be the result of a lifestyle, namely the lack of physical activity and indiscriminate consumption of food and / or the result of a genetic predisposition of people to obesity. In general, it is believed that genetic factors play an important role in determining the completeness and obesity of a person.

The basic principle for treating obesity or overweight is to establish negative energy metabolism. Negative energy metabolism can be achieved mainly through three different treatments or a combination thereof.

First, effective treatment consists in reducing the intake or intake of calories, namely the absorption of food. This is possible mainly through dietary treatment and, in some cases, with a number of drugs. Dietary treatment should consist of a weight loss diet, as well as a maintenance diet. After successful weight loss, you need to gradually increase the number of calories consumed until the weight is stabilized, with a diet rich in nutrients and acceptable to the patient. The importance of a long-term diet is confirmed by the fact that only 10 to 20% of patients are able to maintain weight after it is reduced.

Secondly, an increase in physical activity will lead to an increase in energy expenditure and, as a result, will contribute to negative energy metabolism. However, to achieve significant weight loss requires several hours of daily exercise. Thus, physical activity in itself plays a small role in the treatment of obesity, although it is a very important addition to other types of treatment. Physical activity can also contribute to energy expenditure after dietary treatment, which includes calorie restriction.

Thirdly, medications can be used to treat obesity, alone or in combination with diet and / or increased physical activity. The drugs used to treat obesity can be drugs that reduce appetite and / or have a thermogenic effect. At the same time, a partial coincidence of these two categories is often observed. The effect of drugs that reduce appetite is mainly due to a decrease in calorie intake or absorption. A decrease in food intake is a consequence of the action of the drug in the mediator systems of the brain, which are involved in the regulation of appetite. It is believed that the effects of these drugs are associated with the intermediate activity of the hypothalamus in several places. The action can be carried out by means of an adrenergic, dopaminergic or serotonergic pathway or by a combination of these pathways. Regardless of the mechanism, the end result is a stimulation of the saturation center and, possibly, a simultaneous decrease in the activity of the food center, resulting in decreased appetite. Examples of known appetite suppressants are, for example, ephedrine, phenylpropanolamine, amphetamine and fenfluramine. It should be noted that ephedrine-based mixtures as drugs for controlling overweight and obesity are not allowed due to their negative health effects (high blood pressure and risk of myocardial infarction).

Thermogenic drugs are currently widely used to treat obesity, since they have potential therapeutic value, and in recent years there has been an increasing interest in the search for new thermogenic compounds. The problem is mainly related to the well-known assumption that obesity can be predetermined genetically. The genetic defect responsible for the likelihood of developing obesity refers to a thermogenic defect (that is, a defect in the metabolic system) in obese people (Dulloo, A. and DSMiller, 1989, Ephedrine, caffeine and aspirin: "Over-the-counter" drugs that interact to stimulate thermogenesis in the obese. Nutrition 5, 7-9). If the nature of the thermogenic defect is absolutely clear, however, there is known evidence that indicates impaired activity of the sympathoadrenal system (Astrup, A.V., 1989, Treatment of obesity with thermogenic agents, Nutrition 5, p.70). The authors of Dulloo and Miller suggest that the thermogenic defect in obese people relates more to a reduced release of norepinephrine than to a lack of sensitivity to the neurotransmitter. Thus, drugs that mimic the activity of the sympathetic nervous system and increase the level of metabolism, offer significant therapeutic opportunities for the treatment of obesity.

Thermogenic medicine can be defined as a medicine that can increase the level of metabolism, namely, increase energy consumption. Among the known thermogenic drugs, mention may be made, for example, of ephedrine, epinephrine, norepinephrine (Astrup A., 1986, Thermogenesis in human brown adipose tissue and skeletal muscle induced by sympatomimetic stimulation. Acta Endocrinol. 112, suppl. 278, 1-32), isoproterenol , phenylpropanolamine and caffeine (Hollands, MA, JRSArch and MACowthorne, 1981, A simple apparatus for comparative measurements of energy expenditure in human subjects: The thermic effect of caffeine. Am. J. Cin. Nutr. 34, 2291-2294) .

Human obesity can also be treated with orlistat (Orlistat®, see US Pat. No. 4,598,089), which has the commercial name Xenical®, from Roche®, also known as tetrahydrolipostatin. Its main function is to prevent the absorption of fat in the human diet, and thus the amount of calories consumed is reduced. Orlistat® acts by inhibiting pancreatic lipase, an enzyme that breaks down intestinal triglycerides. Without this enzyme, the consumed triglycerides do not hydrolyze to fatty acids that can be absorbed, and the triglycerides are excreted without being digested. Only a small amount of orlistat® is exposed to systemic absorption; its main effect after taking an oral dose is local lipase inhibition within the gastrointestinal tract. The main method of elimination is excretion with feces.

Thermogenic additives or compositions based on combinations of various herbs and extracts that have an effective effect are currently available. Examples of existing thermogenic compositions are described in the following patent documents.

In published patent application US-2005/0130933 A1, Ira Jakobs, Paul T. Gardiner and Michael Molina describe a weight loss supplement that contains a satiety promoting ingredient and which contains a mixture of dietary fiber including glucomannan, resin and thermogenic ingredient selected from the group consisting of caffeine, catechin polyphenol and combinations thereof.

In published patent application US-2004/0202732 A1, William Stewart Brown, Tara Nadine Stubensey, Alan Christopher Logan and Alicja Wojewnik Smith describe a synergistic composition of green tea and, preferably, green tea extract, for example, epigallocatechin gallate (EGCG) and linoleic combined acid, which contributes to weight loss in people.

In published patent application US-2003/0082168 A1, Inna Yegorova describes a composition that facilitates weight loss, inhibits carbohydrate absorption, improves lipolysis and modulates glucose metabolism in humans. The composition contains wheat alpha-amylase, conjugated linoleic acid, lipotropic vitamins and green tea.

In published patent application WO-2005/067952 A1, Marcin Krotkiewski describes a formulation for the treatment of obesity and associated metabolic syndrome; the recipe combines green tea extract that contains epigallocatechin gallate (EGCG), Coleus forskholii extract, Betula alba extract and guarana extract or green tea extract.

In published Mexican patent application MX-P01007191 A, Max Rombi describes a composition for the therapeutic and prophylactic treatment of obesity, which includes an extract of green tea rich in catechins, in particular containing from 20% to 50% by volume catechins, which are epigallocatechin gallate ( EGCG).

US Pat. No. 6,932,987 B1 to Jose A. Díaz and Eduardo M. Naranjo describes a tablet-shaped chemical composition that improves metabolism, which composition contains about 100 mg of L-carnitine, about 50 mg of conjugated linoleic acid, a certain amount of ginger extract , approximately 50 mg of green tea extract, approximately 50 mg of Citrus aurantium and approximately 25 mg of capsaicin.

US-6,565,847 B1 to Wayne F. Gorsek describes a weight loss formulation that contains green tea extract, hydroxycitric acid, thermogenic herbs, glucomannan, chromium, and probiotic. The recipe increases the basal metabolism, suppresses appetite and promotes the utilization of fat without causing side effects on the cardiovascular system.

Obviously, the compositions described above can only be used to reduce weight and increase thermogenesis, while there is no careful control of caffeine content in them in accordance with sanitary requirements for use, as well as in accordance with other health indicators that accompany obesity and play an important role in some pathological conditions in humans. Examples of these other indicators can be a violation of cholesterol metabolism, a balance of lipoproteins responsible for cholesterol transport, a violation of blood pressure, etc.

It is known that deposits of cholesterol in the vascular system are considered to be the cause of various pathological conditions, including coronary heart disease.

A person receives cholesterol in two ways, exogenously directly from food and endogenously, through synthesis in the cells of the body from acetyl-coenzyme A (acetyl-CoA).

Cholesterol biosynthesis takes place in the endoplasmic reticulum (smooth) in virtually all animal cells. The main steps in the synthesis of cholesterol are: the conversion of acetyl-CoA to mevalonate; the conversion of mevalonate to squalene using sequential transfer reactions of prenyl groups; converting squalene to lanosterol; and converting lanosterol to cholesterol using another 21 sequential enzyme-catalyzed reactions.

It is now known that cholesterol is transported into the blood in the form of complex particles consisting of cholesterol esters plus triglycerides in the center, and the outer part of the particles consists mainly of phospholipids and various types of protein, which are considered specific receptors. For example, cholesterol is transported to places of accumulation in blood vessels in the form of low density lipoprotein cholesterol (LDL) and returned from such places of accumulation in the form of high density lipoprotein cholesterol (HDL).

Currently, the causative role of LDL cholesterol in the pathological state of atherosclerosis is widely recognized. Thus, the continued presence of high LDL cholesterol levels that exceed the recommended values increases the risk of cardiovascular events (mainly acute myocardial infarction). Interestingly, HDL cholesterol plays a role in protecting the cardiovascular system. Thus, cholesterol has a dual and complex effect on the physiopathology of atherosclerosis, therefore it is obvious that the assessment of cardiovascular risk based on total plasma cholesterol alone is insufficient.

However, in view of the above, clinically determined plasma total cholesterol levels (the amount of cholesterol present in all classes of lipoproteins) recommended by the American Society of Cardiology are as follows:

- cholesterinemia below 200 mg / dl (milligram per deciliter): the desired concentration for the general population, usually corresponding to a low risk of cardiovascular disease;

- cholesterolemia from 200 to 239 mg / dl: a state of moderate risk for the general population, but increased for people with other risk factors such as diabetes mellitus;

- high cholesterolemia 240 mg / dl: can determine a high risk of cardiovascular disease, and it is recommended to start a lifestyle change, especially in relation to diet and exercise.

Strictly speaking, the desired level of LDL cholesterol must be determined clinically for each person, depending on their individual risk of cardiovascular disease, which is determined by the presence of different risk factors, among which are: age and gender, family history, smoking, high blood pressure, HDL cholesterol.

People with a high risk of cardiovascular disease, namely with a probability of more than 20% of a major cardiovascular event or death over 10 years, include, for example, patients with diabetes or people who have a history of one of these events. The current recommendation for them is to maintain LDL cholesterol below 100 mg / dl. Moreover, in very high-risk patients, the recommended cholesterol is 70 mg / dl of LDL or less.

Against the background of these studies, the search for therapeutic agents that regulate blood cholesterol is reduced to the discovery of compounds that will have a more selective effect; namely, agents that will effectively increase serum HDL cholesterol and / or lower LDL cholesterol. Such agents effectively change serum cholesterol levels, but at the same time they have a weak effect or do not have any effect on the regulation of the initial absorption of cholesterol, which enters the body through the intestinal wall with food.

In the cells of the intestinal mucosa, food cholesterol is absorbed as free cholesterol, which must be esterified by the action of the enzyme acetyl-CoA: cholesterol acyltransferase (ACAT), before it can be packaged in chylomicrons, which are later released into the bloodstream. Thus, therapeutic agents that effectively inhibit the action of ACAT prevent the absorption of cholesterol from food or the reabsorption of cholesterol previously released in the intestine through the body's own regulatory activity from the intestines into the bloodstream.

Given the above, there is a need for a composition based on natural plant extracts with synergistic properties and with an adjustable caffeine content, which will help regulate total cholesterol and LDL cholesterol and which, in turn, is a thermogenic composition that contributes to weight loss and thermogenesis in humans. There is also a need for food products with the aforementioned composition.

SUMMARY OF THE INVENTION

In light of the previously described and in order to achieve solutions to existing problems, the object of the present invention is a composition that promotes the regulation of total cholesterol and low density lipoproteins (LDL) in humans, and this composition includes green tea extract in an amount of from about 200 mg to about 300 mg ; guarana extract standardized for caffeine and in an amount of about 160 mg to about 260 mg; mate herb extract standardized for caffeine in an amount of from about 100 mg to about 300 mg; and conjugated linoleic acid in an amount of from about 700 mg to about 3400 mg.

Another object of the present invention is a composition that promotes weight loss in humans, said composition comprising an extract of green tea in an amount of from about 200 mg to about 300 mg; Guarana extract in an amount of about 160 mg to about 260 mg; mate herb extract in an amount of about 100 mg to about 300 mg; and conjugated linoleic acid in an amount of from about 700 mg to about 3400 mg.

Also an object of the invention is a composition that promotes thermogenesis in humans, said composition comprising an extract of green tea in an amount of about 200 mg to about 300 mg; Guarana extract in an amount of about 160 mg to about 260 mg; mate herb extract in an amount of about 100 mg to about 300 mg; and conjugated linoleic acid in an amount of from about 700 mg to about 3400 mg.

Another object of the invention is the use of a composition that contains green tea extract in an amount of from about 200 mg to about 300 mg; Guarana extract in an amount of about 160 mg to about 260 mg; mate herb extract in an amount of about 100 mg to about 300 mg; and conjugated linoleic acid in an amount of from about 700 mg to about 3400 mg, to produce a weight loss food product, regulation of low density lipoprotein cholesterol (LDL cholesterol) and / or human thermogenesis.

Additionally, in each of the objects of the invention, green tea extract contains at least 50% epigallocatechin gallate (EGCG), and the content of conjugated linoleic acid (CLA) is standardized to at least 50% trans-10, cis-12-CLA (10-12 KLK) and 50% cis-9, trans-11-KLK (9-11 KLK).

Also in each of the objects of the invention, green tea extract contains caffeine in an amount of about 10 mg to about 15 mg, guarana extract contains caffeine in an amount of about 35 mg to about 58 mg, and mate herb extract contains caffeine in an amount of about 9 mg to about 27 mg

BRIEF DESCRIPTION OF THE FIGURES

The following paragraphs of the present invention describe its characteristic details together with the accompanying drawings, which are given to define the invention, but not to limit its scope.

The figure 1 presents a chart of total weight loss after 12 weeks of observation of groups of people involved in the study according to a variant embodiment of the invention.

The figure 2 presents a chart of total weight loss after 12 weeks of observation of groups of people involved in the study, who consumed yogurt with additives, according to a variant embodiment of the invention.

The figure 3 presents a chart of total weight loss in accordance with figure 1, showing after 12 weeks of observation the physique of people in groups involved in the study in accordance with an embodiment of the invention.

The figure 4 presents a diagram of the content of cholesterol of low density lipoprotein (LDL cholesterol) after 12 weeks of observation of people who used yogurt with additives in the groups involved in the study according to a variant embodiment of the invention.

The figure 5 presents a diagram of the regulation of total cholesterol after 12 weeks of observation of people who consumed yogurt with additives in the groups involved in the study according to a variant embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The following paragraphs of the present invention provide its characteristic details for the purpose of defining the invention, but not limiting its scope.

In a composition that promotes the regulation of total cholesterol and low density lipoproteins, weight loss and / or thermogenesis in humans, according to the invention, there are components, which, in turn, can consist of many components.

The components are described separately below, their description is optionally given in order of importance.

GREEN TEA EXTRACT

This is a traditional herbal tea known as Camellia sinensis. It contains many phytoactive substances, and substances with a large effect of reducing fat are polyphenols, in particular polyphenol, known as EGCG. Green tea also contains some caffeine, but much less than coffee. Green tea is also rich in important minerals such as selenium or manganese.

Studies on the effects of green tea include exploring the mechanisms by which catechins can help reduce serum lipids. It is assumed that the most active catechin is EGCG, which has a noticeable antioxidant effect, which can obviously exceed the effect of vitamins C and E, and also has thermogenic properties and increased fat utilization for energy. Among its properties, LDL modulation (Christina A. Bursill and Paul D. Roach, Modulation of Cholesterol Metabolism by the Green Tea Polyphenol (-) - Epigallocatechin Gallate in Cultured Human Liver (HepG2) Cells, J. Agric. Food Chem. 2006, 54, 1621-1626, and Sung I. Koo and Sang K. Noh, "Green tea as inhibitor of the intestinal absorption of lipids: potential mechanism for its lipid-lowering effect", Journal of Nutritional Biochemistry 18 (2007) 179-183 )

Green tea and, therefore, the catechins it contains increase fat utilization as a source of calories, but unlike other thermogenic substances, they do not accelerate heart rate.

GUARANA EXTRACT

Guarana extract is obtained from a plant called Paullinia Cupana, which comes from the Brazilian Amazon. It contains caffeine, theobromine, tannins, catechins, saponins and choline, as well as essential oils.

Guarana extract has a tonic effect, improves performance (mainly due to caffeine) and lipolytic effect. All these effects are due to the properties possessed by caffeine, theobromine and tannins, naturally found in guarana extract. It acts as a stimulant of the nervous system, in particular, the sympathoadrenal system, as a result of which the main metabolism increases, the state of vigor and fat oxidation increase.

Scientific studies in humans confirm the benefits of caffeine in reducing fat (Boozer CN, Nasser JA, Heymsfield SB, et al. An herbal supplement containing ma huang-guarana for weight loss: a randomized, double-blind trial. Int J Obes Relat Metab Disord, 2001; 25: 316-324) and as a factor that increases working capacity to increase the basal metabolic rate.

HERBAL EXTRACT MATE

The mate herb plant contains antioxidant polyphenols similar to tea polyphenols. Yerba mate can increase fat metabolism (Martinet A, Hostettmann K, Schutz Y, et al. Thermogenic effects of commercially available plant prepared at treating human obesity. Phytomedlcine, 2000; 6: 231-8), and in this regard, yerba mate has been proposed as a substance for weight loss.

CONJUGATED LINOIC ACID

Conjugated linoleic acid (CLA) is a specific name for the group of conjugated linoleic acid isomers (omega-6 polyunsaturated fatty acid), and it is found in nature in vegetable oils and in a higher ratio in animal products such as ruminant meat and dairy products . The two main isomers of CLA are trans-10, cis-12-CLA (10-12 CLA) and cis-9, trans-11-CLA (9-11 CLA).

Conjugated linoleic acid acts in the body at two levels: it inhibits the transport of triglycerides from the blood to adipocytes, reducing lipogenesis (the formation of adipose tissue), and facilitates the combustion of fat, generating energy in mitochondria (it promotes lipolysis).

Although CLA is often called a weight loss supplement, preliminary evidence suggests that CLA can contribute to fat loss while preserving muscle (Blankson H, Stakkestad JA, Fagertun H, et al. Conjugated linoleic acid reduces body fat mass in overweight and obese humans. J Nutr. 2000; 130: 2943-2948; Smedman A, Vessby B. Conjugated linoleic acid supplementation in humans - metabolic effects. Lipids. 2001; 36: 773-781 and Thom E. et al. Conjugated linoleic acid reduces body fat in healthy exercising humans. J Int Med Res 2001; 29: 392-396). The overall effect may be to improve physique (muscle / fat ratio) instead of losing weight.

A clinical double-blind study confirmed that CLA may be beneficial for high-density cholesterol (Noone EJ, Noone EJ, Roche HM, et al. The effect of dietary supplementation using isomeric blends of conjugated linoleic acid on lipid metabolism in healthy human subjects. Br J Nutr. 2002; 88: 243-251).

MIXTURE

The composition that promotes the regulation of total cholesterol and low density lipoproteins, weight loss and / or thermogenesis in humans, according to the invention, has components in the following amounts:

a) green tea extract from about 200 mg to about 300 mg,

b) guarana extract from about 160 mg to about 260 mg,

c) mate herb extract from about 100 mg to about 300; and

d) conjugated linoleic acid from about 700 mg to about 3400 mg.

An additional composition that helps regulate the content of total cholesterol and low density lipoproteins, weight loss and / or thermogenesis in humans, according to the invention, contains:

e) an ingredient for satisfying appetite, for example, glucomannan.

Glucomannan is a non-digestible polysaccharide (complex carbohydrate) that is extracted from a tuber of an Asian plant called Amorphophallus konjac. Glucomannan can absorb 100 times its volume in water to form a thick gel. When used together with a large amount of liquid, it has a saturation effect, which reduces the feeling of an “empty stomach” and, therefore, reduces the appetite or the need to eat. In addition, experimental and clinical studies have shown that it helps to reduce LDL cholesterol.

Other gums that can be used in the composition are xanthan gum and guar gum.

The total caffeine content in a composition that promotes weight loss, low-density lipoprotein regulation and / or thermogenesis in humans according to the present invention is within the applicable sanitary standards and is determined by the combination of the individual caffeine content in each of the components described above:

- the proportion of caffeine in the extract of green tea is in the range from about 10 mg to about 15 mg of caffeine,

- the proportion of caffeine in the guarana extract is in the range from about 35 mg to about 58 mg, and

- the proportion of caffeine in the extract of the herb mate is in the range from about 100 mg to about 300 mg.

In order to obtain food products that can contribute to the regulation of total cholesterol and low density lipoproteins, weight loss and / or thermogenesis in humans, according to the invention, the composition can be added to dairy products, juices or drinks before pasteurization or after pasteurization. The stability of the composition and its active ingredients, for example, catechins and, in particular, EGCG, will depend on the type of storage of the product and its packaging. Preferably, the product should be kept in a package that will prevent the ingress of light and oxygen and use a food composition with an acidic pH to prevent the breakdown of the active ingredients. Ideal nutritional bases of a composition for applying the composition are dairy products, juices and drinks packaged in cans with a pH level below 4.5 and preferably below 3.

Additionally, the composition of the invention may be in the form of a tablet, capsule, or as a dietary supplement.

MODES FOR CARRYING OUT THE INVENTION

The following is a description of the invention with respect to the following examples, the purpose of which is only to present a way of implementing the principles of the invention. It is assumed that the following examples are not a complete representation of the invention and are not an attempt to limit its scope.

Table 1 shows examples of compositions that contribute to the regulation of total cholesterol and low density lipoproteins, weight loss and / or thermogenesis in humans according to the invention. The table below shows the proportion of caffeine in each of the components.

Example 1

A simple, blind, controlled study of the effects on weight, BMI and physique, regulation of total cholesterol and LDL cholesterol, thermogenesis and safety in patients with obese yogurt intake, with the addition of the composition of the invention, for 12 weeks, at a variable dosage, compared to placebo.

The study was conducted at the University Hospital of the Autonomous University of Nuevo Leon in Monterrey, Nuevo Leon, Mexico.

Tasks

To assess the effects of consumption of yogurt for 12 weeks with the addition of the composition of the invention on weight, BMI and physique, regulation of total cholesterol and LDL, thermogenesis and safety in obese patients, at a low dosage (one yogurt per day).

To evaluate the effects of consumption of yogurt for 12 weeks with the addition of the composition according to the invention on weight, BMI and physique, regulation of total cholesterol and LDL, thermogenesis and safety in obese patients, at a high dosage (two yogurts per day).

Study design

The study was designed as a cohort, experimental, comparative, long-term, promising, blind, and placebo-controlled study.

3 groups of 60 patients were formed, as indicated in Table 2.

table 2 Group Patient Patients Control group I 10 type I obesity patients 10 obese patients of type II Group II low dosage 10 type I obesity patients 10 obese patients of type II High Dose Group III 10 type I obesity patients 10 obese patients of type II

7. Patient selection

The authors included 60 patients aged 18 to 60 years who gave their informed consent, of which 30 patients had type I obesity (BMI in the range from 27 to 29.9) and 30 patients had type II obesity (BMI in the range 30 to 32.5) according to the Mexican official standard for treatment (Norma Oficial Mexicana NOM) and the diagnosis of obesity.

In case women could potentially be pregnant, confirmations were received about the use of a safe method of protection.

The following were excluded from the study:

- patients with high blood pressure and / or receiving antihypertensive treatment other than diuretics,

- women who are pregnant or breastfeeding, or women planning a pregnancy,

- patients with various diseases that could affect the processing of results, or in cases in which experimental treatment could be potentially hazardous to the health of the patient, for example, patients with diseases of the gastrointestinal tract, which may have delayed absorption of the drug; with heart diseases such as arrhythmia, Wolf-Parkinson-White syndrome (WPW), and diseases caused by a cardiac disorder; severe endocrine diseases that require treatment (type I or type II diabetes); or with thyroid disease,

- patients with malignant diseases such as cancer,

- patients with psychosis or drug dependence,

- patients who, on the days before the start of the study, were treated with drugs that reliably cause weight gain,

- patients after surgical treatment of overweight,

- patients who showed pathological test results at the beginning of the study, which could indicate a potential harm to the patient’s health,

- patients who started treatment for weight loss.

However, patients with elevated serum triglycerides and serum cholesterol were not excluded.

The study completed 50 patients, 17 from control group I, 17 from group II with a low dosage and 16 from group III with a high dosage. In all cases, the termination or refusal of the study was recorded if they occurred as a result of unsuccessful treatment, adverse reactions to treatment, pathological laboratory parameters, complications of the disease, pregnancy, mismatch, unwillingness to participate in tests or other; it was found that 10 of the patients who interrupted the study did so because of a lack of desire to participate in it.

Treatment data

Control group I: one dose in the morning and one dose in the evening, 250 ml of natural yogurt (placebo) in each dose.

Group II with a low dosage: one dose of 250 ml of natural yogurt in the morning and one dose at night, 250 ml of natural yogurt with the addition of a mixture of 200 mg of green tea extract, standardized to 50% EGCG and with 10 mg of additional caffeine; 260 mg of guarana extract with additional caffeine in an amount of 57.20 mg; 100 mg of mate herb extract with additional caffeine in an amount of 9 mg and 1000 mg of conjugated linoleic acid.

Group III with a high dosage: one dose of natural yogurt 250 ml in the morning and one dose at night with the addition of a mixture of 200 mg of green tea extract, standardized to 50% EGCG and with additional caffeine in an amount of 10 mg; 260 mg of guarana extract with additional caffeine in an amount of 57.20 mg; 100 mg of mate herb extract with additional caffeine in an amount of 9 mg and 1000 mg of conjugated linoleic acid.

During the study, other treatments for overweight or obesity were not allowed. Drugs that did not interact with the treatment that was the aim of the study were allowed.

Study plan .

Before starting the study, patients were informed about it, their initial clinical condition was established, and voluntary informed consent was obtained for participation in the study.

The age, height, weight, and gender of the patients were recorded along with information about concomitant drug therapy and caffeine consumption, and patients received dietary instructions. The established diet recommended for consumption was fixed as 1500 kcal.

At the first visit, patients were randomly divided into groups according to table 2 above, with the same ratio between men and women.

Every four weeks, for 12 weeks, the doctor examined patients, carried out biochemical analyzes and body measurements to determine the effects of the research tasks, and then followed up two weeks after each visit.

Effect Evaluation

Thyroid parameters: once at the beginning of the study, each patient was quantified by thyrotropin (TSH), thyroxine (T4), total triiodothyronine (T3) and free thyroxine (FT4) in serum and plasma using in vitro electrochemiluminescent immunoassay (ECLIA), with Elecsys reagents, using Roche® Elecsys 1010/2010 automated analyzers, free T3 was determined by radioimmunoassay.

Body Weight: Patients were weighed on a balance at each visit. We used scales from the Bod Pod® Body Composition Tracking System from Life Measurements Inc. The scales were calibrated every week.

Main energy expenditure: patients were tested by indirect calorimetry at each visit. CardiCoach® equipment from Korr Medical Instruments was used.

Build: Fat-free body weight (FFBM) and fat mass (FM) were measured, with FFBM considered the integrated mass of all body components, excluding fat, and FM was calculated as the amount of fat that is stored in the body as an energy reserve, for each patient, the definition physique was performed for 12 weeks using Bod Pod® Body Composition Tracking System equipment from Life Measurements Inc., in addition, local body fat mass, fat free mass, total water were quantified, and muscle mass was estimated based on data obtained nnyh dvuhemissionnoy by X-ray absorptiometry (DXA) (DXA) and bioelectrical impedance analysis (AIB), all studies were performed using Tanita® equipment.

Regulation of total cholesterol and LDL cholesterol: the effect of treatment on the content of total cholesterol and LDL cholesterol in patients was determined by blood tests in serum and plasma.

Results

According to figure 1 and 2 after 12 weeks of the study, the reduction in body weight in patients was on average 2.07 kg in control group I, 2.69 kg in group II with a low dosage and 1.35 kg in group III with a high dosage. With regard to physique (see figure 3), an average increase in control group I of 0.72 kg of body weight without fat (FFBM) and a decrease of 2.79 kg of body weight of fat (FM) were observed on average in control group I. In group II with a low dosage, an increase of 0.90 kg of FFBM and a decrease of 3.59 kg of FM, while in group III with a high dosage, an increase of FFBM of 0.60 kg and a decrease of FM of 1.95 kg were noted. Based on this, a difference was noted between the groups that received the most benefit for weight loss in group II with a low dosage.

At the same time, an increase in mean plasma LDL cholesterol of 16.40 mg / dL in control group I and 1.65 mg / dL in group II with a low dosage was observed, while a decrease of 4.9 mg / dl (see figure 4). With respect to total plasma cholesterol, an average increase of 9 mg / dl was observed in control group I and a decrease of 11.6 mg / dl in group II with a low dosage and 8.5 mg / dl in group III with a high dosage (see figure 5).

Based on the embodiments described above, it has been found that changes in the circumstances of the described embodiments, as well as alternative circumstances for the embodiments, will be considered apparent to one skilled in the art upon study of the present description. Thus, it is believed that the claims cover such modifications and alternatives that are included in the scope of the present invention or its equivalents.

Claims (33)

1. A composition that promotes the regulation of total cholesterol and low density lipoprotein (LDL) in humans, containing green tea extract and conjugated linoleic acid, characterized in that the composition further comprises:
guarana extract in an amount of 160 mg to 260 mg; and
mate herb extract in an amount of 100 mg to 300 mg; and where the content of green tea extract in the composition is from 200 mg to 300 mg; and the content of conjugated linoleic acid in the composition is from 700 mg to 3400 mg. 2. The composition according to claim 1, characterized in that the green tea extract contains caffeine in an amount of from 10 mg to 15 mg. 3. The composition according to claim 1, characterized in that the guarana extract contains caffeine in an amount of from 35 mg to 58 mg. 4. The composition according to claim 1, characterized in that the mate herb extract contains caffeine in an amount of from 9 mg to 27 mg. 5. The composition according to claim 1, characterized in that it contains epigallocatechin gallate (EGCG) in an amount of at least 80 mg. 6. The composition according to claim 1, characterized in that the green tea extract is standardized for at least 50% epigallocatechin gallate (EGCG). 7. The composition according to claim 1, characterized in that the conjugated linoleic acid is standardized for at least 50% trans-10, cis-12-CLA (10-12 CLA) and 50% cis-9, trans-11-CLA (9-11 CLK). 8. The composition according to claim 1, characterized in that it additionally contains an ingredient for satisfying appetite, selected from the group consisting of glucomannan, xanthan gum, guar gum and combinations thereof. 9. A composition that promotes weight loss in humans, containing green tea extract and conjugated linoleic acid, characterized in that the composition further comprises:
guarana extract in an amount of 160 mg to 260 mg; and mate herb extract in an amount of from 100 mg to 300 mg; and where the content of green tea extract in the composition is from 200 mg to 300 mg; and the content of conjugated linoleic acid in the composition is from 700 mg to 3400 mg. 10. The composition according to claim 9, characterized in that the green tea extract contains caffeine in an amount of from 10 mg to 15 mg. 11. The composition according to claim 9, characterized in that the guarana extract contains caffeine in an amount of from 35 mg to 58 mg. 12. The composition according to claim 9, characterized in that the mate herb extract contains caffeine in an amount of from 9 mg to 27 mg. 13. The composition according to claim 9, characterized in that it further comprises epigallocatechin gallate (EGCG) in an amount of at least 80 mg. 14. The composition according to claim 9, characterized in that the green tea extract is standardized for at least 50% epigallocatechin gallate (EGCG). 15. The composition according to claim 9, characterized in that the conjugated linoleic acid is standardized for at least 50% trans-10, cis-12-CLA (10-12 CLA) and 50% cis-9, trans-11-CLA (9-11 CLK). 16. The composition according to claim 9, characterized in that it further comprises an ingredient for satisfying appetite, selected from the group consisting of glucomannan, xanthan gum, guar gum and combinations thereof. 17. A composition that promotes thermogenesis in humans, containing green tea extract and conjugated linoleic acid, characterized in that the composition further comprises:
guarana extract in an amount of 160 mg to 260 mg; and
mate herb extract in an amount of 100 mg to 300 mg; and where the content of green tea extract in the composition is from 200 mg to 300 mg; and the content of conjugated linoleic acid in the composition is from 700 mg to 3400 mg. 18. The composition according to 17, characterized in that the green tea extract contains caffeine in an amount of from 10 mg to 15 mg. 19. The composition according to 17, characterized in that the guarana extract contains caffeine in an amount of from 35 mg to 58 mg. 20. The composition according to 17, characterized in that the mate herb extract contains caffeine in an amount of from 9 mg to 27 mg. 21. The composition according to 17, characterized in that it further comprises epigallocatechin gallate (EGCG) in an amount of at least 80 mg. 22. The composition according to 17, characterized in that the green tea extract is standardized for at least 50% epigallocatechin gallate (EGCG) content. 23. The composition according to p. 17, characterized in that the conjugated linoleic acid is standardized for at least 50% trans-10, cis-12-CLA (10-12 CLA) and 50% cis-9, trans-11-CLA (9-11 CLK). 24. The composition according to 17, characterized in that it further comprises an ingredient for satisfying appetite, selected from the group consisting of glucomannan, xanthan gum, guar gum, and combinations thereof. 25. The use of a composition containing green tea extract in an amount of 200 mg to 300 mg, guarana extract in an amount of 160 mg to 260 mg, mate herb extract in an amount of 100 mg to 300 mg and conjugated linoleic acid in an amount of 700 mg to 3400 mg, for the manufacture of a food product that helps regulate total cholesterol and low density lipoproteins (LDL), weight loss and / or thermogenesis in humans. 26. The application of claim 25, wherein the green tea extract contains caffeine in an amount of 10 mg to 15 mg. 27. The application of claim 25, wherein the guarana extract contains caffeine in an amount of from 35 mg to 58 mg. 28. The use of claim 25, wherein the mate herb extract contains caffeine in an amount of 9 mg to 27 mg. 29. The application of claim 25, wherein the composition further comprises epigallocatechin gallate (EGCG) in an amount of at least 80 mg. 30. The application of claim 25, wherein the green tea extract is standardized for at least 50% epigallocatechin gallate (EGCG). 31. The application of claim 25, wherein the conjugated linoleic acid is standardized for at least 50% trans-10, cis-12-CLA (10-12 CLA) and 50% cis-9, trans-11-CLA (9-11 CLK). 32. The application of claim 25, wherein the composition further comprises an appetite-satisfying ingredient selected from the group consisting of glucomannan, xanthan gum, guar gum, and combinations thereof. 33. The application of claim 25, wherein the food product is selected from the group consisting of dairy products, juices and drinks with a pH level of less than 4.5.

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