WO2016029210A1 - Cholesterol lowering nutriceutical comprising raw buckwheat and cultured dairy drink - Google Patents
Cholesterol lowering nutriceutical comprising raw buckwheat and cultured dairy drink Download PDFInfo
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- WO2016029210A1 WO2016029210A1 PCT/US2015/046560 US2015046560W WO2016029210A1 WO 2016029210 A1 WO2016029210 A1 WO 2016029210A1 US 2015046560 W US2015046560 W US 2015046560W WO 2016029210 A1 WO2016029210 A1 WO 2016029210A1
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- cultured dairy
- buckwheat
- dairy drink
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- raw
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- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- 235000015192 vegetable juice Nutrition 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
- A23C9/00—Milk preparations; Milk powder or milk powder preparations
- A23C9/12—Fermented milk preparations; Treatment using microorganisms or enzymes
- A23C9/127—Fermented milk preparations; Treatment using microorganisms or enzymes using microorganisms of the genus lactobacteriaceae and other microorganisms or enzymes, e.g. kefir, koumiss
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
- A23C9/00—Milk preparations; Milk powder or milk powder preparations
- A23C9/12—Fermented milk preparations; Treatment using microorganisms or enzymes
- A23C9/13—Fermented milk preparations; Treatment using microorganisms or enzymes using additives
- A23C9/1315—Non-milk proteins or fats; Seeds, pulses, cereals or soja; Fatty acids, phospholipids, mono- or diglycerides or derivatives therefrom; Egg products
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present invention relates to the field of nutraceuticals and provides a composition comprising raw buckwheat and a cultured dairy drink, which lowers LDL (bad) cholesterol and triglyceride levels in the subject consuming the composition.
- statins Although the American Heart Association reports that cholesterol levels have gone down among Americans, it is believed because there has been an increase in consumption of statins. For example, is 1988, only 3-4 percent of Americans were taking statins but now the number is 15.5 percent. For men and women over the age of 50, the number of patients taking statins has gone up to 35%.
- statins can carry the risk of side effects.
- the most common statin side effects include: headache, difficulty sleeping, flushing of the skin, muscle aches, tenderness, or weakness (myalgia), drowsiness, dizziness, nausea or vomiting, abdominal cramping or pain, bloating or gas, diarrhea, constipation and rash.
- Statins also carry warnings that memory loss, mental confusion, high blood sugar, and type 2 diabetes are possible side effects.
- Cholesterol lowering drugs exist, however they have been widely known to cause severe side effects. These include: muscle problems, polyneuropathy (nerve damage in the hands and feet, and rhabdomyolysis (a serious degenerative muscle tissue condition), anemia, acidosis, sexual dysfunction, immune depression, pancreas or liver dysfunction, including a potential increase in liver enzymes, cataracts, cognitive problems and memory loss, and blood glucose elevation, etc.
- Obesity is a leading preventable cause of death worldwide, which has an increasing prevalence in adults and children. It is currently viewed as one of the most serious public health issues of the 21st century. Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy and/or increased health problems. Obesity increases the likelihood of various diseases, particularly heart disease, type 2 diabetes, obstructive sleep apnea, certain types of cancer and osteoarthritis.
- Obesity is most commonly caused by a combination of excessive food energy intake, lack of physical activity, and genetic susceptibility. Anti-obesity drugs exist; however, those may have serious/negative side effects. In severe cases surgery is performed or an intra-gastric balloon is placed to reduce stomach volume and/or bowel length, leading to earlier satiation and reduced ability to absorb nutrients from food. Medication and surgery are very expensive methods to treat obesity, and are usually utilized at an advanced stage of this condition.
- BMI body-mass index
- Diet therapy is the most basic, the least invasive and therefore the most optimal method for treating obesity and excessive weight.
- some of the current diets are very rigorous and time consuming. It is essential to take that into account when suggesting a diet.
- the more natural the diet ingredients, the better they are digested and processed by the body There thus remains a need for a suitable nutritional composition that can be consumed to lower LDL cholesterol and triglycerides from the blood stream.
- the present invention provides a composition for oral ingestion for lowering LDL cholesterol and triglycerides in a subject.
- the composition comprises, or consists essentially of, a mixture of raw buckwheat and cultured dairy drink.
- the raw buckwheat is preferably buckwheat flour and the cultured dairy drink comprises a lactic acid microorganism and a yeast.
- the cultured dairy drink is kefir.
- the mixture of raw buckwheat flour and cultured dairy drink has been mixed and allowed to sit for about 8 hours at room temperature before consumption.
- the present invention also provides a kit comprising raw buckwheat and cultured dairy drink and instructions for mixing the raw buckwheat and cultured dairy drink.
- a method of manufacturing a nutraceutical combining raw buckwheat and cultured dairy drink is another embodiment of the invention.
- the method involves processing the raw buckwheat into a flour, powder or fine grain by extrusion and also involves sterilizing the buckwheat with heat, preparing the cultured dairy drink; and combining the buckwheat and cultured dairy drink.
- Another embodiment of the invention provides a method of lowering serum LDL cholesterol and/or triglycerides in a subject.
- the method involves orally administering a mixture of raw buckwheat and cultured dairy drink for a period of 2-8 weeks.
- the mixture comprises 1 oz. of raw buckwheat and 4 oz. cultured dairy drink.
- compositions for oral ingestion that is useful for lowering LDL cholesterol and triglycerides in the serum of a subject.
- compositions may improve digestion and may improve the digestion of lactose.
- compositions of the invention comprise a mixture of raw buckwheat and a cultured dairy drink.
- the composition may also consist essentially of a mixture of raw buckwheat and cultured dairy drink, meaning that the compositions may include additives for taste and preservation, coloring, stabiliers, etc., but does not contain other "active" ingredients for reducing LDL cholesterol and triglycerides in the serum of a subject.
- compositions may further include other "active" ingredients such as probiotics to aid in digestion or red yeast rice extract to further assist in the reduction of overall cholesterol.
- buckwheat includes any member of the Polygonaceae family that is edible.
- the traditionally edible Polygonaceae is Fagopyrum esculentum, or buckwheat.
- Buckwheat includes any portion or fraction of edible buckwheat.
- the traditional buckwheat crop for human and animal consumption is Fagopyrum esculentum.
- Fagopyrum tataricum (Tartary buckwheat)
- buckwheat is not related to wheat, as it is not a grass. Instead, buckwheat is related to sorrel, knotweed, and rhubarb. Because its seeds are eaten, it is referred to as a pseudo-cereal.
- cultured dairy drink product means any cultured dairy drink product including any dairy drink product that has been cultured with at least one bacterium strain and one yeast strain.
- a cultured dairy drink product may include kefir.
- Kefir is a cultured dairy drink made with kefir "grains” (a yeast/bacterial fermentation starter) and has its origins in the north Caucasus Mountains. It has been traditionally prepared by inoculating cow, goat, or sheep milk with kefir grains.
- Kefir grains are a combination of lactic acid bacteria and yeasts in a matrix of proteins, lipids, and sugars, and this symbiotic matrix, forms "grains" that resemble cauliflower. For this reason, a complex and highly variable community of lactic acid bacteria and yeasts can be found in these grains although some predominant, Lactobacillus species are always present. Kefir grains contain a water-soluble polysaccharide known as kefiran, which imparts a rope-like texture and feeling in the mouth.
- the cultured dairy drink product in the composition can be kefir, or it can be another cultured dairy drink product containing a lactobacillus bacterium strain and a yeast strain.
- the cultured dairy drink product may preferably contain the lactic-acid microorganisms at a concentration of 10 7 colony-forming units (CFUs) per cubic centimeter (cm 3 ).
- the dairy drink product used to make the cultured dairy drink product can include all types of milk, including whole, skim, part skim, or any fat percentage milk (for example, but not limited to 0.1%, 1.0%, 2.0%, 2.5%, 3.2%, 4%), buttermilk, goat and sheep milk.
- the milk is non-fat or low fat milk.
- the milk can be raw milk, pasteurized or homogenized milk.
- the milk can also be dried and reconstituted milk.
- the milk can be a mixture of any of the milks.
- the cultured dairy drink product can be any of the milks described above as long as it comprises at least one type of lactic acid microorganism and at least one type of yeast.
- the cultured dairy drink product maybe freeze-dried, or otherwise prepared so it has reduced moisture content, or preserved, so that it does not need not to be refrigerated for storage.
- One of ordinarily skill in the art would know how to prepare the cultured dairy drink product in dried, partially dried or fully hydrated form to preserve the product for consumption following storage for a prescribed time.
- the cultured dairy drink product maybe ultra-heat treated or pasteurized for longer-term storage at refrigerated temperatures.
- compositions further contain yogurt in addition to the cultured dairy drink product and raw buckwheat.
- the yogurt may contain natural or added probiotics or prebiotics.
- the composition can contain flavor fillers to enhance the taste and texture of the composition.
- the composition may contain honey, agave, fruits, fruit juices, sweeteners (natural or synthetic), vegetables, vegetable juices, and natural or artificial flavors.
- the composition may also or alternatively contain fruit preparations (jams, mix of fruits/berries with sweeteners, preservatives, etc.).
- the composition can contain other additives useful to improve the taste, texture, stability, appearance, etc. of the composition, such as but not limited to, colorants, stabilizers, preservatives, and emulsifiers, etc.
- the raw buckwheat is preferably an unrefined raw buckwheat flour or powder obtained from raw buckwheat groats.
- the buckwheat flour may be organic and it may be light or dark buckwheat flour.
- the flour can be obtained by extrusion in the presence of water during a thermo-mechanical treatment. During the extrusion process, heat can be added to kill or deactivate any germs or microbes that may be present, however the heat does not cook the buckwheat and it remains raw.
- the raw buckwheat may also be in the form of, but is not limited to, a whole buckwheat grain, a refined grain, a processed or ground grain, or raw flour manufactured to be in the form of a flake or granule.
- Raw buckwheat may be processed into a flour using standard milling techniques used in obtaining flour from other grains like, wheat, spelt, amaranth, etc. In some instances, during the milling process, different screens ranging from 30 to 120 mesh are used. The majority of dark buckwheat remains on the 60-70 screens.
- the buckwheat groats may have the hull resulting in all of the hull being present in the buckwheat flour. In some instances, the buckwheat groats have the hull removed and in this case, there is no null in the flour.
- the composition of raw buckwheat and cultured dairy drink product can range in their ratios relative to each other.
- the weight ratio of raw buckwheat to cultured dairy drink may include, but is not limited to: 20/80 percent by weight ratio, 30/70 percent by weight ratio, 40/60 percent by weight ratio, 50/50 percent by weight ratio, 60/40 percent by weight ratio, 70/30 percent by weight ratio, and 80/20 percent by weight ratio.
- the invention also provides a composition of raw buckwheat and cultured dairy drink that has been mixed together and allowed to sit for about 8 hours at room temperature.
- the mixture can sit mixed together from a period of 1-8 hours, from 2-16 hours, for 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 hours. If raw extruded buckwheat flour is used, the mixture with the cultured dairy drink can be consumed right after mixing. In the extrusion process, the buckwheat is still raw, but the process cleans the buckwheat and removes any bacteria.
- the composition can be made to be any desired consistency for consumption. For example, it can be made so it is more like a drink, or it can be like a "smoothie'Vmilk shake consistency, or like a yogurt or porridge consistency.
- the composition can also be made and then dried or formed into a snack bar or even dried and then crumbed into a cereal/grain consistency.
- the present invention also provides a composition in a dosage form suitable for daily consumption or as often as needed per a desired treatment regimen.
- the treatment regimen may require a daily serving of the composition comprising two level tablespoons or 1 oz. (of raw whole buckwheat flour) and 4 oz. of low fat (1%), or non-fat cultured dairy drink.
- the daily serving comprises 5 - 100 g raw buckwheat, 10 - 200 g of raw buckwheat, or 20 - 500 g of raw buckwheat.
- the daily serving may comprise 2 oz. ( 6 -2 L) - 4 oz. (0.12 L) of cultured dairy drink, 5 oz. (0.15 L) - 10 oz. (0.24 L) of cultured dairy drink, 10 oz. (0.3 L) - 20 oz. (0.6 L) of cultured dairy drink, or 20 oz. (0.6 L) - 40 oz. (1.18 L) of cultured dairy drink.
- the composition preferably comprises optionally fruit, fruit preparations and sweeteners.
- a daily serving may also comprise 1 oz. of blueberries, 1 oz. of strawberries, and 0.5 oz. of honey.
- the composition is pasteurized.
- the present invention also provides a kit for a nutraceutical comprising raw buckwheat and cultured dairy drink.
- the kit may comprise a portion of raw buckwheat and a portion of cultured dairy drink product in separate containers/packaging.
- the raw buckwheat and cultured dairy drink product is as described above.
- the kit may further comprise fresh or dried fruit, berries, sweetener: for example, honey, agave syrup, brown sugar, white sugar, sugar substitutes, etc.
- the kit may also or alternatively contain fruit preparations (jams, mix of fruits/berries with sweeteners, preservatives, etc.).
- the kit may also comprise granola, nuts, or other ingredients as part of the nutraceutical.
- the kit may also include a packet for easily combining all of the ingredients.
- the container holding the cultured product may have a removable/reusable top, which twists or snaps to allow for mixing the cultured dairy drink product with the raw buckwheat.
- the kit may include instructions for mixing, preparing and consuming the nutraceutical.
- the kit may contain instructions on the rehydration of the cultured dairy drink product.
- the kit may contain instructions on how long to allow the combination of the raw buckwheat and the cultured dairy drink product to sit before consumptions and the kit may also contain instructions regarding how and when to consume the product.
- the present invention also provides a method of manufacturing a nutraceutical combining raw buckwheat and cultured dairy drink.
- the raw buckwheat is processed to form a powder, flour or fine grain.
- the raw buckwheat may be processed using a thermo -mechanical extrusion process involving heat to sterilize the buckwheat (but not cook it as the buckwheat is still raw) and to grind the buckwheat seeds into a powder, flour or fine grain.
- the cultured dairy drink product is preferably kefir.
- the method of manufacturing can comprise a pasteurization step for the cultured dairy drink product.
- the present invention also provides a method of lowering serum LDL cholesterol and/or serum triglycerides comprising ingesting a composition of the present invention for a time period necessary to lower serum LDL cholesterol and/or serum triglycerides.
- the method involves ingesting the composition once a day in the morning on an empty stomach (i.e. before eating breakfast) for a period of about 2 - 8 weeks. Preferably, about two hours are allowed to pass after ingestion of the composition before ingestion of other food. After 2-8 weeks have passed, the subject can have his serum tested and if the levels of LDL cholesterol or serum triglycerides have not yet been reduced to the desired level, the patient can continue on with another cycle of 2-8 weeks or with as many cycles as needed. Maintenance regimens may be taken to maintain the desired healthy levels of LDL cholesterol or serum triglycerides.
- the composition was ingested for three weeks and a lowering of LDL cholesterol was observed.
- a two week treatment occurred over the span of three weeks: one week ingesting a composition of the invention, one week off, and then one week ingesting and in this case a lowering of LDL cholesterol was observed.
- the method may further involve administration of prescribed medicines for lowering
- LDL cholesterol and/or triglycerides such as statins.
- composition consumed is as described herein but preferably contains at least 1 ounce of raw buckwheat and 4 ounces of cultured dairy drink.
- the composition produces excellent results in lowering LDL cholesterol, as well as reducing body fat, and providing the human body with the following vitamins, minerals and enzymes: manganese, tryptophan, magnesium, dietary fiber, flavonoids (i.e. rutin and quercitin), antioxidants, calcium, phosphorus, Vitamin B12, Bl, and Vitamin K, biotin, folic acid, pantothenic acid, etc.
- flavonoids i.e. rutin and quercitin
- antioxidants i.e. rutin and quercitin
- Some of the health benefits of this nutraceutical observed include: reduction in LDL cholesterol levels; reduction in triglycerides levels; reduction in sugar/fat cravings leading to weight loss; prevention of the following conditions - metabolic syndrome, morbid obesity, diabetes, heart attack, kidney failure, pancreatitis, artery hardening and atherosclerosis (which could lead to heart attack, stroke and heart disease); lowering blood pressure; promoting total cardiovascular health; improved blood sugar control and a lowered risk of diabetes; cleansing of the intestines, and contribution to an overall health of the immune system, and reduction of the risk of several kinds of cancer (i.e. colon, breast, stomach, etc.); and elimination or reduction of unhealthy food cravings by making the body more nourished and balanced thereby reducing excess body fat.
- One regimen provides a diet composition comprising two level tablespoons or loz of raw buckwheat and 4 oz. of low-fat (1 %), or non-fat cultured dairy drink.
- An alternative therapy can include daily dosages for as long as needed and tolerated.
- Patent N was born in 1952, has had high cholesterol for years, and has tried modifying his diet in every way possible: i.e. eating oatmeal, omega 3s, eating less red meat and fried foods, however his LDL cholesterol stayed constant despite these drastic measures and diets.
- Patient N consumed the product described in Example 1 for about a period of a month (with a one- week break in the middle due to travel and his lack of access to the ingredients on his location), after which his LDL cholesterol went down significantly. Most remarkably, he did not change any other elements of his diet during that time, continuing to consume red meat, fried foods, and other foods high in cholesterol. Patient N did not consume any over the counter medicines or prescription medicines for reducing cholesterol.
- Example 2 modified the recipe by adding nuts and honey to the composition where the other subjects did not add any additional flavoring agents.
Abstract
The present invention relates to a diet composition comprising raw buckwheat (Fagopyrum Esculentum or its relatives) and a cultured milk drink. The composition is useful in reducing total serum cholesterol, lower low-density lipoprotein cholesterol 5 (LDL) as well as lowering blood pressure, and promoting total cardiovascular health. It also leads to a better blood sugar control and a lowered risk of diabetes. In addition, it cleanses the intestines, and contributes to an overall health of the immune system, and reduces the risk of several kinds of cancer (i.e. colon, breast, stomach, etc.).
Description
CHOLESTEROL LOWERING NUTRICEUTICAL COMPRISING RAW BUCKWHEAT AND
CULTURED DAIRY DRINK
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional application 62/040,895, filed on
August 22, 2014, entitled CHOLESTEROL LOWERING NUTRICEUTICAL COMPRISING RAW BUCKWHEAT AND FREMENTED MILK, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION
The present invention relates to the field of nutraceuticals and provides a composition comprising raw buckwheat and a cultured dairy drink, which lowers LDL (bad) cholesterol and triglyceride levels in the subject consuming the composition. BACKGROUND OF THE INVENTION
It appears that at least a quarter of the US population aged 18 years and older have blood cholesterol levels higher than the desirable range. The Centers for Disease Control and
Prevention (CDC) reports that 71 million American adults (33.5%) have high bad cholesterol (LDL). The CDC also reports that only 1 out of every 3 adults with high LDL cholesterol has the condition under control and less than half of adults with high LDL cholesterol get treatment. Further, according to the CDC, people with high total cholesterol have approximately twice the risk of heart disease as people with optimal levels (desirable level is lower than 200 mg/dL).
Although the American Heart Association reports that cholesterol levels have gone down among Americans, it is believed because there has been an increase in consumption of statins. For example, is 1988, only 3-4 percent of Americans were taking statins but now the number is 15.5 percent. For men and women over the age of 50, the number of patients taking statins has gone up to 35%.
However, statins can carry the risk of side effects. The most common statin side effects include: headache, difficulty sleeping, flushing of the skin, muscle aches, tenderness, or weakness (myalgia), drowsiness, dizziness, nausea or vomiting, abdominal cramping or pain,
bloating or gas, diarrhea, constipation and rash. Statins also carry warnings that memory loss, mental confusion, high blood sugar, and type 2 diabetes are possible side effects. Thus, there remains a need for a healthy, natural alternative to statins for reducing LDL cholesterol.
It has been reported that the number of Americans being diagnosed with high blood pressure, high cholesterol, diabetes, depression, and cancer is rising. High blood pressure continues to be the most prevalent chronic condition in the United States, with 30.6% of adults reporting having been diagnosed with it in 2009, up 1.2 points from 2008. Increases in high blood pressure and high cholesterol are apparent across nearly all key demographic groups. For example, the rates of high blood pressure increased by more than a percentage point among women, men, African- Americans, Caucasians, those aged 45 to 64, those with annual incomes of less than $24,000 and more than $90,000, and in every region in the country. As another statistic, seniors (those aged 65 and older), those with annual incomes of $48,000 or more, and residents of the South, Midwest, and West had increases in cholesterol rates of a percentage point or more. Seniors are the most likely to report high blood pressure (58.8%), high cholesterol (49.1%), diabetes (22.1%), and heart attack (12.7%). Low-income Americans (those making less than $24,000 per year) have some of the highest rates of high cholesterol (30.2%), diabetes (15.9%), heart attack (7.3%), asthma (15.7%), and depression (29.4%). African- Americans are disproportionately affected by high blood pressure (39.0%) and diabetes
(15.6%)."
It is well-known that tackling the rising rates of high blood pressure and high cholesterol in the United States would have a significant impact on cutting healthcare costs and in reducing the prevalence of related issues such as heart attack and stroke.
Cholesterol lowering drugs (statins) exist, however they have been widely known to cause severe side effects. These include: muscle problems, polyneuropathy (nerve damage in the hands and feet, and rhabdomyolysis (a serious degenerative muscle tissue condition), anemia, acidosis, sexual dysfunction, immune depression, pancreas or liver dysfunction, including a potential increase in liver enzymes, cataracts, cognitive problems and memory loss, and blood glucose elevation, etc.
These side effects cause catastrophic health issues, and it is, therefore, very important to avoid these dangerous drugs, and use a nutraceutical approach to lowering LDL cholesterol.
Obesity is a leading preventable cause of death worldwide, which has an increasing prevalence in adults and children. It is currently viewed as one of the most serious public health issues of the 21st century. Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy and/or increased health problems. Obesity increases the likelihood of various diseases, particularly heart disease, type 2 diabetes, obstructive sleep apnea, certain types of cancer and osteoarthritis. Obesity is most commonly caused by a combination of excessive food energy intake, lack of physical activity, and genetic susceptibility. Anti-obesity drugs exist; however, those may have serious/negative side effects. In severe cases surgery is performed or an intra-gastric balloon is placed to reduce stomach volume and/or bowel length, leading to earlier satiation and reduced ability to absorb nutrients from food. Medication and surgery are very expensive methods to treat obesity, and are usually utilized at an advanced stage of this condition.
The Society of Actuaries recently reviewed almost 500 research papers that studied the effect that obesity has on health and life expectancy; they published the results of their review in the paper, Obesity and Its Relation to Mortality and Morbidity Costs. The report shows that two- thirds of Americans are considered overweight, with a body-mass index (BMI) of 25 or higher; one-third is considered obese with a BMI of 30 or higher.
A number of studies estimated the average or median health care costs per person associated with these different BMI groups. Compared to the healthy BMI group, the overweight BMI group had higher annual medical costs that ranged from a few hundred dollars per year to more than $2,000 per year. There were similar increases when comparing the obese BMI group to the overweight BMI group.
Another eye-catching number from this report is that the total annual economic cost of having citizens who are overweight and obese in the United States and Canada was
approximately $300 billion in 2009. That figure is based on medical costs, excess mortality, and disability costs.
Diet therapy is the most basic, the least invasive and therefore the most optimal method for treating obesity and excessive weight. However, some of the current diets are very rigorous and time consuming. It is essential to take that into account when suggesting a diet. At the same
time, the more natural the diet ingredients, the better they are digested and processed by the body. There thus remains a need for a suitable nutritional composition that can be consumed to lower LDL cholesterol and triglycerides from the blood stream.
SUMMARY OF THE INVENTION
The present invention provides a composition for oral ingestion for lowering LDL cholesterol and triglycerides in a subject. The composition comprises, or consists essentially of, a mixture of raw buckwheat and cultured dairy drink. The raw buckwheat is preferably buckwheat flour and the cultured dairy drink comprises a lactic acid microorganism and a yeast. In certain embodiments the cultured dairy drink is kefir. In certain embodiments the mixture of raw buckwheat flour and cultured dairy drink has been mixed and allowed to sit for about 8 hours at room temperature before consumption.
The present invention also provides a kit comprising raw buckwheat and cultured dairy drink and instructions for mixing the raw buckwheat and cultured dairy drink.
A method of manufacturing a nutraceutical combining raw buckwheat and cultured dairy drink is another embodiment of the invention. In certain embodiments, the method involves processing the raw buckwheat into a flour, powder or fine grain by extrusion and also involves sterilizing the buckwheat with heat, preparing the cultured dairy drink; and combining the buckwheat and cultured dairy drink.
Another embodiment of the invention provides a method of lowering serum LDL cholesterol and/or triglycerides in a subject. The method involves orally administering a mixture of raw buckwheat and cultured dairy drink for a period of 2-8 weeks. In certain embodiments, the mixture comprises 1 oz. of raw buckwheat and 4 oz. cultured dairy drink. DETAILED DESCRIPTION OF THE INVENTION
It is an object of the present invention to provide a very simple diet composition that is beneficial to health by comprising natural nutrition ingredients, which together are capable of effectively reducing LDL cholesterol level, lowering blood pressure, as well as assisting in body fat reduction and improving the overall health and well-being. Accordingly the invention provides compositions for oral ingestion that is useful for lowering LDL cholesterol and
triglycerides in the serum of a subject. In addition, compositions may improve digestion and may improve the digestion of lactose. Compositions of the invention comprise a mixture of raw buckwheat and a cultured dairy drink. The composition may also consist essentially of a mixture of raw buckwheat and cultured dairy drink, meaning that the compositions may include additives for taste and preservation, coloring, stabiliers, etc., but does not contain other "active" ingredients for reducing LDL cholesterol and triglycerides in the serum of a subject.
In some embodiments, compositions may further include other "active" ingredients such as probiotics to aid in digestion or red yeast rice extract to further assist in the reduction of overall cholesterol.
As used herein, "buckwheat" includes any member of the Polygonaceae family that is edible. The traditionally edible Polygonaceae is Fagopyrum esculentum, or buckwheat.
Buckwheat includes any portion or fraction of edible buckwheat. The traditional buckwheat crop for human and animal consumption is Fagopyrum esculentum. A related species, Fagopyrum tataricum (Tartary buckwheat), is also cultivated as a grain in the Himalayas. Despite the name, buckwheat is not related to wheat, as it is not a grass. Instead, buckwheat is related to sorrel, knotweed, and rhubarb. Because its seeds are eaten, it is referred to as a pseudo-cereal.
As used herein, the term "cultured dairy drink product," means any cultured dairy drink product including any dairy drink product that has been cultured with at least one bacterium strain and one yeast strain. A cultured dairy drink product may include kefir. Kefir is a cultured dairy drink made with kefir "grains" (a yeast/bacterial fermentation starter) and has its origins in the north Caucasus Mountains. It has been traditionally prepared by inoculating cow, goat, or sheep milk with kefir grains.
Kefir grains are a combination of lactic acid bacteria and yeasts in a matrix of proteins, lipids, and sugars, and this symbiotic matrix, forms "grains" that resemble cauliflower. For this reason, a complex and highly variable community of lactic acid bacteria and yeasts can be found in these grains although some predominant, Lactobacillus species are always present. Kefir grains contain a water-soluble polysaccharide known as kefiran, which imparts a rope-like texture and feeling in the mouth.
The cultured dairy drink product in the composition can be kefir, or it can be another cultured dairy drink product containing a lactobacillus bacterium strain and a yeast strain.
The cultured dairy drink product may preferably contain the lactic-acid microorganisms at a concentration of 10 7 colony-forming units (CFUs) per cubic centimeter (cm 3 ).
The dairy drink product used to make the cultured dairy drink product can include all types of milk, including whole, skim, part skim, or any fat percentage milk (for example, but not limited to 0.1%, 1.0%, 2.0%, 2.5%, 3.2%, 4%), buttermilk, goat and sheep milk. Preferably the milk is non-fat or low fat milk. The milk can be raw milk, pasteurized or homogenized milk. The milk can also be dried and reconstituted milk. The milk can be a mixture of any of the milks. The cultured dairy drink product can be any of the milks described above as long as it comprises at least one type of lactic acid microorganism and at least one type of yeast.
The cultured dairy drink product maybe freeze-dried, or otherwise prepared so it has reduced moisture content, or preserved, so that it does not need not to be refrigerated for storage. One of ordinarily skill in the art would know how to prepare the cultured dairy drink product in dried, partially dried or fully hydrated form to preserve the product for consumption following storage for a prescribed time. The cultured dairy drink product maybe ultra-heat treated or pasteurized for longer-term storage at refrigerated temperatures.
In some embodiments, compositions further contain yogurt in addition to the cultured dairy drink product and raw buckwheat. The yogurt may contain natural or added probiotics or prebiotics.
The composition can contain flavor fillers to enhance the taste and texture of the composition. For example, the composition may contain honey, agave, fruits, fruit juices, sweeteners (natural or synthetic), vegetables, vegetable juices, and natural or artificial flavors. The composition may also or alternatively contain fruit preparations (jams, mix of fruits/berries with sweeteners, preservatives, etc.). The composition can contain other additives useful to improve the taste, texture, stability, appearance, etc. of the composition, such as but not limited to, colorants, stabilizers, preservatives, and emulsifiers, etc.
The raw buckwheat is preferably an unrefined raw buckwheat flour or powder obtained from raw buckwheat groats. The buckwheat flour may be organic and it may be light or dark buckwheat flour. The flour can be obtained by extrusion in the presence of water during a thermo-mechanical treatment. During the extrusion process, heat can be added to kill or deactivate any germs or microbes that may be present, however the heat does not cook the
buckwheat and it remains raw. The raw buckwheat may also be in the form of, but is not limited to, a whole buckwheat grain, a refined grain, a processed or ground grain, or raw flour manufactured to be in the form of a flake or granule. Raw buckwheat may be processed into a flour using standard milling techniques used in obtaining flour from other grains like, wheat, spelt, amaranth, etc. In some instances, during the milling process, different screens ranging from 30 to 120 mesh are used. The majority of dark buckwheat remains on the 60-70 screens.
The buckwheat groats may have the hull resulting in all of the hull being present in the buckwheat flour. In some instances, the buckwheat groats have the hull removed and in this case, there is no null in the flour.
The composition of raw buckwheat and cultured dairy drink product can range in their ratios relative to each other. For example, the weight ratio of raw buckwheat to cultured dairy drink may include, but is not limited to: 20/80 percent by weight ratio, 30/70 percent by weight ratio, 40/60 percent by weight ratio, 50/50 percent by weight ratio, 60/40 percent by weight ratio, 70/30 percent by weight ratio, and 80/20 percent by weight ratio.
The invention also provides a composition of raw buckwheat and cultured dairy drink that has been mixed together and allowed to sit for about 8 hours at room temperature. The mixture can sit mixed together from a period of 1-8 hours, from 2-16 hours, for 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 hours. If raw extruded buckwheat flour is used, the mixture with the cultured dairy drink can be consumed right after mixing. In the extrusion process, the buckwheat is still raw, but the process cleans the buckwheat and removes any bacteria.
If whole raw buckwheat grains are used, then the mixture needs to sit to allow the grains to soften to be more palatable.
The composition can be made to be any desired consistency for consumption. For example, it can be made so it is more like a drink, or it can be like a "smoothie'Vmilk shake consistency, or like a yogurt or porridge consistency. The composition can also be made and then dried or formed into a snack bar or even dried and then crumbed into a cereal/grain consistency.
The present invention also provides a composition in a dosage form suitable for daily consumption or as often as needed per a desired treatment regimen. In one embodiment, the treatment regimen may require a daily serving of the composition comprising two level
tablespoons or 1 oz. (of raw whole buckwheat flour) and 4 oz. of low fat (1%), or non-fat cultured dairy drink.
In other embodiments, the daily serving comprises 5 - 100 g raw buckwheat, 10 - 200 g of raw buckwheat, or 20 - 500 g of raw buckwheat. The daily serving may comprise 2 oz. ( 6 -2 L) - 4 oz. (0.12 L) of cultured dairy drink, 5 oz. (0.15 L) - 10 oz. (0.24 L) of cultured dairy drink, 10 oz. (0.3 L) - 20 oz. (0.6 L) of cultured dairy drink, or 20 oz. (0.6 L) - 40 oz. (1.18 L) of cultured dairy drink.
As discussed previously, the composition preferably comprises optionally fruit, fruit preparations and sweeteners. For example, a daily serving may also comprise 1 oz. of blueberries, 1 oz. of strawberries, and 0.5 oz. of honey.
In certain embodiments, the composition is pasteurized.
The present invention also provides a kit for a nutraceutical comprising raw buckwheat and cultured dairy drink. The kit may comprise a portion of raw buckwheat and a portion of cultured dairy drink product in separate containers/packaging. The raw buckwheat and cultured dairy drink product is as described above.
The kit may further comprise fresh or dried fruit, berries, sweetener: for example, honey, agave syrup, brown sugar, white sugar, sugar substitutes, etc. The kit may also or alternatively contain fruit preparations (jams, mix of fruits/berries with sweeteners, preservatives, etc.).
The kit may also comprise granola, nuts, or other ingredients as part of the nutraceutical. The kit may also include a packet for easily combining all of the ingredients. The container holding the cultured product may have a removable/reusable top, which twists or snaps to allow for mixing the cultured dairy drink product with the raw buckwheat.
The kit may include instructions for mixing, preparing and consuming the nutraceutical. For example, if the cultured dairy drink product was provided in the kit as a freeze-dried product, the kit may contain instructions on the rehydration of the cultured dairy drink product. Further, the kit may contain instructions on how long to allow the combination of the raw buckwheat and the cultured dairy drink product to sit before consumptions and the kit may also contain instructions regarding how and when to consume the product.
The present invention also provides a method of manufacturing a nutraceutical combining raw buckwheat and cultured dairy drink. In a particularly preferred method, the raw
buckwheat is processed to form a powder, flour or fine grain. The raw buckwheat may be processed using a thermo -mechanical extrusion process involving heat to sterilize the buckwheat (but not cook it as the buckwheat is still raw) and to grind the buckwheat seeds into a powder, flour or fine grain. The cultured dairy drink product is preferably kefir. The method of manufacturing can comprise a pasteurization step for the cultured dairy drink product.
The present invention also provides a method of lowering serum LDL cholesterol and/or serum triglycerides comprising ingesting a composition of the present invention for a time period necessary to lower serum LDL cholesterol and/or serum triglycerides. In certain embodiments, the method involves ingesting the composition once a day in the morning on an empty stomach (i.e. before eating breakfast) for a period of about 2 - 8 weeks. Preferably, about two hours are allowed to pass after ingestion of the composition before ingestion of other food. After 2-8 weeks have passed, the subject can have his serum tested and if the levels of LDL cholesterol or serum triglycerides have not yet been reduced to the desired level, the patient can continue on with another cycle of 2-8 weeks or with as many cycles as needed. Maintenance regimens may be taken to maintain the desired healthy levels of LDL cholesterol or serum triglycerides.
In some embodiments, the composition was ingested for three weeks and a lowering of LDL cholesterol was observed. In some instances, a two week treatment occurred over the span of three weeks: one week ingesting a composition of the invention, one week off, and then one week ingesting and in this case a lowering of LDL cholesterol was observed.
The method may further involve administration of prescribed medicines for lowering
LDL cholesterol and/or triglycerides, such as statins.
The composition consumed is as described herein but preferably contains at least 1 ounce of raw buckwheat and 4 ounces of cultured dairy drink.
The composition produces excellent results in lowering LDL cholesterol, as well as reducing body fat, and providing the human body with the following vitamins, minerals and enzymes: manganese, tryptophan, magnesium, dietary fiber, flavonoids (i.e. rutin and quercitin), antioxidants, calcium, phosphorus, Vitamin B12, Bl, and Vitamin K, biotin, folic acid, pantothenic acid, etc.
Throughout the research, it was found that this diet composition had a significant effect in reducing LDL cholesterol levels in a very brief period of time (2-8 weeks). The tables below provide the ranges of LDL cholesterol and what is considered healthy/optimal. Cholesterol Levels (US) - Milligram/deciliter
CLINICAL TESTS:
Tested 2-8 weeks after beginning consumption of 1 oz. of raw buckwheat/4 oz. of cultured dairy drink.
Some of the health benefits of this nutraceutical observed include: reduction in LDL cholesterol levels; reduction in triglycerides levels; reduction in sugar/fat cravings leading to weight loss; prevention of the following conditions - metabolic syndrome, morbid obesity, diabetes, heart attack, kidney failure, pancreatitis, artery hardening and atherosclerosis (which could lead to heart attack, stroke and heart disease); lowering blood pressure; promoting total cardiovascular health; improved blood sugar control and a lowered risk of diabetes; cleansing of the intestines, and contribution to an overall health of the immune system, and reduction of the risk of several kinds of cancer (i.e. colon, breast, stomach, etc.); and elimination or reduction of unhealthy food cravings by making the body more nourished and balanced thereby reducing excess body fat. EXAMPLES
EXAMPLE 1 : Preparation of buckwheat/cultured dairy drink composition
One regimen provides a diet composition comprising two level tablespoons or loz of raw buckwheat and 4 oz. of low-fat (1 %), or non-fat cultured dairy drink.
Preparation of Raw Food Mixture Comprising Buckwheat and Cultured Dairy Drink 1. At night time (prior to going to bed), mix 1 oz. (or two level table spoons) of raw buckwheat with 4 oz. (or half a cup) of cultured dairy drink in a 6-8 oz. cup, and let stand overnight (either uncovered or slightly covered with a paper towel or a lid, which does not seal completely) at room temperature.
2. In the morning, stir the mixture one more time and consume immediately as your first meal of the day. It should be consumed on an empty stomach.
3. When finished with the entire mixture, one may consume the morning beverage of choice (coffee, tea, water, juice).
4. Wait two hours before eating anything else and continue with the rest of your daily regiment as before. No other dietary conditions/restrictions are necessary.
5. Repeat step 1 in the evening.
6. Continue for at least 3 weeks prior to testing LDL again.
7. For best results, repeat this 3-week cycle once every few months (i.e. once a quarter). An alternative therapy can include daily dosages for as long as needed and tolerated.
EXAMPLE 2: Patient results (Patient "N")
Patent N was born in 1952, has had high cholesterol for years, and has tried modifying his diet in every way possible: i.e. eating oatmeal, omega 3s, eating less red meat and fried foods, however his LDL cholesterol stayed constant despite these drastic measures and diets.
Patient N consumed the product described in Example 1 for about a period of a month (with a one- week break in the middle due to travel and his lack of access to the ingredients on his location), after which his LDL cholesterol went down significantly. Most amazingly, he did not change any other elements of his diet during that time, continuing to consume red meat, fried foods, and other foods high in cholesterol. Patient N did not consume any over the counter medicines or prescription medicines for reducing cholesterol.
EXAMPLE 3: Additional test subjects
The additional test subjects reported in the clinical results reported above, consumed flowed the regimen described in example 1. Patient N (example 2) modified the recipe by adding nuts and honey to the composition where the other subjects did not add any additional flavoring agents.
Claims
1. A composition for oral ingestion for lowering LDL cholesterol and triglycerides in a subject, the composition comprising a mixture of raw buckwheat and a cultured dairy drink.
2. The composition of claim 1 wherein the raw buckwheat is buckwheat flour.
3. The composition of claim 1 wherein the cultured dairy drink comprises cultures of a lactic acid microorganism strain and a yeast strain.
4. The composition of claim 3 wherein the cultured dairy drink is kefir.
5. The composition of claim 1 wherein the mixture of raw buckwheat and cultured dairy drink is in a dry form selected from the group consisting of a snack bar, cereal or cereal flake.
6. The composition of claim 1 wherein the mixture of raw buckwheat flour and cultured dairy drink has been mixed and allowed to sit for at least 8 hours at room temperature before consumption.
7. A kit for a nutraceutical comprising raw buckwheat and a cultured dairy drink and
instructions for mixing the raw buckwheat and cultured dairy drink.
8. A method of manufacturing a nutraceutical combining raw buckwheat and cultured dairy drink, the method comprising:
processing the raw buckwheat into a flour, powder or fine grain;
sterilizing the buckwheat;
preparing the cultured dairy drink; and
combining the buckwheat and cultured dairy drink.
9. A method of lowering serum LDL cholesterol and/or triglycerides in a subject comprising orally administering a mixture of raw buckwheat and cultured dairy drink for a period of 2-8 weeks, and wherein the mixture comprises 1 oz. of raw buckwheat and 4 oz. cultured dairy drink.
10. A composition for oral ingestion for lowering LDL cholesterol and triglycerides in a subject, the composition consisting essentially of raw buckwheat and cultured dairy drink.
11. The composition of claim 1 further comprising yogurt.
12. The composition of claim 10 further comprising yogurt.
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