Beverage composition and method of forming the same

Abstract

To provide a beverage composition for improving cognitive function, managing and / or treating type II diabetes, reducing postprandial glycemia, and promoting weight loss.SOLUTION: A beverage composition comprising at least 600 mg polyphenols and at least 1 g of fiber, the beverage composition being less than 100 Kcal, is provided.SELECTED DRAWING: None

Description

[Technical Field]

[0001] This application, the contents and elements of which are incorporated herein by reference for all purposes, Priority is claimed to GB2003327.0, filed on March 6, 2020.

[0002] The present disclosure relates to beverage compositions and methods of making beverage compositions that provide a desirable feeling of satiety. In particular, the present disclosure relates to beverage compositions comprising polyphenols and fiber. improved cognitive function, management and / or treatment of type 2 diabetes, reduction of postprandial blood glucose, and and the use of the beverage composition in promoting weight loss, respectively. [Background technology]

[0003] Consumers want to get energy from the foods and beverages they consume. As people become more diet and nutrition conscious, they are increasingly turning to natural and healthy foods and beverages. Consumers seek a temporary boost in satiety and mental and physical performance. Meals and snacks with a high glycemic index provide a source of energy to meet the need for It is not always suitable as it generally does not provide long-lasting effects. Although it is often used to replace carbohydrate-based energy sources, many consumers currently consume They believe caffeine should be limited and therefore prefer to use it sparingly.

[0004] A variety of solid biscuit-based snack foods are already available on the market. Research has shown that by providing a specific, slow-release source of calories, it can provide sustained energy. It is known that steroids can increase satiety and delay the onset of hunger. Such products are expected to provide numerous health benefits and their availability is highly anticipated. It is generally desired.

[0005] One way to achieve increased satiety is to provide a source of fiber that is less easily digested by the body. This is known to delay gastric emptying and increase the feeling of satisfaction after ingestion. It can be seen. DISCLOSURE OF THE INVENTION

[0006] Description of the Invention Therefore, the present invention provides food replacement, particularly beverage, compositions having the beneficial health effects described herein. and methods for making same, and / or to alleviate some of the problems associated with the prior art. addressing some of the issues, or at least providing commercially viable alternatives to them. It is desirable to provide

[0007] In a first embodiment, at least 600 mg of polyphenols and at least 1 g of fiber A beverage composition is provided comprising:

[0008] The invention will now be further described. In the following text, different aspects of the invention will be described in more detail. Each aspect so defined is optional unless expressly indicated to the contrary. It may be combined with one or more other aspects of the present invention. Any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous. It may be combined with a number of features.

[0009] The present invention relates to beverage compositions. A "beverage composition" is a beverage that is prepared immediately or in a beverage medium, typically a beverage containing a beverage. a composition suitable for human consumption as a beverage either after reconstitution or dilution with water means.

[0010] Thus, in one embodiment, the beverage composition is ready to drink. ) and the volume is 100 to 1000 ml, preferably 100 to 750 ml, preferably 150 to 1000 ml. It has a volume of 500 ml, preferably 200 to 300 ml. In a ready-to-drink beverage having a volume of 0 ml, at least 600 mg of polyphenols and and at least 1 g of fiber are provided.

[0011] In an alternative embodiment, the beverage composition is a concentrate for forming a beverage upon reconstitution with water. The final volume of the beverage after formation is the same as for the ready-to-drink compositions discussed above. The concentrate format is a concentrated liquid or gel formulation for dilution with a beverage medium. For example, the concentrate may be added to a vessel, and then water may be added, or the vessel containing water may be The beverage may be formed after adding the concentrate to the beverage (e.g., by adding to a bottle and shaking). The concentrate may also be a powder, such as a freeze-dried or spray-dried powder, and may be reconstituted in the same manner. Given the challenges of suspending significant amounts of fiber, it is recommended that the composition be ready-to-drink. Most preferably, the formulation is a liquid concentrate.

[0012] Polyphenols The beverage composition contains at least 600 mg of polyphenols. Polyphenols are micronutrients that may enter the diet through certain plant foods. They are characterized by the presence of a number of phenolic structural units. The characteristics and properties underlie the unique physical, chemical, and biological properties of particular members of a class. Polyphenols are known to have antioxidant properties and potential health benefits. Polyphenols have been shown to help with: digestive problems, weight management difficulties, diabetes, neurodegenerative diseases, and and can improve the health of individuals with, or reduce the risk of, cardiovascular disease. The level of polyphenols in the composition was determined using a colorimetric assay. Such assays are well known in the art. be.

[0013] Many foods in a healthy diet come from fruits, vegetables, grains, tea and coffee. Contains high levels of naturally occurring phenols found in grapes, apples, pears, and cherries. Fruits such as mushrooms and berries contain up to 200-300 mg of potassium per 100 grams of fresh weight. Contains phenols. Typically, one glass of red wine or one cup of tea or coffee Each tea contains approximately 100 mg of polyphenols.

[0014] As will be appreciated, a dose of 600 mg in a maximum of 1 liter, preferably less, of a drink is Polyphenols provide a significant improvement over what can be achieved by consuming natural polyphenol sources. Blackcurrants typically contain about 25g of polyphenols per 100g of fresh fruit. 0mg, so you would need to eat at least 250g of fruit to achieve the minimum required dose. Preferably, the beverage composition contains 700 to 2000 mg of polyphenols, Preferably, it contains 800 to 1200 mg of polyphenols.

[0015] In one embodiment, the concentration of total polyphenols in the beverage composition is between 500 and 10,000 pM. pm, 600~8,000ppm, 700~7,500ppm, 800~7,000ppm m, 1,000~6,500ppm, 1,200~6,000ppm, 1,500~5, 500ppm, 1,800~5,200ppm, 2,000~5,000ppm, 2,2 50~4,750ppm, 2,500~4,500ppm, 600~6,000ppm, 800~6,000ppm, 1,200~4,000ppm, 2,000~3000ppm m or 800 to 1,200 ppm.

[0016] The polyphenols can be synthetically produced. However, preferably, the beverage composition contains concentrated fruit extracts as a source of polyphenols. The use of natural sources This will result in a more nutritionally diverse selection of phenols, which will be perceived as healthier by the end consumer. This allows for clean labeling of the product (i.e., no artificial chemical additives). The fruit extract typically consists essentially of polyphenols.

[0017] Preferably, the fruit extract is derived from one or more anthocyanin-rich fruits. Anthocyanin-rich fruits are red, purple, blue, or black in color due to their anthocyanin content. As used herein, anthocyanin-rich The fruit contains at least 200 mg of polyphenols per 100 g. New anthocyanin-rich fruits include blackcurrants, blackberries, blueberries, and pomegranates. or a combination of two or more thereof. The fruit rich in anthocyanins is blackcurrant. Most preferably, the composition comprises or consists essentially of black currant.

[0018] Preferably, the polyphenols consist essentially of blackcurrant polyphenols. It is a rich source of polyphenols and is an easy way to obtain a rich source of polyphenols. Polyphenols can be found in blackcurrants (and other anthocyanins) and can be processed and concentrated. Since polyphenols are often found in the skin of fruits (fruits rich in polyphenols), polyphenols should preferably be extracted from the fruit. Polyphenols can be obtained as a by-product of the juice process. , useful additives can be obtained from materials that would otherwise be considered waste.

[0019] Preferably, the polyphenols in the fruit comprise a large proportion of anthocyanins. The anthocyanin profile is composed of four anthocyanins: delphinidin and Contains (or consists essentially of) the 3-O-glucoside and 3-O-rutinoside of cyanidin In one embodiment, the anthocyanin profile is at least 50%, at least at least 60%, at least 70%, at least 80%, at least 85%, at least It may contain 90% or at least 95% of the four anthocyanins.

[0020] In one embodiment, the polyphenol-containing fruit extract is a whole fruit, fruit part, or It can be obtained from the fruit pomace and / or the fruit marc. The fruit parts are the flesh, pulp, peel, etc. , flavedo and / or albedo.

[0021] fiber The beverage composition contains at least 1 g of fiber. The fiber present is also known as dietary fiber. Dietary fiber is the portion of plant-based foods that cannot be completely broken down by human digestive enzymes. Fiber has two main components: 1) Water-soluble fiber, which dissolves in water and is easily absorbed by the large intestine. fermented into gas and bioactive by-products such as short-chain fatty acids produced in the large intestine by intestinal bacteria. It is viscous and is sometimes called prebiotic fiber, which helps to slow gastric emptying. 2) It is water-soluble and can delay the absorption of food, thereby providing a long-term feeling of satisfaction in humans. Undigested insoluble fiber is inactive to the digestive enzymes of the upper gastrointestinal tract and contributes to bulking. Dietary fiber includes cellulose, resistant starch, resistant dextrin, inulin, and lignin. non-starch polysaccharides such as chitin, pectin, beta-glucan, oligosaccharides and other Preferably, the beverage composition contains 1.25 to 3.5 g of fiber, preferably Contains 1.5-2g of fiber. The level of fiber in the composition is determined in accordance with AOAC 991.43. Such testing techniques are well known in the art.

[0022] As can be seen, 1 gram of fiber is a significant amount to be present in a beverage. Pulp-containing orange juice sources typically contain approximately 0.2 g of fiber per 100 ml. Therefore, especially for smaller beverages than those contemplated herein, the fiber dosage Techniques for assessing fiber levels in foods are well known in the art. It is knowledge.

[0023] In one embodiment, the concentration of fiber in the beverage composition is 0.5 to 20 g / L, 1.0 to 19 g / L, / L, 1.5~18g / L, 2.0~17g / L, 2.5~16g / L, 3.0~15g / L, 3.5~14g / L, 4.0~13g / L, 4.5~12g / L, 5.0~11g / L, 5.0~10g / L, 1.0~10g / L, 1.3~10g / L, 2.0~6.7 g / L, or 3.3 to 5.0 g / L.

[0024] Preferably, substantially all of the fibers are natural fibers. Preferably, the fibers are pulps of cells. The pulp is preferably provided as a pulp (where pulp is defined as the mashed fruit mass). In some embodiments, the composition comprises or consists essentially of citrus fiber as a source of fiber. In the case of citrus fiber, the majority of the fiber is provided by the cell walls of the pulp structure. Fruit sources include lemon, lime, orange, and grapefruit products, as well as their A blend of two or more of the above is also included.

[0025] The citrus fiber does not have an unpleasant effect on flavor and does not create a sticky or creamy mouthfeel. This is particularly preferred because it can be provided in a desired amount without causing any hits. are familiar with the sensation of beverages containing citrus pulp. Several other fiber sources are found in beverages Please note that this may be accompanied by astringency and / or gelling.

[0026] In one embodiment, the fiber is obtained from whole fruit, fruit parts and / or fruit pomace. The parts of the fruit may be the flesh, pulp, skin, peel, flavedo and / or aloe. Preferably, the fiber is obtainable from the pulp of the fruit.

[0027] In one embodiment, the beverage composition may contain commercially available fiber. l Unipectin-100, Unipectin-3 manufactured by Incorporated 00 and Unipectin-900, and Doehler's Citrus Pe ctin can be used in a beverage composition according to one embodiment of the present invention.

[0028] calorie Preferably, the beverage composition is less than 100 Kcal (including less than 100 Kcal). As mentioned above, orange juice typically contains approximately 0.2g of fiber per 100ml. But this also means that there are roughly 8g of sugars per 100ml and about 4g of fat per 100ml. 5 kcal. Therefore, it contains less than 100 kcal and at least 1 g of fiber. Providing this is quite different from any typical fruit juice drink.

[0029] Alternatively, the beverage composition may be 100 Kcal or less. , the beverage composition may be less than 95Kcal, less than 90Kcal, less than 85Kcal, less than 80Kcal Less than l, Less than 75Kcal, Less than 70Kcal, Less than 65Kcal, Less than 60Kcal, Includes less than 55Kcal, less than 50Kcal, less than 45Kcal or less than 40Kcal In a preferred embodiment, the beverage composition has less than 100 Kcal / 100 ml, 95 Kcal Less than l / 100ml, Less than 90Kcal / 100ml, Less than 85Kcal / 100ml, Less than 80Kcal / 100ml, Less than 75Kcal / 100ml, 70Kcal / 100 Less than ml, 65Kcal / 100ml, 60Kcal / 100ml, 55Kcal Less than l / 100ml, less than 50Kcal / 100ml, less than 45Kcal / 100ml or less than 40 Kcal / 100 ml. In other embodiments, the beverage composition contains 10 to 1 00Kcal / 100ml, 15~95Kcal / 100ml, 20~90Kcal / 1 00ml, 25~85Kcal / 100ml, 30~80Kcal / 100ml, 35~ 75Kcal / 100ml, 40~70Kcal / 100ml, 5~50Kcal / 10 0ml, 6~45Kcal / 100ml, 7~40Kcal / 100ml, 8~35Kc al / 100ml, 9~30Kcal / 100ml or 10~25Kcal / 100ml l.

[0030] Preferably, the beverage obtained from the beverage composition is a ready-to-drink composition, particularly if the beverage composition is a ready-to-drink composition. In some cases, the sugar content is less than 5g / 100ml. However, sugars are generally not present in the accompanying meal or snack. Therefore, the beverage composition has a low sugar content. It is desirable.

[0031] Preferably, the beverage composition contains fiber (provided as a citrus fiber extract), polyphenols, and / or citrus fruits. (provided as concentrated fruit extract) along with any added sweeteners (including sugars) and flavorings (and water, if provided in concentrate and ready-to-drink form) Other conventional ingredients such as stabilizers and pH adjusters may be present in small amounts, if desired. Good too.

[0032] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal and provided in a dose having a volume of about 200 ml. It is a ready-to-drink beverage composition, i.e., the recommended serving size is 200 ml. At smaller dose sizes, the fiber level can also result in an overly pulpy beverage. There is a possibility that this may happen.

[0033] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal and provided in a dose having a volume of about 250 ml. It is a ready-to-drink beverage composition, i.e., the recommended serving size is 250 ml. be.

[0034] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal and provided as a dose having a volume of about 300 ml. It is a ready-to-drink beverage composition, i.e., the recommended serving size is 300 ml. be.

[0035] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal, and provided in a dose having a volume of about 330 ml. It is a ready-to-drink beverage composition, i.e., the recommended serving size is 330 ml. be.

[0036] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1 g of fiber, e.g., 800-1200 mg of polyphenols and 1-2 g of fiber, Preferably less than 45 Kcal and provided in a dose having a volume of about 500 ml It is a ready-to-drink beverage composition; i.e., the recommended serving size is 500 ml. do.

[0037] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal and provided in a dose having a volume of about 750 ml. It is a ready-to-drink beverage composition, i.e., the recommended serving size is 750 ml. be.

[0038] The most preferred beverage compositions contain at least 600 mg of polyphenols and at least 1g of fiber, e.g., 800-1200mg of polyphenols and 1-2g of fiber , preferably less than 45 Kcal and provided as a dose having a volume of about 1000 ml. A ready-to-drink beverage composition containing 1000ml of water. At larger dose sizes, it becomes difficult to keep the fibers suspended and the dose itself This in itself may be larger than many consumers wish to consume.

[0039] The most preferred beverage composition contains 600-6,000 ppm polyphenols and 1.0 ~10g / L of fiber, preferably 1,200-4,000ppm of polyphenols or It contains 800 to 1,200 ppm of polyphenols and 1.3 to 10 g / L of fiber. Preferably, it is 1 to 50 Kcal / 100 ml, and more preferably, it is 1 to 30 Kcal / 100 ml. The amount of one serving is 50 ml to 1,000 ml, preferably is 100ml to 800ml, more preferably 200ml to 500ml or 600ml to A serving may contain at least 600 mg of polyphenols, preferably Preferably, 700 to 2000 mg of polyphenols, more preferably 800 to 1200 mg of polyphenols. May contain phenol. More than one dose may be contained in one container. For example, a single serving of the beverage composition may be 200 ml and one container may contain 1,000 ml of beverage. If the composition is contained in a container, the container may provide 5 doses. Alternatively, a single dose A single serving may be comprised of more than one container. For example, a single serving may be 200 ml, one serving may consist of four 50 ml bottles or two 100 ml bottles. Generally, consumers expect to receive the benefits of a beverage composition from a full bottle. The amount of serving (or portion size) needed to get a benefit is called pack size. If the serving size is different from the pack size, the serving size may be different, e.g. It may appear on the label, promotional material, or accompanying information leaflet.

[0040] The inventors have achieved the above object by providing a synergistic mixture of polyphenols and fiber. We have now discovered that many of the beneficial health effects described in theory can be achieved. You don't want to be tied down, but fiber increases satiety, while polyphenols slow down sugar uptake. In combination, these are thought to provide energy to consumers. It is particularly surprising that such benefits can be achieved in the form of a beverage composition. This is in line with the level of solids (i.e., non-water components) achievable in such beverages. This is because the formula is very strictly limited, i.e. thickening the beverage to make it clearer. There is a limit to the amount of fiber and other additives that can be introduced into a beverage before it becomes unpalatable. Drinks containing high amounts of fiber can become extremely thick or gel-like, almost like a solid. However, despite these limitations, Without further ado, the inventors were able to produce a desirable beverage with observable benefits.

[0041] The inventors have explored the inclusion of fiber alone to provide sustained release energy. However, fiber must be formulated in the required dosage due to the consistency of the formulation and the associated costs. The present inventors have developed a polyphenone to slow down the rate of glucose entering the body. However, polyphenols are extremely expensive and have no effect on blood sugar. The inventors have found that in providing two blends, the individual We have now been able to provide effective compositions that overcome these drawbacks associated with these ingredients.

[0042] The inventors have provided a violet-colored, low-calorie beverage. The pulp also provides a satisfactory mouthfeel. The drink is not too sweet, slightly sour, and has a pleasant fruity flavor. In particular, the beverage is derived from entirely natural fruit ingredients.

[0043] Inclusion of high doses of polyphenols is expensive and results in bitter tasting formulations. Surprisingly, the inventors have found that, in particular, in cases based on anthocyanin-rich fruits, In this case, it was found that the effective dose of polyphenols does not need to be excessively large. A smaller dose of 800 mg is as effective as a larger dose of about 1600 mg. It was found that.

[0044] We investigated different doses of blackcurrant and sweet orange polyphenols. The significant effect of 800 mg of black currant on the plasma glucose absorption rate, which is closely related to the rate of glucose absorption in the intestine. The difference in early postprandial glucose concentration was strongly supported by GIP secretion. had a minor impact on

[0045] Soluble and insoluble dietary fiber from Spanish lemon and orange pomace This allows us to compare their characteristics and infer their biological functions. The aim was to identify the effective fraction of fibre to be used and thereby reduce the required The aim was to reduce the amount of fiber. Lemon fiber was higher than that of the other fiber sources considered. It has been found that the viscosity is maintained at a suitable concentration.

[0046] Next, blackcurrant and pulp were tested. The increase in glucose, insulin, c-peptide and GIP at 0 min was not significant. It was found that the addition of pulp produced a statistically significant inhibitory effect, but this effect was not limited to pulp alone. No significant difference was found, suggesting that BCPP may inhibit carbohydrate digestion and intestinal glucose absorption. This further supports previous findings suggesting that reaction time and cognitive performance / working memory , improved by BC and pulp but not by pulp, and BC PP This suggests that the subjective score of appetite and the amount of food consumed after drinking the beverage may be improved. There was no difference in the amount of energy consumed at the next meal, making it unlikely that BC+pulp would alter the amount of energy ingested at the next meal. Lower doses of BC PP, equivalent to approximately 100g of fresh fruit, were shown to be beneficial for healthy growth. It has been shown to slow the rate of early postprandial blood glucose and slow intestinal absorption in humans.

[0047] According to another aspect, the beverage compositions described herein are intended to provide a method for the treatment of cognitive impairment in a subject in need thereof. The beverage compositions described herein are also provided for use in improving cognitive function. The present invention provides a method for improving cognitive function by administering the compound to an elephant. promote temporary improvements in cognitive function, maintain normal cognitive function, and improve cognitive function in either the short or long term Reducing the risk of cognitive impairment in people with aging, e.g., minimizing the likelihood of age-related decline in mental function, e.g., For example, temporary improvement in healthy subjects, maintenance of normal cognition in healthy subjects, or improvement of existing cognition. Acute or chronic improvement in subjects with a disorder or risk of developing abnormal cognitive function This may include reducing noise.

[0048] In one embodiment, a method for improving cognitive function in a subject, comprising administering to a subject a therapeutic agent according to the present invention. Uses of the beverage compositions are provided. As used herein, "improving cognitive function in a subject" refers to improving cognitive function in a subject. Non-therapeutic methods for improving cognitive function include promoting temporary improvements in cognitive function, maintaining normal cognitive function, and and reducing the risk of cognitive impairment in either the short or long term, e.g., age-related mental disorders Minimizing the possibility of functional decline, e.g., temporary improvement in healthy subjects, Maintenance of normal cognition in healthy subjects, maintenance or increase of alertness / wakefulness / mental performance in healthy subjects and a reduction in reaction time and feelings of sleepiness in healthy subjects. The present invention relates to a beverage composition for use in a method of treatment for improving cognitive function in a subject in need thereof. As used herein, "a method for treating cognitive impairment in a subject in need thereof" is provided. The "treatment method for improving cognitive function" refers to the treatment of acute or chronic improvement in subjects with pre-existing cognitive impairment. Benefits, reduced risk of developing abnormal cognitive function, Alzheimer's, dementia, mild cognitive impairment and This includes reducing the risk of developing mild cognitive decline, as well as age-related cognitive decline.

[0049] According to another aspect, the beverage compositions described herein are useful for managing symptoms of type 2 diabetes. and for use in a method for managing and / or treating type II diabetes, comprising: Additionally, the beverage composition is provided for use in a method for reducing the risk of developing type 2 diabetes. Furthermore, by administering the beverage composition described herein to a subject, it is possible to improve type II diabetes. The present invention provides a method for managing and / or treating the long-term effects of poor postprandial glycemic control. A significant reduction in blood cholesterol is associated with a reduced risk of developing diabetes.

[0050] According to another aspect, the beverage compositions described herein may be used to reduce the risk of cardiovascular disease (CVD). Also provided are beverage compositions described herein for use in methods of reducing administration provides a method for reducing the risk of cardiovascular disease (CVD).

[0051] In one embodiment, in a non-therapeutic method of maintaining a healthy heart and circulation in a subject, Use of the beverage composition according to the present invention is provided. In another embodiment, the beverage composition is used to treat cardiovascular disease in a subject. Beverage compositions for treating, preventing or curing diseases are provided.

[0052] According to another aspect, the beverage compositions described herein are suitable for use in methods for reducing postprandial blood glucose. In addition, by administering the beverage composition described herein to a subject, Methods for reducing postprandial blood glucose are provided.

[0053] In particular, without wishing to be bound by theory, the inventors believe that the combination of fiber and polyphenols The combination reduces postprandial blood glucose by both slowing glucose transit and reducing uptake. , improving mental energy, and has the undesirable effect of reducing blood sugar levels below optimal This is consistent with many beneficial health outcomes, including a reduced likelihood of excessive insulin release resulting from They found that this resulted in a sustained release of glucose into the blood.

[0054] In one embodiment, the available energy (calorie source) in the blood required for the daily living of a subject is and consumer-perceived energy (feelings of mental and physical vitality and physical and and the use of a drinking alcoholic beverage according to the present invention in a non-therapeutic method of managing cognitive impairment (defined as cognitive function and mental executive function). Use of the composition is provided.

[0055] According to another aspect, the beverage compositions described herein are characterized by a blood glucose-induced insulin response. The present invention is also provided for use in a method for preventing or reducing the risk of hypoglycemia caused by a By administering the beverage composition described in the present specification to a subject, blood glucose-induced insulin response is suppressed. Methods for preventing or reducing the risk of hypoglycemic events resulting from the administration of steroids are provided.

[0056] According to another aspect, the beverage compositions described herein are intended to improve the body's ability to function in a subject in need thereof. For use in methods to promote weight loss and / or improve body mass index (BMI) In addition, the beverage compositions described herein may be administered to a subject to improve weight loss. Methods for promoting reduction are provided.

[0057] In one embodiment, the method promotes weight loss and / or improves body mass index in a subject. There is also provided the use of a beverage composition according to the present invention in a non-therapeutic method for improving the When used in a subject, "promotes weight loss and / or improves body mass index in a subject" Non-therapeutic methods for smoothing blood sugar curves, providing a continuous supply of energy in the blood, and good vitality, avoidance of peaks and troughs in energy and mood, maintenance of normal weight, and Including weight loss for minor aesthetic concerns that did not require GP intervention. promote weight loss and / or body mass index in a subject in need thereof Beverage compositions are provided for use in methods of treatment to improve "promoting weight loss and / or body mass index reduction in a subject in need thereof" The "treatment method to improve obesity" is a medical treatment for the treatment of obesity, the prevention of obesity-related diseases, and the maintenance of health. requested / recommended by a teacher or if the user is diagnosed by a physician as overweight or clinically obese This includes administering to a subject once diagnosed.

[0058] Regarding the above-mentioned uses, the use is intended for subjects who are specifically consuming a standard diet. In these examples, the composition may be administered after ingestion of a meal or snack, particularly a carbohydrate-rich meal. the rise in blood glucose levels of a subject, e.g., a normal response (or a subject not administered the beverage composition) It is helpful to limit the response to less than 50%, more preferably less than 30% of the normal response.

[0059] According to another aspect, there is provided a method of forming the beverage compositions described herein, comprising: The method includes mixing a fruit extract rich in ethanol with a natural fiber component. The sources of the ingredients are discussed herein.

[0060] According to another embodiment, at least 600 mg of polyphenols and at least 1 g of fiber. Beverage compositions containing fiber are provided that are consumed in conjunction with or prior to a carbohydrate supplement. The beverage compositions described herein may also be administered to a subject in conjunction with or prior to carbohydrate supplementation. The present invention provides a method for administering a beverage composition to an elephant, the beverage composition being ingested or administered prior to carbohydrate supplementation. In one embodiment, the carbohydrates are from bread, cereals, It may also be a carbohydrate-containing food such as rice, pasta, potatoes and sweets. In the present invention, the beverage composition may be administered to a subject before the subject ingests carbohydrates, or The beverage composition may be administered to a subject together with carbohydrates. The liquid may be administered to the subject before, 15 minutes before, or 30 minutes before, which are times when the liquid is ready for digestion. This is based on the length of time it usually takes for blood to pass through the urinary system.

[0061] According to another aspect, the beverage compositions described herein can be used as a meal or snack replacement. As used herein, a meal or snack replacement refers to a solid food meal or snack. It is meant to be a complete meal or snack replacement and does not contain the nutritional value (macronutrients and micronutrients) of a typical complete meal / snack. The purpose of the present invention is to provide a range of nutritional and nutrient profiles, both in terms of nutritional value and nutritional value.

[0062] According to another aspect, the beverage compositions described herein may be used to improve cognitive function by activating type II To manage and / or treat diabetes, to reduce postprandial blood glucose, to promote weight loss to promote cardiovascular health and / or improve body mass index, thereby reducing the risk of cardiovascular disease and / or to prevent the risk of hypoglycemia due to a blood glucose-induced insulin response. In one embodiment, the active ingredients are polyphenols and In one embodiment, the beverage compositions described herein are intended to be effective in treating high blood sugar levels. subjects who are concerned or have become concerned about their blood sugar levels, subjects who are concerned about body fat, and It can be used for obese subjects, subjects prone to metabolic syndrome, etc. can.

[0063] The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, These specific forms or means for performing the disclosed functions or disclosed Where appropriate, these are expressed in terms of methods or processes for achieving results, but these are separate individually or in any combination of such features to realize the invention in diverse forms thereof. It can be used for.

[0064] While the present invention has been described in connection with the exemplary embodiments set forth herein, it will be apparent to those skilled in the art that various modifications may be made thereto. Many equivalent modifications and variations will be apparent in light of this disclosure. The exemplary embodiments of the present invention described above are considered to be illustrative and not limiting. Various modifications to the described embodiments may be made without departing from the spirit and scope of the invention. Changes can be made.

[0065] For the avoidance of doubt, the theoretical explanations provided herein are for the purpose of enhancing the understanding of the reader. The inventors do not wish to be bound by any of these theoretical explanations. do not have.

[0066] The section headings used herein are for organizational purposes only and It should not be construed as limiting the subject matter described.

[0067] Throughout this specification, including the claims that follow, unless the context otherwise requires: The words "comprise" and "include" and "contain (comprises), "comprising" and "including Variations such as "using" are not to be confused with the integer or step or integers or steps listed. any other integer or step or group of integers or steps. It is understood to imply that it is not excluded.

[0068] As used in this specification and the appended claims, the singular forms "a," "an," and "an" are used interchangeably. and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that ranges are expressed herein as "about" one particular value and Ranges may be expressed as "up to" and / or "about" another particular value. Where expressed, another embodiment may include a range from one particular value and / or to another particular value. Similarly, when values ​​are expressed as approximations, the use of the antecedent "about" does not imply an approximation of the particular value. It will be understood that the terms "about" in connection with numerical values ​​form another embodiment. It is optional and means, for example, + / - 10%.

[0069] The invention will now be described with reference to the following non-limiting figures, in which Figures 1-20 relate to Test 1. This is what is done. [Brief explanation of the drawings]

[0070] [Figure 1] The subject's assessment in Study 1 is shown below. [Figure 2] 1 shows mean glucose over time by treatment for the Intent to Treat population. [Figure 3] 1 shows mean insulin over time by treatment for the Intent to Treat population. [Figure 4] 1 shows mean C-peptide over time by treatment for the Intent to Treat population. [Figure 5] Shown are mean GIP over time by treatment for the Intent to Treat population. [Figure 6] Figures 6-11 show the mean liking ratings for the intent-to-treat group. Figure 6 shows the question, "How much did you enjoy the beverage?" (0 = not at all to 100 = very much). [Figure 7] The question asks, "How difficult was it to consume the given amount of fluid?" (0 = not difficult at all to 100 = very difficult). [Figure 8] The question asked was, "How did you perceive the taste of the beverage?" (0 = very bad to 100 = very good). [Figure 9] This question asks, "How bitter did you find the beverage?" (0 = not bitter at all to 100 = very bitter). [Figure 10] The question asked was, "How did you feel about the texture of the beverage?" (0 = unfavorable to 100 = favorable). [Figure 11] The question asked was, "Did you experience an aftertaste?" (0 = none to 100 = strong). [Figure 12] Figures 12-20 show mean ratings of mood and satiety over time by treatment in the Intent to Treat population. Figures 12-20 show mean ratings of mood and satiety over time by treatment in the Intent to Treat population. Figure 12 shows the question, "How happy do you feel?" (0 = not happy at all to 100 = very happy). In this figure, placebo is at the bottom line and fruit pulp is at the top at 60 minutes. [Figure 13]The question asks, "How alert do you feel?" (0 = not at all alert to 100 = very alert). In this figure, at 10 minutes, the placebo is at the middle line and the fruit pulp is at the bottom. [Figure 14] The question asks, "How hungry do you feel?" (0 = not hungry at all to 100 = very hungry). In this figure, at 30 minutes, the placebo is the bottom line and the fruit pulp is the middle line. [Figure 15] The question asks, "How satisfied do you feel?" (0 = not at all satisfied ~ 100 = very satisfied). In this figure, at 30 minutes, the placebo is at the middle line and the fruit pulp is at the top. [Figure 16] The question is: How lively do you feel? (0 = not at all to 100 = very lively) In this figure, at 60 minutes, placebo is at the bottom line and fruit pulp is at the top. [Figure 17] The question "How would you rate your digestive comfort?" is shown (0 = very uncomfortable to 100 = very comfortable). In this figure, at 60 minutes, the placebo and fruit pulp are at the top and the mixture is at the bottom. [Figure 18] The question asks, "How thirsty do you feel?" (0 = not at all to 100 = very thirsty). In this figure, at 10 minutes, the placebo is at the bottom line and the fruit pulp is in the middle. [Figure 19] The question is: How much do you think you can eat? (0 = not at all to 100 = a lot). In this figure, at 30 minutes, the placebo is at the bottom line and the fruit pulp is in the middle. [Figure 20] The question is: How strong is your appetite? (0 = not at all ~ 100 = very strong). In this figure, at 60 minutes, placebo is the bottom line and fruit pulp is the top line. In the above figure, the error bars represent the standard error. [Example]

[0071] The invention will now be described with reference to the following non-limiting examples.

[0072] Test 1 Tests were conducted to confirm the effects of the composition of the present invention on clinical trial participants. The following abbreviations were used:

[0073] [Table 1]

[0074] Postprandial blood sugar refers to the transient rise in blood sugar levels that occurs after eating a meal. When large fluctuations are experienced frequently, pancreatic beta cell function declines, and therefore type 2 diabetes This increases the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease ( Blaak et al., 2012 ).

[0075] Drinking a drink containing fruit polyphenols immediately before a meal reduces blood sugar levels It has previously been shown that the rate of reported that the intake of beverages containing blackcurrant and / or apple polyphenol extracts reduces the risk of pulmonary embolism after meals. favorably altered carbohydrate absorption ( Acosta et al., 2016 ).

[0076] Fruit polyphenols inhibit digestive enzyme activity and the sodium-glucose cotransporter 1 (S Reduced GLT-1 / GLUT-2 glucose transporter activity (Will iamson, 2013 ), or possibly by binding to starch molecules ( Shen et al., 2012 ). It slows down glucose absorption. Importantly, other fruit components, namely soluble fiber, also contribute to the absorption of glucose in the stomach. It slows down the rate of excretion (Di Lorenzo et al., 1988), interacts with the intestinal mucus layer, and It also affects carbohydrate digestion by affecting starch hydrolysis by enzymes (Grundy, 2016). The addition of both polyphenols and fiber to beverages may affect the It remains unclear whether there is an additive or synergistic effect on post-hyperglycemia reduction. However, there is growing evidence of beneficial acute effects of polyphenols on cognitive function. Many workplace and academic environments where rapid cognitive enhancement is desired to perform a task or test It has attracted considerable interest in the field (Bell et al., 2015).

[0077] The purpose of this study was to evaluate postprandial outcomes after a mixed carbohydrate (starch and sucrose) test meal. Investigating the effect of fruit polyphenol extracts combined with pulp (a fiber source) on The primary endpoint was glycemic response, and additional secondary endpoints were cognitive performance. Test, postprandial plasma insulin, gastrointestinal hormones closely related to the rate of glucose absorption, and and the incretin glucose-dependent insulinotropic peptide (GIP), and C-peptide (co-secreted with insulin after a meal, a more precise indicator of insulin secretion rate) Also included were perceived satiety, subjective mood, and appropriate energy intake. The study utilized a randomized, double-blind, crossover design. Each subject , placebo drink (no polyphenols or fiber), pulp-only drink (1 fiber 0.5g), and BC extract drink combined with pulp (total polyphenols 800ml g and 1.5 g of fiber) were ingested at three separate study visits. Postprandial changes in urea, GIP, and C-peptide concentrations were measured. It was hypothesized that pectin fiber supplementation would reduce postprandial blood glucose compared to placebo, and the effect of pectin fiber A drink containing pulp alone was used to evaluate

[0078] 2. Test Purpose 2.1 Main purpose The primary endpoint was the iAUC of plasma glucose. 0-30min This is the baseline It is defined as the change in the area under the curve of the plasma glucose concentration of the sample from 0 min to 30 min.

[0079] 2.2 Secondary Objectives 1. iAUC of plasma glucose concentration 0-150min . 2. iAUC of plasma insulin, C-peptide, and GIP concentrations 0-30min and i AUC 0-150min . 3. Plasma, defined as the maximum change from baseline over the 150-minute sampling period Incremental C of glucose, insulin, C-peptide and GIP concentrations MAX (I C MAX ) . 4. Plasma glucose, insulin, C-peptide and and GIP's T MAX . 5. At each time point (T10, 20, 30, 45, 60, 75, 90, 120, and 150 min) Plasma concentrations of glucose, insulin, C-peptide and GIP in the rats. 6. Preference questions using VAS at T10 and T230 minutes, and T-10, 1 Mood and satiety questions at 0, 30, 60, 90, 120, and 150 minutes Responses will be summarized using descriptive statistics. 7.Appropriate amount of energy replenishment at T215 minutes. 8. Cognitive testing scores at baseline (T-45) and endpoint (T165) Core. The software platform Computeri is used to perform cognitive tasks. sed Mental Performance Assessment System (COMPASS, Northumbria University, Newcastl e Upon Tyne, UK). This assessment is based on the results of Jackson 2012. These are presented in the same order as outlined below, with brackets indicating Cognitive domains are described. All reaction times are measured in milliseconds and accuracy is measured in percent correct. Measured as percentages. a) Choice reaction time (attention / response inhibition). Arrows pointing left and right were displayed on the screen. In the task, participants pressed the "Z" (left) or "M" (right) key corresponding to the direction of the arrow. The inter-stimulus interval was randomly varied between 1 and 3 seconds, for a total of 50 Stimuli were administered, and accuracy and mean reaction time were recorded. b) Rapid Visual Information Processing (RVIP, cognitive performance / working memory): Participants completed a series of rapid (1 min) Three consecutive odd or even numbers from the single-digit numbers (1-9) presented in a sequence of 100 numbers Each time you find a number, you can answer by pressing the "space bar" on your laptop keyboard. The accuracy (percentage of correct detection of the target string) and the time required for a correct response were The mean reaction time and number of false alarms were recorded. c) Simple reaction time (psychomotor speed / attention): Participants were asked to respond to an up arrow appearing on the screen. Every time you press the space bar on your laptop keyboard, you need to press it as quickly as possible. Stimuli were presented with inter-stimulus times that varied randomly between 1 and 3.5 seconds. The reaction time was recorded. d) Stroop task (attention / response inhibition): Conclusion of the Stroop task (Stroop 1992). A series of color words (green, blue, red, yellow) are presented in a series of letters of different colors. The stimuli were presented randomly (e.g., red was presented with yellow letters, etc.). Participants were asked to fill in the color boxes on the right side of the screen that matched the color of the letters in the word. Participants were asked to click the button. Accuracy, mean reaction time, and number of false alarms were recorded. e) Four-choice reaction time (attention). A visual representation of the four-way arrow keys of a standard keyboard was displayed on the screen. Arrows were randomly "lit up" on the screen and participants were asked to press the corresponding arrow key. Overall, each arrow represented 12 target stimuli, for a total of 48 stimuli. Accuracy and mean reaction time were recorded. f) Consecutive 3 Subtractions (cognitive ability / working memory): Participants completed 800- Starting with a randomly generated first number between 999, subtract 3 consecutively as quickly and accurately as possible. Pressing the "Enter" key erased the answer and participants were asked to They were shown only the first number, and then had to continue subtracting from memory. If a question is answered incorrectly, subsequent answers that are correct in relation to the new number will be scored positively. Correct and incorrect answers, as well as errors, were recorded.

[0080] 3 Clinical trial planning 3.1 Description of overall study design and plan A randomized, placebo-controlled, double-blind, crossover study was conducted over three separate visits. All subjects received three drinks: placebo, pulp only, and BC + pulp drink. BC+ Pulp Drink provides 800mg of total polyphenols (TP) It contains a combination of BC extract and fruit pulp providing 1.5g of fiber. Patients will be randomly assigned to one of the treatment arms.

[0081] The minimum washout period was at least 4 days. When possible, study visits were scheduled 21 days or more apart. To minimize the influence of cyclic reproductive hormones in female subjects, Elephants participated in the study visits only during the middle two weeks of their menstrual cycle (weeks 2 and 3), and only during the first week ( They did not participate in the first week (week 1) or the last week (week 4).

[0082] Standardized dietary and exercise instructions were given before the visit (source data). After an overnight fast, participants were given a low-polyphenol / low-fiber diet for 48 hours, followed by a 24-hour The subjects continued to eat a low-fat diet and had no caffeine or decaffeinated tea or coffee since noon the previous day. To avoid heatstroke, subjects arrived between 8:00 and 10:00 AM for each study visit. After the patient completed a cognitive battery test (approximately 30 minutes), a forearm vein was cannulated. Two baseline fasting blood samples were taken (T-10 and -5 min). After the intake of the sucrose (T0 min), a high-carbohydrate meal (starch and sucrose) was provided ( White bread and apricot jam). Plasma glucose analysis, serum insulin, c-peptide and G For IP, T10, 20, 30, 45, 60, 75, 90, 120 and 150 minutes After the meal, blood was collected. Then, the cannula was removed 150 minutes later, and the subjects were asked to undergo a 30-minute cognitive The battery test was repeated, followed by an ad libitum pasta meal (T-2 15 min). At 30, 60, 90, 120, 150 and 230 minutes, the palatability, satiety and They completed a visual analog scale (VAS) questionnaire regarding their mood and other subjective feelings.

[0083] 3.2 Rationale for study design, including choice of control group The randomized, placebo-controlled, double-blind study design is the gold standard in human clinical trials This study was conducted in a complete crossover design. It was predicted that the absorption rate of glucose would be slowed down, and therefore the early postprandial glucose concentration (iAU) C 0-30min ) was selected as the primary outcome. The most important changes in postprandial blood glucose and insulinemia after a hydrated meal, as well as C-peptide and The study was chosen to allow observation of the subsequent changes in GIP and IL-1 levels. Following a previous similar study, a starch / sucrose test meal of white bread and apricot jam was conducted. This allowed for comparison between studies.

[0084] 3.3 Selection of study population The study population consisted of healthy men and women aged 18 to 70 years from the general adult population. The target is advertising (posters within KCL, internal email circulation, social media [Facebook] Recruitment was conducted using external advertising, including [Google, Twitter, and newspaper ads] (funding Subjects who met the inclusion criteria after the pre-screening telephone questionnaire were enrolled in the first trial. The subjects were admitted to the Metabolic Research Unit (MR) at least 1 week prior to the study visit. U), Franklin-Wilkins Building, King's Coll. I was invited to attend a screening visit in London. In the study, written informed consent was given, followed by blood pressure and anthropometric data. The participants' data (height, weight, waist and hip circumference, and body fat percentage) were measured and fasting was performed. Blood samples were taken at baseline and assessed for exclusion criteria. Subjects also completed a cognitive battery test. A dry run of the inclusion and exclusion criteria (sections 3.3.1 and 3.3.2) was also conducted. Subjects admitted to the study according to the dietary guidelines (see [link to original source]) completed a 7-day food diary. Completed and recorded habitual food intake.

[0085] 3.3.1 Inclusion criteria 1.Agree understanding and participation in the study as evidenced by voluntary written informed consent and willingness to participate and provide a signed and dated copy of the informed consent form. I am receiving it. 2. Age Be over 18 years old and under 70 years old as of the date of enrollment. 3. Compliance Willing, able, and able to understand and comply with all testing procedures and limitations there was. a. Subjects were willing to comply with the dietary instructions for participants. b. Subjects were willing to avoid strenuous exercise for 24 hours prior to each study visit. c. Subjects were willing to avoid caffeine during the day prior to each study visit. d. For female subjects only: Subject provided the approximate start date of their menstrual cycle. 4. General health Subjects must be in good general and mental health and, in the opinion of the investigator, a) No clinically significant and relevant abnormalities in the history or physical examination. b) Affecting the safety or well-being of subjects or study procedures and requirements There are no conditions that affect an individual's ability to understand and comply.

[0086] 3.3.2 Exclusion criteria 1. Intolerance / Allergy / Hypersensitivity known or known compounds for the test substance (or closely related compounds) or any other described component. those with suspected intolerance or hypersensitivity. 2. Blood donation a) Those who have donated blood within 3 months of the screening visit date. b) Participating in this study means you have donated more than 1500 ml of blood in the past 12 months. Someone who has become like that. 3. Participation in clinical trials a) Concurrent participation in another clinical trial b) Previously participated in this clinical trial 4. Smoking a) Current smokers or e-cigarette users b) reported having quit smoking within the past 6 months. 5. Weight loss Those who have experienced weight loss of more than 3 kg (7 lbs) in the past 2 months. 6. Alcohol consumption Consuming more than 28 units of alcohol per week (men) or 21 units per week (women) The one who did it. 7. Concomitant medications Alpha-glucosidase inhibitors (acarbose: Glucobay), insulin resistance Sexual enhancement drugs (metformin: Glucophage, Glucophage SR, Euc reas, Janume; Thiazolidinedione: Actos, Competact) Sul Honyl urea (Daonil, Diamicron MR, Glibenese, Mino diab, Amaryl Tolbutamide), and lipid-lowering drugs (statins, may interfere with the test (e.g., cobalamin, anhydrous cholestyramine, ezetimibe, fibrates). Other medications were reviewed by KCL medical personnel on a case-by-case basis. . 8. Nutritional Supplements High-dose vitamins / minerals (RNI>200%), vitamin B, vitamin C, calcium , copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc, etc. Nutritional supplements that may interfere with the test. Approximately 100% to 20% of the RNI. Vitamin or mineral or evening primrose / algae / fish oil supplements at doses up to 0% Subjects already taking the drug should maintain their regular supplementation pattern and ensure daily, rather than sporadic, supplementation. They were also asked not to stop taking the supplements during the study period. They were advised not to take any other medications or start any new supplements. 9. Medical History Those with a history of the following: a) Phenylketonuria b) Heart attack (myocardial infarction) or stroke c) Cardiovascular problems / angina / thrombosis d) Cancer within the past 5 years e) Diabetes mellitus (type 1 or type 2) f) gastric or inflammatory bowel disease g) Kidney problems h) Liver disease, adult jaundice or anemia i) History of drug and / or alcohol addiction (>60 units / week) 10. Women's Health a) Pregnancy: subjects who are known to be pregnant or who plan to become pregnant during the study period b) Breastfeeding: women who are currently breastfeeding or lactating Exclusion criteria assessed after measurements are taken -Those whose mean blood pressure reading is ≥ 160 / 100mmHg Body mass index <18 or >35 kg / m 2 Those who are -Persons who are unable to collect fasting venous blood samples -Those whose complete blood count and liver function test results are outside the normal range. Total cholesterol ≥ 7.5mmol / L; fasting triacylglycerol concentration ≥ 5. Those with a blood glucose level of 0mmol / L

[0087] 3.3.3 Subject Restrictions 3.3.3.1 Lifestyle Screening: Subjects were advised to avoid eating or drinking anything other than water after 8 PM the night before. .

[0088] Study: Subjects were to avoid high-fiber and high-polyphenol foods for 48 hours prior to the study visit. They were also asked to change their diet to avoid fatty foods, oily fish and Avoid alcohol and alcohol, refrain from participating in any strenuous exercise for 24 hours before the study visit, and Subjects were asked to abstain from caffeine from noon on the day of the visit. Instructions were provided (source data). Subjects were also instructed to refrain from eating or drinking anything other than water after 8:00 PM the day before each visit. During the study visit, subjects were asked to avoid Other than walking short distances between the Unit's examination rooms, the patient remains seated for the entire visit (approximately 3 hours). I was asked to stay until.

[0089] 3.3.3.2 Drugs and Treatments Subjects were not permitted to take any of the medications prohibited by the exclusion criteria during the study period. If a subject is prescribed such medication during the study, the subject will be withdrawn from the study. .

[0090] 3.3.4 Exclusion of Subjects from Treatment or Evaluation Subjects have the right to withdraw from the study at any time for any reason. They were able to extract their data from the study until

[0091] The investigator may report any intercurrent illnesses, adverse events (AEs) or product failures following a given procedure, The right to withdraw a subject from the study in the event of protocol deviation, administrative reasons, or other reasons. had an advantage.

[0092] If a subject decides to withdraw from the study, they should complete and report the observations as fully as possible. Every effort was made to ensure that a complete final evaluation was performed at the time of subject withdrawal. This was accompanied by an explanation of the reasons for withdrawal.

[0093] 3.4 Treatment 3.4.1 Actions taken The LRS new product development team conducted placebo, fiber only, and polyphenols and Three different treatments were provided, including a drink containing 200ml of water and fiber. The test drinks were formulated as follows:

[0094] [Table 2]

[0095] 3.4.2 Investigational Product Identification 3.4.2.1 Test Drink Identification BC polyphenol extract was supplied by BerryPharma, Iprona BC polyphenol extract is delphinidin-3-rutinoside (spectrophotometric, pH Anthocyanins (expressed as a function of the difference method) were measured at 20.0 to 28.0 g / kg, and 25.0 to 55.0 g of polyphenols expressed as quinone (Folin-Ciocalteuth) Contains / kg.

[0096] Fruit pulp is Citresa, Orangina Schweppes Sunto Supplied by Citricos Y Refrescantes, Spain Ta.

[0097] 3.4.2.1 Test Breakfast Identification The subjects were both on a high-carbohydrate diet low in phenolics (<6 mg / 100 g fresh weight). Approximately 100g of thick-sliced ​​white bread (Hovis, London, UK) and 32g Hartley's smooth apricot jam (Hain Danie ls Group, Leeds, UK) were fed a starch / sucrose mixed diet. These were typical meal serving sizes and were well tolerated by the subjects. The total amount of carbohydrate provided in the meal and test drink was approximately 75 g. Notably, this is the same amount of carbohydrate (75g) used in a 2-hour oral glucose tolerance test. Jam must be refrigerated, labeled with the date of opening and the Glu-MIX test, and stored for no longer than six weeks after opening. Bread was purchased and frozen on the day of purchase during off-peak weeks to prevent mold growth. The bread was thawed in time for breakfast. The bread packaging contained Glu- The test mix was labeled with the test mix and date. Clean utensils and A sanitized work surface was used. The bread was weighed on a plate and the jam was spread evenly on the bread. Ta.

[0098] 3.4.3 Treatment Allocation For a 3 × 3 crossover study, the randomization schedule was a Williams square. Within the randomization list, each subject was assigned to receive placebo during one of the study periods. In addition, pulp-only and test (BC + pulp) drinks were assigned to the other study periods. Furthermore, each treatment is followed by the same number of all other treatments.

[0099] 3.4.4 Dose Selection for the Study Based on previous study results (HVS-007, GLU-FX), a total PP dose of 800 mg was used. was selected, and in this study, an 800 mg TP dose of BC was shown to reduce iAU in the first 30 minutes after a meal. It was found that the fiber content of cereals containing ... 3g / 100kcal), so 0.75g / A fiber concentration of 100 ml was chosen. The pectin in the drink comes from the pulp.

[0100] 3.4.5 Dose Selection and Timing for Each Subject All subjects received three drinks according to a double-blind randomization schedule. One drink was administered per study visit. Study visits were conducted over a minimum of 4 days, as long as possible. If the washout period is less than 21 days, this is considered sufficient for an acute study. .

[0101] The test drinks were used to mask slight differences between the treatment drinks in terms of color and flavor. Each drink was served in a clear brown glass bottle with a black straw. Before the study visit, the subjects were removed from the freezer, placed in the refrigerator, and allowed to thaw for 48 hours. The test drinks were removed from the refrigerator approximately 10 minutes before serving to the subjects. Vortex for another minute to ensure the drink was completely dispersed. Just before providing the drink, the researchers also inverted the bottle 10 times. Just before serving the drink, the researchers thoroughly shaked it. A thin straw was inserted into the bottle. Subjects were given up to 2 minutes to consume the test drink. Subjects were then given 7 minutes to consume a mixed carbohydrate breakfast. They were asked not to tamper with the link bottle in any way.

[0102] 3.4.6 Blinding The study was double-blinded, and only independent consultant physicians determined the randomization schedule and treatment allocation. This blinding was maintained throughout the study and was resolved at the end of the study and at the time of analysis. was not removed.

[0103] 3.4.7 Treatment Compliance The researcher determined that the total volume of each test drink provided was within the allotted time (2 minutes). The empty bottles were kept on-site and were then inspected by the test monitors at the end of the test. We checked and checked for compliance.

[0104] 3.5 Demographic, Efficacy and Safety Variables, and Schedule of Study Events 3.5.1 Test Event Schedule The schedule of test events is presented in the table below. Details of each variable recorded are given in the table below. These are discussed in Sections 3.5.2 to 3.5.5, including

[0105] [Table 3]

[0106] 3.5.2 Demographics and patient characteristics All demographic and subject characteristics were entered into the CRF. Subject characteristics were recorded: year and month of birth, age, sex, and ethnicity. The following steps were completed: Height using a length meter, waist and hip circumference using a tape measure, TANITA BC -Body composition and weight measured by bioelectrical impedance using the 418 segmental body composition analyzer , blood pressure using an automated blood pressure monitor (A&D Medical). Allergies or food Data were collected regarding the subjects' relevant medical or surgical history, including intolerances. Supplementation data were obtained from a 7-day estimated food diary. Buccal cells were collected at the screening visit using the following: glucose, complete blood count, liver function A screening fasting venous blood sample was collected for analysis of the test and total lipid profile. Got it.

[0107] 3.5.3 Effectiveness Measurement and Evaluation The primary efficacy endpoint was significantly different for pulp and BC drink compared to placebo. A trial is considered successful if it is found that the The peak postprandial blood glucose concentration (iAUC0-30m) was significantly reduced by the test treatments (BC and pulp). The pulp-only drink was used to assess the effect of fiber alone.

[0108] 3.5.4 Safety Measurement and Evaluation An AE was considered treatment-emergent if it occurred after the first dose of one of the randomized treatments. The onset date was within the washout period between the study periods. All AEs during the study were assigned to the treatment received in the previous period. All AEs that began during Period 3 or the last treatment period before study end were associated with treatment. AEs with onset date / time before the first treatment dose were assigned to the treatment period. was considered non-treatment emergent.

[0109] Worsening of the intensity of consecutive AEs from one treatment / baseline period to the next If an AE occurred, it was considered to have occurred in the period in which it worsened.

[0110] 3.5.4.1 Adverse Events Adverse events (AEs) did not necessarily have a causal relationship to this treatment; Any adverse medical occurrence in the subject after administration.

[0111] AEs were recorded throughout the study. The investigator was responsible for any follow-up visits. At each visit, including the one in the previous section, subjects were asked the following question: "Did you feel unwell or experience any symptoms?" Have you had any medications (since last visit) (today) (since last dose) )(from the last session)”.

[0112] AEs were recorded on the CRF by diagnosis, rather than by symptom, when possible (e.g. (e.g., cold, not runny nose, seasonal allergies, etc.) The investigator will provide CRF with information on the severity and severity of the AE. The relationship between the study and the treatment was recorded. The strength and relationship ratings were as follows: ·Strength: - Mild - easily tolerated, causing minimal discomfort and not interfering with normal daily activities do not have. - Moderate - Discomfort enough to interfere with normal daily activities. - Severe - Disabling and / or interfering with normal daily activities. Relationship to test treatment: - Unrelated - The event is not related to the subject's clinical condition, therapeutic intervention, or concomitant medication administered to the subject It was clearly linked to other factors such as medication. - Unlikely - The event is not related to the subject's clinical condition, therapeutic intervention, or medication administered to the subject These findings are most likely caused by other factors, such as concomitant medications, and are not related to known response patterns to the investigational intervention. Did not follow turn. - Possible - The events follow a reasonable timeline from the time of drug administration, and / or or follows a known pattern of response to the investigational drug, but differs from the subject's clinical condition, therapeutic intervention, Or it may have been caused by other factors such as concomitant medications administered to the subject. - Possible - Events follow a reasonable chronology from the time of drug administration and and follow known patterns of response to the subject's clinical condition, therapeutic intervention, or It cannot be reasonably explained by other factors such as concomitant medications taken. - Likely - Events follow a reasonable chronology from the time of drug administration and are and follow known patterns of response to the subject's clinical condition, therapeutic intervention, or The symptoms cannot be reasonably explained by other factors, such as concomitant medications, and occur shortly after administration of the investigational drug. whether the symptoms were severe, improved with discontinuation of the drug, or recurred with repeated exposure; or a positive reaction occurred at the application site.

[0113] Furthermore, AEs were classified as serious or non-serious. Serious adverse events occurred at any dose: a) It resulted in death. b) It was life-threatening. Note: The term "life-threatening" in the definition of "serious" means that the subject is at risk of death at the time of the event. This term refers to an event that, if more severe, would hypothetically cause death. It does not refer to a possible event. c) Hospitalization or extension of existing hospitalization was necessary. NOTE: Generally, hospitalization is required for observation and / or treatment that would not be appropriate in a physician's office or outpatient setting. Subject was admitted to a hospital or emergency room (usually for at least one night) for a medical procedure or The complications that occurred during hospitalization were AEs. An event is considered serious if it is prolonged or if the complication meets any other serious criteria. An AE was considered serious if there was doubt whether hospitalization occurred or was necessary. It should have been. Hospitalization for elective procedures for pre-existing conditions that did not worsen from baseline was considered an AE. There wasn't. d) caused disability / incapacity; or Note: The term disability means a significant impairment of a person's ability to perform normal life functions. This definition is intended to include symptoms that may interfere with or hinder daily functioning, but are not substantial. uncomplicated headache, nausea, vomiting, diarrhea, influenza, and Including experiences of relatively minor medical significance, such as accidental injuries (e.g., sprained ankles). It wasn't intended. e) Congenital anomalies / birth defects Any adverse medical event.

[0114] Other situations, such as those that are not immediately life-threatening or likely to result in death or hospitalization, Potentially endangering the subject or one of the other outcomes listed in the definition above There were significant medical issues that may have required medical or surgical intervention to prevent one of the Medical or scientific judgment was used in determining whether reporting of an event was appropriate. These were also considered serious. Examples of such events include invasive or malignant cancer, allelic Emergency room or home intensive care for allergic bronchospasm, hematologic disorders not requiring hospitalization or the onset of seizures, drug dependence or drug abuse.

[0115] 3.5.4.2 Laboratory Evaluation Any abnormal outcome during the time period specified for AE reporting that the investigator deems clinically significant Any clinically significant abnormal laboratory findings must be recorded as an AE or SAE. If associated with a diagnosis, the diagnosis should be recorded on the CRF.

[0116] 3.5.4.3 Vital Signs and Other Safety Observations Any abnormal outcome during the time period specified for AE reporting that the investigator deems clinically significant Any clinically significant abnormal laboratory findings must be recorded as an AE or SAE. If associated with a diagnosis, the diagnosis should be recorded on the CRF.

[0117] 3.5.6 Primary Efficacy Variable iAUC 0-30min

[0118] 3.5.7 Drug concentration measurements Not applicable (not a drug trial, nothing was administered)

[0119] 3.5.8 Changes in Test Execution No changes were made in the conduct of the study.

[0120] 3.6 Data Quality Assurance Study monitors will audit CRFs at study sites according to the monitoring plan and review all CRFs. A white copy of the F was collected. A query was made to the investigator or designee and The data custodian was able to address the error before the audit. We reviewed the data and issued queries for clarification or correction of the facility.

[0121] 3.7 Data analysis method 3.7.1 Determining sample size Based on previous studies (HVS-007, GLU-FX), placebo and 800 mg The mean plasma glucose iAUC0-30 response in the BC group was 1.28 mmHg, respectively. ol / L and 1.05 mmol / L (i.e., a difference of 0.23 mmol / L). The within-subject standard deviation was 0.29. All three treatment periods demonstrated a difference of 0.23 mmol / L or approximately 18% compared to the control group. The 36 subjects who completed the study showed that pulp and BC polyphenols were significantly higher than those of the control group at a two-sided 5% significance level. This provides 90% power to detect a difference between the drink and placebo.

[0122] To allow for an attrition rate of approximately 5%, 38 subjects were randomized into the study.

[0123] 3.7.2 General Considerations for Data Analysis 3.7.2.1 Interim analysis No interim analyses were performed in this study.

[0124] 3.7.2.2 Handling of Dropouts or Missing Data Did not complete all four study periods, but data from at least one of the study periods are available A subject was included in the analysis when possible, as the subject was a random effect in the analysis. This was achieved by including

[0125] In calculating the AUC, if one value is missing during the evaluation period, the AUC is simply calculated based on the available If there was more than one missing value, or if any of the start or end values ​​were missing, If any were missing, AUC was not calculated for that subject / period combination .

[0126] Plasma concentration values ​​below the lower limit of quantitation (LOQ) were set to 1 / 2 LOQ for statistical analysis. This is done extensively to reduce the bias associated with excluding the LOQ value from the analysis. The LOQs for each of the secondary metabolites were determined prior to sample analysis. .

[0127] 3.7.3 Study population The safety population is defined as all subjects who are randomized and receive one of the study treatments. The all-gender population was used to summarize adverse events that occurred during treatment.

[0128] The Intention to Treat (ITT) population consists of patients who received at least one of the study treatments. defined as all subjects who have received a 24-hour period and have at least one post-baseline efficacy assessment The ITT population was the primary population for efficacy analyses.

[0129] The Per Protocol (PP) population is a subset of the ITT population. Subjects with significant protocol violations affecting the outcome were not included at the visit affected by the violation. The primary variable (glucose iAUC 0-30min ) , if there is a difference of more than 10% between the number of subjects in the ITT and PP populations, it is effective in the PP population. Conduct a gender analysis.

[0130] Descriptive statistics (number of subjects, mean, standard deviation, median, minimum and maximum values ​​for continuous variables, and (frequency and percentage for categorical variables) and demographic and baseline data Presented for.

[0131] 3.7.4 Efficacy Analysis and Statistical Methods Statistical analyses were performed using SAS version 9.4.

[0132] For each of the analyses described below, the assumptions of normality and homoscedasticity are assessed and, where appropriate, Data were transformed before analysis or nonparametric analysis was performed (Wilcoxon (Signed-rank test).

[0133] For all primary and secondary variables, in addition to the analyses described, descriptive statistics were used. Summarize and graphically display data. For parameters evaluated at repeated time points, Data displays include descriptive statistics over time and line graphs of means over time.

[0134] For all variables measured at -10 and -5 minutes, baseline was determined as two values. was calculated as the average.

[0135] All efficacy variables were based on the null hypothesis of no difference between the study treatment and placebo. The analysis was conducted against the alternative hypothesis that there was a difference between the test treatment and placebo. For all variables measured at 5 minutes, baseline was calculated as the mean of the two values. It was.

[0136] 3.7.4.1 Primary Efficacy Parameter The primary efficacy endpoint was the iAUC of plasma glucose. 0-30min and this is zero Change from baseline plasma glucose concentration versus time curve for sample times from T to T30 minutes iAUC is defined as the area under the sigma. iAUC was calculated using the trapezoidal rule. Results were expressed in the original units of measurement ( To convert back to mmol / L, the iAUC was divided by the total duration (30 min).

[0137] iAUC 0-30min were analyzed using a linear mixed model. The model terms were fixed Treatment group and period were fixed effects, subject as a random effect, and subject level as a covariate. Included were baseline glucose levels and period levels.

[0138] The null and alternative hypotheses are: H0:iAUC 0-30min of all treatment pairs (including placebo) measured by There are no numerical differences in the comparisons (including all pairs). H1:iAUC 0-30min of several pairs of treatments (including placebo) measured by There is a numerical difference between all pairs (including It was.

[0139] From the above model, for all comparisons between placebo and test treatment, the D for the two-sided treatment comparison A Dunnett's test was performed. Treatment differences were evaluated with Dunnett's adjusted 95% confidence intervals. Assumptions of normality and homoscedasticity were considered. Violations of these assumptions were favorably reported. This can be overcome by using appropriate transformations or by performing non-parametric tests. Ta.

[0140] 3.7.4.2 Secondary Efficacy Parameters Secondary endpoints were: iAUC of plasma glucose concentration 0-150min . Plasma insulin, C-peptide (a more specific measure of insulin secretion), and GIP iAUC of concentration 0-30min and iAUC 0-150min . Group I, defined as the maximum change from baseline over the 120-minute sampling period Incremental Cmax (iCmax) of glucose, insulin, C-peptide and GIP concentrations. · Tmax of plasma glucose, insulin, C-peptide and GIP concentrations. At each time point (T10, 20, 30, 45, 60, 75, 90, 120 and 150 min) Plasma concentrations of glucose, insulin, C-peptide and GIP in patients with rheumatoid arthritis. Preference was assessed at T10 and T230 using a 100mm VAS questionnaire. The answer is: -T-10, 10, 30, 60, 90, 120 using a 100mm VAS questionnaire and responses to mood and satiety questions at 150 minutes. At the end of each treatment period, an appropriate amount of pasta was consumed, determined from the total amount of pasta consumed over the three sessions. Energy replenishment amount It was.

[0141] iAUC, iCmax and Tmax parameters were calculated using the same mixed model as the primary endpoint. or analyzed using non-parametric methods. The concentration of each parameter over time was , summarized using descriptive statistics and plots.

[0142] Responses to the VAS questionnaire were summarized using descriptive statistics over time and by treatment group.

[0143] Adequate energy intake and cognitive test scores were evaluated using the same linear mixed model as the primary endpoint. The data were analyzed using parametric or nonparametric methods.

[0144] 3.7.5 Safety parameters Adverse events are defined in the ICH Medical Dictionary for MedDRA System Organ Class A two-level hierarchical structure (Level 1) corresponds to the classification of "basic words" (Level 2) and level 2 terms) were coded by the sponsor's medical personnel. Concomitant treatment with treatment-emergent AEs according to Level 1 and Level 2 coded terms The incidence and percentage of AEs are presented by treatment group. A summary of relevant and serious AEs will be presented.

[0145] No statistical comparisons were made regarding the occurrence of AEs between treatment groups.

[0146] 3.7.6 Planned Analysis Changes The only modification to the protocol was to ensure that most of the pulp was incorporated. Once participants had finished, they added 20 ml of water to all drinks and shook them. This change came into effect on August 7, 2018.

[0147] 4. Test Subjects 4.1 Breakdown of targets 58 volunteers who met the initial eligibility criteria assessed by questionnaire were enrolled in the Ki attended a screening visit at ng's College London, of which 2 0 did not meet the inclusion criteria. 38 participants were randomized to treatment, 37 The test was completed (see Figure 1).

[0148] 4.2 Protocol Deviations There were no protocol deviations.

[0149] 4.3 Analyzed Dataset The entire data set was analyzed in the intention-to-treat population.

[0150] 4.4 Demographics and other baseline characteristics 4.4.1 Demographics Demographics of the intention-to-treat population are shown in Table 3.

[0151] 4.4.2 Baseline characteristics Baseline characteristics and baseline emptying of the intention-to-treat population Abdominal plasma levels are shown in Tables 4 and 5, respectively.

[0152] 4.4.3 Current and past medical disorders Medical histories were recorded in a database, but no data summaries were produced.

[0153] 4.5 Concomitant medications Concomitant medication use was recorded in the database, but no data summaries were produced.

[0154] 4.6 Compliance Except for two subjects in the BC + pulp and placebo groups and three in the pulp-only group, Subjects adhered to the study protocol for the test drinks and meals (Table 6). One subject The amount of drink spilled was estimated to be 10-20 ml. Two subjects were assigned to eat the test food. The time limit for installation was slightly exceeded.

[0155] 5. Efficacy Results 5.1 Primary efficacy parameters Glucose iAUC 0-30min The results are summarized in Tables 7.1 and 7.2. The pulp drink was found to be significantly better than both the placebo and the pulp-only drink in the first 30 minutes after eating. The rate of increase in plasma glucose during the 2-minute period was significantly suppressed (iAUC 0-30min average Difference [95% CI] BC + pulp vs. placebo, -0.16 mmol / L [-0.27, -0 .05]; and BC + pulp vs. pulp alone, −0.21 [−0.32, −0.10]). However, no such effect was observed in the pulp-only drink compared to placebo. It was.

[0156] 5.2 Secondary Efficacy Parameters 5.2.1 iAUC of plasma glucose concentration 0-150min Glucose iAUC 0-150min The results are summarized in Tables 7.3 and 7.4. UC 0-150min The baseline plasma glucose level during the 150-minute postprandial period was assessed by There was no effect of drink on change from Sline.

[0157] 5.2.2 iAUC 0-30min and iAUC 0-150min plasma insulin, C-peptide and GIP concentrations

[0158] 5.2.2.1 Insulin Insulin iAUC 0-30min and iAUC 0-150min The results are shown in Table 8.1 and summarized in Table 8.2. BC+pulp drink was compared with placebo and pulp-only drink. significantly reduced the rate of increase in plasma insulin during the first 30 minutes after a meal compared with both (iAUC 0-30min Mean difference [95% CI] BC + pulp vs. placebo, -2.6 7 mU / L [-4.70, -0.34]; BC + pulp vs. pulp alone, -5.21 [-7 .55, -3.02). The pulp-only drink had a significant effect on the placebo. Although no effect of fruit pulp was observed, there was a tendency for increased first-phase insulin secretion after fruit pulp. Ta. iAUC 0-150min Plasma insulin during the 150-minute postprandial period as assessed by There was no effect of drink on the change from baseline in

[0159] 5.2.2.2 C-peptide C-peptide iAUC 0-30min and iAUC 0-150minThe results are shown in Table 9. 1 and 9.2. iAUC 0-30min and iAUC 0-150min Each is evaluated by During both the first 30 minutes and the 150 minutes after eating period, the BC+pulp and placebo There were no significant differences in the change from baseline in plasma C-peptide between the groups. Peptide secretion was significantly reduced after BC + pulp compared with pulp alone during the first 30 min. No significant effect of the pulp-only drink was observed compared to the placebo. However, there was a tendency for increased secretion of C-peptide during the first 30 min after fruit pulp.

[0160] 5.2.2.3 GIP iAUC of GIP 0-30min and iAUC 0-150min The results are shown in Table 10.1 Both the BC+pulp and pulp-only drinks were significantly higher than placebo. During the first 30 minutes after eating, the mean area under 0-30min Mean difference [95%CI] BC + pulp vs. placebo, −36.26 ng / L [(−49.23, −23.23]; rup vs placebo, -11.22 [-22.31, -0.00]); and 150 min after a meal During the period (iAUC 0-150min Mean difference BC + pulp vs. placebo [95% CI] -28 The rate of increase in plasma GIP (0.62 ng / L [-47.99, -6.17]) was significantly suppressed. Pulp alone had a significant effect on iAUC 0-150min The effects of the drink can be seen iAUC 0-30min and iAUC0 -150min The increase in GIP was significantly attenuated in both groups (mean difference [95% CI] -29.06 [-41.69, -15.46] and -21.08 [-41.29, -1 .91]).

[0161] 5.2.3 Glucose, insulin, C-peptide, non-esterified fatty acids and GIP Concentration iCmax

[0162] 5.2.3.1 Glucose The glucose iCmax results are summarized in Tables 11.1 and 11.2. There was no effect of drink on maximum change in glucose from baseline over the period.

[0163] 5.2.3.2 Insulin The insulin iCmax results are summarized in Tables 12.1 and 12.2. There was no effect of drink on maximum insulin change from baseline over the period.

[0164] 5.2.3.3 C-peptide The C-peptide iCmax results are summarized in Tables 13.1 and 13.2. There was no effect of the drink on the maximum change in C-peptide from baseline during the Ta.

[0165] 5.2.3.4 GIP The GIP iCmax results are summarized in Tables 15.1 and 15.2. There was no effect of drink on the maximum change in GIP from baseline during the There was a non-significant trend towards reduction after BC+pulp relative to Sebo.

[0166] 5.2.4 Tmax of Plasma Glucose, Insulin, C-Peptide, and GIP

[0167] 5.2.4.1 Glucose The glucose iTmax results are summarized in Tables 15.1 and 15.2. There was no significant difference in the time to reach maximum concentration (Tmax) for BC+pulp compared to placebo. Tmax was significantly lower with polyphenols + fruit pulp compared to fruit pulp alone. The median (95% CI), 7.5 (7.50, 15.00) and Tmax were The mean mean mean time to presentation was significantly shorter with the fruit pulp drink compared with placebo (median (95% CI, -7 .5(-12.50, 0.00)).

[0168] 5.2.4.2 Insulin The insulin iTmax results are summarized in Tables 16.1 and 16.2. There was no effect of the drink on the time to reach maximum concentration.

[0169] 5.2.4.3 C-peptide C-peptide iTmax results are summarized in Tables 17.1 and 17.2. C-peptide There was no effect of drink on the time to reach maximum concentration.

[0170] 5.2.4.4 GIP The GIP iTmax results are summarized in Tables 18.1 and 18.2. There was no effect of drink on arrival time.

[0171] 5.2.5 Plasma concentrations of glucose, insulin, C-peptide and GIP over time

[0172] 5.2.5.1 Glucose Postprandial changes in plasma glucose after the test drink and a standard carbohydrate meal are shown in Figure 1. Compared to placebo, at 20 and 30 minutes after BC + pulp drink (from baseline The mean difference [95% CI] of the change in β-glucan was −0.27 [−0.47, −0.07] and − 0.27 [-0.52, -0.02]), as well as after the pulp-only drink at 120 minutes. (Mean difference [95% CI] of change from baseline -0.32 [-0.62, -0.02 ]) There was a statistically significant decrease in glucose levels at 10, 20, and 30 minutes. Glucose concentrations decreased (from baseline to The mean difference in change [95% CI] was −0.11 [−0.20, −0.02] and −0.3, respectively. 7 [-0.57, -0.17] and -0.30 [-0.55, -0.04]).

[0173] 5.2.5.2 Insulin Postprandial changes in insulin after the test drink and a standard carbohydrate meal are shown in Figure 2. Statistically significant increases in insulin concentrations after BC+pulp drink at 30 minutes compared to Sebo decreased (mean difference [95% CI] of change from baseline -8.25 [-13.16, - 2.39]), and insulin concentrations increased after pulp alone at 20 minutes (from baseline to The mean difference in the change in the 10-20 At 10 and 30 minutes, insulin concentrations were decreased after BC + pulp compared to pulp alone (Benefit The mean difference [95% CI] of change from baseline was -2.31 [-4.23, -0. 59], -7.14 [-11.12, -3.89] and -8.04 [-13.41, - 4.60]).

[0174] 5.2.5.3 C-peptide Postprandial changes in C-peptide after the test drink and a standard carbohydrate meal are shown in Figure 3. There was no significant difference in C-peptide concentrations after BC + pulp drink compared to placebo. C-peptide concentrations at 0 min were significantly increased after pulp alone compared with placebo (Benefit 1). The mean difference in change from baseline [95% CI] was 0.12 [0.02, 0.22]. , at 20, 30 and 45 minutes after the BC + pulp drink compared to the pulp-only drink C-peptide concentrations were significantly reduced in the 24-week period (mean difference [95% CI] change from baseline). -0.15 [-0.25, -0.07], -0.31 [-0.47, -0.17], respectively ], -0.36 [-0.61, -0.15] and -0.26 [-0.46, -0.02 ]).

[0175] 5.2.5.4 GIP Postprandial changes in GIP after the test drink and a standard carbohydrate meal are shown in Figure 4. Compared with BC + pulp drink at 10, 20, and 30 minutes (from baseline) Mean difference in change [95% CI] -12.86 [-25.21, -3.91], -61.96 [-85.35, -42.39], and -62.12 [-87.0, -37.86]). , as well as after the pulp-only drink at 30 minutes (mean difference in change from baseline [95 %CI]-22.82 [-45.20, -0.67]) GIP concentrations were statistically significantly lower Also, at 20 and 30 minutes, GIP concentrations were significantly lower after BC + pulp compared to pulp alone. were significantly reduced (mean difference in change from baseline [95% CI] -55.6 and -59.6, respectively). 7 [-74.69, -34.10] and -44.23 [-67.79, -20.44] ).

[0176] 5.2.6 Preferences The average preference ratings for the intention-to-treat group are shown in Figures 6 to 11. No significant differences were found between these ratings.

[0177] 5.2.7 Mood and satiety Mean ratings of mood and satiety in the intention to treat group were shown. 12-20. No significant differences were found in these ratings.

[0178] 5.2.8 Energy supplement amount The results for appropriate energy supplementation are summarized in Tables 19.1 and 19.2. There was no significant treatment effect on feeding.

[0179] 5.2.9 Cognitive function The cognitive test results are summarized in Tables 20.1–20.6. The response time to a four-choice reaction time task, a measure of strength, was 42 ms longer than placebo. The mean difference [95% CI] was -41.89 [-97.18, -4.64]. BC+pulp drink performed significantly better than placebo and 3-point serial subtraction (a measure of working memory). and pulp alone (mean difference [95% CI] -1 .0 [-2.0, 0.0] and -1.0 [-2.0, -0]). Simple reaction time, RVI Significant treatment effects on P (rapid visual information processing), simple reaction time, and the Stroop task There was none.

[0180] 5.3 Relationship between drug dose, drug concentration, and response N / A

[0181] 5.4 Aggregation of individual response data No target data list was created.

[0182] 5.5 Efficacy Conclusions The primary efficacy analysis was iAUC of postprandial blood glucose 0-30 Based on BC+ Pulp Drink Thus, efficacy was achieved, and the rate of increase in plasma glucose was significantly suppressed. The differences are small and have limited relevance to glycemic control.

[0183] 6. Safety Assessment 6.1 Degree of exposure Each subject received a single dose of each test product. Under the conditions of this study design, no harm was done to study participants. is not expected to reach

[0184] 6.2 Adverse Events (AEs) 6.2.1 Brief summary of adverse events A total of seven treatment-emergent adverse events (TEAEs) were reported by five subjects ( 13.2%, Table 21.1). None of the AEs were considered treatment-related. AEs were mild and one was moderate in intensity. None of the TEAEs were serious. All resolved by the end of the study. One TEAE (near-syncope) caused one subject to withdraw from the study. He withdrew from the group.

[0185] 6.2.2 Display of Adverse Events Adverse events are shown in Tables 21.2–21.3.

[0186] 6.2.3 Analysis of adverse events No statistical comparisons were made between groups.

[0187] 6.2.4 List of adverse events by subject A complete list of AEs is shown in Table 21.2.

[0188] 6.3 Deaths, other serious adverse events, and other significant adverse events 6.3.1 List of deaths, other serious adverse events, and other significant adverse events No deaths, serious adverse events (SAEs), or other significant AEs were reported.

[0189] 6.3.2 Description of Deaths, Other Serious Adverse Events, and Certain Other Significant Adverse Events Not applicable.

[0190] 6.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events Not applicable.

[0191] 6.4 Pregnancy No pregnancies occurred in the female cohort during the study period.

[0192] 6.5 Safety Conclusions None of the adverse events were considered to be related to the treatment, and therefore this study was Within the circumstances and based on the measurements taken, there is no evidence of safety concerns regarding the procedure.

[0193] 7 Discussion and overall conclusions 7.1 Discussion This study investigated the effects of fruit polyphenols combined with orange pulp (fiber source: pectin). of the extract on postprandial outcomes following a mixed carbohydrate (starch and sucrose) test meal The purpose of this study was to investigate the effect of BC polyphenols in combination with orange pulp. The extract significantly inhibited the rate of increase in plasma glucose during the early postprandial period (0-30 min). Pulp alone did not show a significant inhibitory effect on early postprandial glucose. The plasma glucose concentration at the end of the sampling period (T+150 min) was reduced.

[0194] BC+pulp significantly increased insulin secretion and GIP in the first 30 minutes after a meal compared to placebo. Pulp alone showed a significant inhibitory effect on GIP. However, there was no effect on insulin secretion. and had no inhibitory effect on C-peptide in the first 30 minutes after eating, but after eating fruit pulp Therefore, the C-peptide concentration in the BC+pulp treatment was higher in the 0-30 min period than in the pulp treatment alone. BC+pulp resulted in a significant reduction in thiamin monophosphate (THP) levels 150-180°C after ingestion of the test drink. When measured after 180 minutes, the effect of the placebo drink on attention (reactivity to a four-choice response task) was The study showed that the subjects had improved their ability to respond (measured as speed of response) and working memory (measured as reduction in the number of errors). intentionally increased.

[0195] The significant effect of BC+pulp on glucose absorption was observed in the intestinal glucose absorption rate. This was strongly supported by plasma GIP secretion, which is closely related to the

[0196] 7.2 Conclusion The primary and secondary outcomes were consistent with the mixed high-carbohydrate BC+ pulp drink alone. Supporting the conclusion that pulp alone altered the early acute metabolic response to food, The glucose-lowering effect of α-glucose was only evident at 150 min, the final sampling time point. Therefore, this was probably due to the addition (i.e., combination) of BC polyphenols. The improvements in attention and working memory parameters after BC + pulp represent novel and interesting findings. These findings warrant further study using a trial design in which these outcomes are primary endpoints. Further studies are warranted in populations at moderate risk for type 2 diabetes and cardiovascular disease. BC polyphenols and fruit fiber-rich diets on vascular metabolic risk factors and cognitive function The chronic effects of daily consumption of the drink should also be investigated.

[0197] 8 References

[0198] [Table 4]

[0199] 9 Tables, Charts and Graphs 9.1 Table

[0200] [Table 5]

[0201] [Table 6]

[0202] [Table 7]

[0203] [Table 8]

[0204] [Table 9]

[0205] [Table 10]

[0206] [Table 11]

[0207] [Table 12]

[0208] [Table 13]

[0209]

Table 14

[0210]

Table 15

[0211] Table 16

[0212] Table 17

[0213] Table 18

[0214]

Table 19

[0215] Table 20

[0216] Table 21

[0217] Table 22

[0218] Table 23

[0219] Table 24

[0220] Table 25

[0221] Table 26

[0222] Table 27

[0223] Table 28

[0224] Table 29

[0225] Table 30

[0226] Table 31

[0227] Table 32

[0228] Table 33

[0229] Table 34

[0230] Table 35

[0231] Table 36

[0232] Table 37

[0233] Table 38

[0234] Table 39

[0235] Table 40

[0236] Table 41

[0237]

Table 42-1

[0238]

Table 42-2

[0239] Table 43

[0240] [Table 44]

[0241] [Table 45]

[0242] [Table 46]

[0243] [Table 47]

[0244] Test 2 A study was conducted to evaluate the effect of polyphenols alone. Findings were related to the fiber content. Therefore, full details of this study are not included.

[0245] Postprandial elevation of blood glucose is a risk factor for the development of type 2 diabetes mellitus (T2DM) and other chronic diseases such as cardiovascular disease. It has been implicated in the disease (Blaak et al., 2012). Possible mechanisms include increased oxidative stress. , glycation of functional proteins, pancreatic beta cell dysfunction, and vascular damage (Cier Therefore, postprandial blood glucose control is important for metabolic disorders, including T2DM. It is important in the prevention and management of disease.

[0246] New evidence suggests acute fruit polyphenol supplementation may reduce postprandial blood glucose Dr. Wendy Hall's research group previously reported that 800 mg or A drink containing 1600mg of blackcurrant (BC) polyphenol extract, compared to a carbohydrate diet The effect of 16 on plasma glucose response was investigated (Castro-Acosta et al., 2016). 00mg BC extract drink (but not the 800mg drink) The mean incremental area above baseline (AOB; T0 to 30 min) of the sac was -0.34 mm Furthermore, this dose was found to suppress AOB T0-30 min, A At OB T0-120 min and T90 min, postprandial insulin, GIP and GLP- 1, respectively. No effect on postprandial blood glucose was observed at a dose of 800 mg of BC extract. However, the placebo drink contained tannins, which may have contributed to the reduction of the effects of the BC extract. The effect on postprandial blood glucose may have been masked.

[0247] The proposed primary mechanism of BC polyphenols on postprandial blood glucose is through the digestive enzymes in enterocytes. Primary activity and sodium-glucose cotransporter 1 (SGLT-1) / glucose transporter 2 The main effect is inhibition of the (GLUT-2) glucose transporter (Williamson, 2013). Other fruit polyphenols affect glucose homeostasis through different mechanisms. Citrus fruits, such as sweet oranges (SO), may have an adverse effect. Polyphenols exhibit only weak inhibition of digestive enzyme activity, but bind to starch molecules. This may mitigate carbohydrate digestion by reducing the amount of SO polyphenols present (Shen et al., 2012). The effects of phenol on postprandial blood glucose and related metabolites are still unknown. have different polyphenol profiles, with blackcurrants containing anthocyanins and proanthocyanins. It is rich in gins and flavanols, while SO is rich in flavanones, especially hesperidin (Neveu et al., 2010). Theoretically, the different structural and physiological properties of BC and SO extracts Combining fruit polyphenols with these compounds has a synergistic effect on reducing postprandial blood glucose levels. It can have a positive effect.

[0248] This research project focuses on the BC and SO polyphenol extracts and their combinations. to investigate the acute effects of on postprandial blood glucose after a mixed carbohydrate (starch and sucrose) meal. Compared with placebo (no fruit polyphenols), BC and SO polyphenols It was hypothesized that the extract alone would suppress postprandial blood glucose. Furthermore, the combination of BC and SO extracts had a greater effect on postprandial blood glucose than either BC or SO polyphenol extracts alone. To test these hypotheses, a low dose of BC extract ( Polyphenols 800mg), high dose BC extract (polyphenols 1600mg), low high-dose SO extract (800 mg), low-dose mixture of BC and SO extract (800 mg / 800mg) or a placebo (no polyphenols) The effects on plasma concentrations of glucose, insulinemia, and gut hormones were investigated. A controlled, crossover, single-diet, incomplete block design was used, with each subject receiving During the study, participants received a placebo and three of the four treatment drinks.

[0249] Many people of European descent are able to digest the sugar lactose, but this genetic trait The ability to digest lactose in adulthood is less common in other populations around the world. The symptom is known as lactase persistence, but this ability is naturally lost after weaning. In European populations, lactase phlorizin hydrolase (LPH) The activity of the enzyme is maintained into adulthood by a single nucleotide polymorphism (SNP) in the upstream region of the gene. A derived allele (C-13910) is thought to be the cause of LP in European adults. It is being done.

[0250] Importantly, the activity of LPH is essential for the absorption of dietary flavonoids, a key step in their absorption. It is also involved in the deglycosylation of LP (Nemeth, K., et al., 2003). It is rich in anthocyanin glycosides that are hydrolyzed by H. Anthocyanins are at least Partially inhibits digestive enzymes (amylase, disaccharidase) to lower postprandial blood sugar It is hypothesized that it inhibits the hydrolysis of anthocyanidins to their aglycone forms. A faster rate would be expected to be associated with a lesser degree of inhibition of glucose absorption.

[0251] This study compared the well-characterized LP allele with a placebo drink. Supplementation with a drink containing cereals and / or orange polyphenol extract followed by carbohydrate supplementation We investigated whether there was a relationship between the postprandial glycemic response to a soluble fiber diet and the soluble fiber diet.

[0252] Test Purpose Main purpose Effects of polyphenol-rich extracts of black currant and sweet orange on glucose absorption rate The primary endpoint was the iAUC of plasma glucose. 0-30min which is the baseline plasma glucose concentration from zero to the T30 minute sample time. It is defined as the change in area under the curve versus time.

[0253] Secondary Objectives including markers of glycemic response, insulin and gut hormone secretion, and appetite Effect of blackcurrant and sweet orange polyphenols on related parameters of glucose absorption To determine the effect of the ol-rich extract: 1. iAUC of plasma glucose concentration 0-120min . 2. Plasma insulin, C-peptide, NEFA, GIP, PYY and GLP-1 concentrations iAUC 0-30min and iAUC 0-120min . 3. Defined as the maximum change from baseline over the 120-minute sampling period. Plasma glucose, insulin, C-peptide, NEFA, GIP, PYY and GLP- 1 concentration increment C MAX (I C MAX ). 4. Plasma glucose, insulin, and C-peptide, defined as the time to maximum concentration T of NEFA, GIP, PYY and GLP-1 MAX . 5. Groups at each time point (T10, 20, 30, 45, 60, 75, 90 and 120 min) Blood glucose, insulin, C-peptide, NEFA, GIP, PYY and GLP-1 Plasma concentration. 6. Preference questions using VAS at T10 minutes, and at T-10, 10, 30, and 60 minutes Responses to mood and satiety questions at 90 and 120 minutes were analyzed using descriptive statistics. It is summarized as follows.

[0254] Clinical trial plan Description of overall study design and plan A randomized, placebo-controlled, double-blind, crossover study was conducted. Patients were randomized to one of four treatment arms in the design (Table 1). Over four separate visits All subjects received four drinks; placebo and three of the four test drinks. The low dose contained 800 mg of total polyphenols, and the high dose contained 1600 mg. The test drinks contained the following: a) low doses of BC polyphenols; b) high-dose BC polyphenols (L-BC), c) low-dose SO polyphenols (H-BC). lyphenol (L-SO), and d) containing low doses of both BC and SO polyphenols. The blended polyphenols (H-blend) contained a high dose of

[0255] [Table 48]

[0256] The minimum washout period was 7 days, and the effects of cyclical reproductive hormones in female subjects were considered. To minimize adverse effects, female subjects were only tested during the middle two weeks of their menstrual cycle (weeks 2 and 3). Attended a study visit.

[0257] Standardized dietary and exercise instructions were given before the visit (source data). After an overnight fast, participants had no caffeine intake since noon the previous day and were required to eat and drink at 8 a.m. to 1 p.m. at each study visit. The subject arrived between 10:00 and 19:00. The subject then had a forearm vein cannulated and two base Fasting blood samples were taken (T-10 and -5 min). After 1 minute, a high-carbohydrate meal (starch and sucrose) was offered (white bread and apricots). Plasma glucose analysis and serum insulin and plasma incretin and gastrointestinal For hormone analysis, at T10, 20, 30, 45, 60, 75, 90 and 120 min After the meal, blood samples were taken. The intervention ended when the T120 sample was taken. The tube was removed and the subject was offered a light breakfast and a hot drink.

[0258] treatment Treatment administered The LRS new product development team conducted a placebo and four active polyphenol-containing drinks. Five different treatments were provided, including a link. The drinks were 200ml each, and as much as possible Due to the differences in the natural sugars present in the BC and SO extracts, the flavor and color were matched. Different amounts of glucose, fructose and and sucrose were added.

[0259] [Table 49]

[0260] Discussion and Overall Conclusions In this study, BC and SO polyphenol extracts alone significantly improved postprandial blood glucose levels compared to placebo. and the combination of BC and SO extracts suppressed the inflammatory response more significantly than either extract alone. It was hypothesized that low doses of BC extract would have a significant effect on plasma glucose levels, primarily in the intestinal of plasma glucose in the first 30 minutes after a meal, a period determined by the rate of absorption However, unexpectedly, the high dose of BC extract significantly inhibited the rate of increase in this early postprandial The H containing 800 mg of both extracts showed no significant inhibitory effect on glucose levels. -The blend did not significantly alter glucose concentrations in the first 30 minutes. These results are puzzling, but it is unclear whether blackcurrant polyphenols are effective in reducing the risk of heart disease. This suppresses the glycemic response in the early postprandial period, confirming previous findings showing a reduction in the rate of intestinal glucose absorption. wear.

[0261] Regarding secondary outcomes, both the low-dose and high-dose extracts were significantly better than placebo. showed significant effects on insulin, C-peptide, and GIP in the first 30 minutes after eating. There is evidence that blackcurrant polyphenols alter the rate of glucose delivery into the circulation. The high dose blend extract showed a significant inhibitory effect only on GIP, and A reduction in the rate of intestinal glucose absorption was observed after a dose of 100 mg / kg, and a low dose of SO extract significantly reduced the rate of intestinal glucose absorption after a meal. Neither drink showed a significant inhibitory effect in the first 30 minutes after eating. It had no inhibitory effect on NEFA, PYY, or GLP-1. The results are consistent with previous studies showing that BC extract inhibits glucose absorption from 0 to 30 min ( Acosta Castro 2016). However, this study lacked a dose-response effect, and low doses Only the BC extract showed a significant effect.

[0262] The significant effect of lower doses of BC on glucose absorption was due to the increased rate of glucose absorption in the intestine. This was strongly supported by plasma GIP secretion, which was closely related to the degree of

[0263] Drinks containing blackcurrant polyphenol-rich extracts have been shown to reduce starch and sucrose It slows down the rate of glucose absorption after a meal containing hesperidin derived from sweet orange. The conclusion that gin has no perceptible effect is supported by the primary and secondary outcomes. It will be held. References

[0264] [Table 50]

[0265] Unless otherwise stated, all percentages herein are by weight. All pressures are absolute, not gauge.

[0266] Although preferred embodiments of the present invention have been described in detail herein, the present invention or any of the accompanying patents Those skilled in the art will recognize that modifications can be made thereto without departing from the scope of the claims. is understood by Illustrative Embodiments

[0267] The present invention encompasses the following list of exemplary embodiments. 1. At least 600 mg of polyphenols, and At least 1g of fiber A beverage composition comprising: 2. 700 to 2000 mg of polyphenols, preferably 800 to 1200 mg of polyphenols 2. The beverage composition of embodiment 1, comprising phenol. 3. Embodiment 1 or embodiment 2, comprising concentrated fruit extract as a source of polyphenols The beverage composition according to claim 1. 4. Embodiment 3, wherein the fruit extract is derived from one or more anthocyanin-rich fruits. The beverage composition according to claim 1. 5. Fruits rich in anthocyanins include blackcurrants, blackberries, blueberries, and pomegranates or a combination of two or more thereof. 6. Any of the preceding embodiments, wherein the polyphenols consist essentially of blackcurrant polyphenols. The beverage composition described above. 7.1. The preceding embodiment containing 25 to 3.5 g of fiber, preferably 1.5 to 2 g of fiber. The beverage composition according to any one of the above aspects. 8. The preceding embodiment, wherein substantially all of the fibers are natural fibers, preferably cellular pulp. The beverage composition according to any one of the above aspects. 9. The beverage composition of any of the preceding embodiments, comprising citrus fiber as a source of fiber. Finished product. 10. The beverage of any of the preceding embodiments, wherein the fiber consists essentially of citrus fiber. composition. 11. The beverage composition of any preceding embodiment, which is less than 100 Kcal. 12. Ready-to-drink, 100 to 1000 ml, preferably 100 to 750 ml, Preferably, the preceding solution has a volume of 150 to 500 ml, more preferably 200 to 300 ml. 10. The beverage composition of any of the embodiments. 13. The beverage composition of embodiment 12, wherein the beverage comprises less than 5g / 100ml of sugar. 14. Embodiments 1-1, provided as a concentrate for forming a beverage upon reconstitution with water. 2. A beverage composition according to any one of claims 1 to 11. 15. A method for improving cognitive function in a subject in need thereof, comprising administering to a subject a 10. The beverage composition of any one of the preceding embodiments. 16. The method of any one of embodiments 1 to 16 for use in methods for managing and / or treating type II diabetes 15. A beverage composition according to any one of 14. 17. A method for reducing postprandial blood glucose according to any one of embodiments 1 to 14. Beverage composition. 18. Promoting weight loss and / or body mass index in a subject in need thereof 15. A beverage composition according to any one of embodiments 1 to 14, for use in a method for improving 19. Any of embodiments 1 to 14 for use in a method for reducing the risk of cardiovascular disease. The beverage composition described above. 20. Prevent or reduce the risk of hypoglycemia due to blood glucose-induced insulin response 15. A beverage composition according to any one of embodiments 1 to 14 for use in a method. 21. Embodiments comprising combining a polyphenol-rich fruit extract with a natural fiber component 15. A method for forming a beverage composition according to any one of 1 to 14. 22. At least 600 mg of polyphenols, and At least 1g of fiber 1. A beverage composition ingested with or prior to carbohydrate supplementation, comprising: 23. A beverage composition according to any one of embodiments 1 to 13 for improving cognitive function. 24. Any of embodiments 1-13 for managing and / or treating type II diabetes The beverage composition according to claim 1. 25. A beverage composition according to any one of embodiments 1 to 13 for reducing postprandial blood glucose. 26. A method according to embodiment 1 for promoting weight loss and / or improving body mass index 14. A beverage composition according to any one of claims 1 to 13. 27. A beverage according to any one of embodiments 1 to 13 for reducing the risk of cardiovascular disease. composition. 28. Prevent or reduce the risk of hypoglycemia due to blood glucose-induced insulin response The beverage composition according to any one of embodiments 1 to 13. 29. A beverage according to any one of the preceding embodiments, wherein the serving size of the beverage composition is 50 ml to 1,000 ml. 10. A beverage composition according to any one of claims 9 to 9.

Claims

1. at least 600 mg of polyphenols, and At least 1g of fiber A beverage composition comprising:

2. 700 to 2000 mg of polyphenols, preferably 800 to 1200 mg of polyphenols The beverage composition of claim 1 , comprising alcohol.

3. 3. The method according to claim 1 or claim 2, comprising a concentrated fruit extract as a source of polyphenols. The beverage composition described.

4. 3. The fruit extract of claim 2, wherein the fruit extract is derived from one or more anthocyanin-rich fruits. The beverage composition according to claim 1.

5. The anthocyanin-rich fruits are blackcurrants, blackberries, blueberries, and zucchini. The beverage composition according to claim 4, wherein the beverage composition is selected from the group consisting of lactic acid bacteria, ...

6. 6. The method according to claim 1, wherein the polyphenols consist essentially of blackcurrant polyphenols. The beverage composition described above.

7. Any of claims 1 to 6, comprising 1.25 to 3.5 g of fibre, preferably 1.5 to 2 g of fibre. The beverage composition described in any one of the above.

8. Claims 1 to 7, wherein substantially all of the fibers are natural fibers, preferably cell pulp. The beverage composition according to any one of the preceding claims.

9. A beverage composition according to any one of claims 1 to 8, comprising citrus fiber as a source of said fiber. thing.

10. A beverage composition according to any one of claims 1 to 9, wherein the fiber consists essentially of citrus fiber. 。

11. It is ready to drink, and has a volume of 100 to 1000 ml, preferably 100 to 750 ml. 1 to 10, having a volume of 150 to 500 ml, preferably 200 to 300 ml.

10. A beverage composition according to any one of claims 1 to 9.

12. 12. The beverage composition of claim 11, wherein the beverage contains less than 5g / 100ml of sugar.

13. 11. The method of claim 1, provided as a concentrate for forming a beverage upon reconstitution with water. The beverage composition described in any one of the above.

14. Claim 1 for use in a method of treatment for improving cognitive function in a subject in need thereof.

14. A beverage composition according to any one of 1 to 13.

15. A method for the management and / or treatment of type II diabetes according to claims 1 to 13. The beverage composition described in any one of the above.

16. A beverage composition according to any one of claims 1 to 13 for use in a method for reducing postprandial blood glucose. Finished product.

17. Promoting weight loss and / or improving body mass index in a subject in need thereof A beverage composition according to any one of claims 1 to 13 for use in a therapeutic method for improving blood sugar levels.

18. A compound according to any one of claims 1 to 13 for use in a method for reducing the risk of cardiovascular disease. The beverage composition described above.

19. Methods for preventing or reducing the risk of hypoglycemic levels due to blood glucose-induced insulin response - Patents.com A beverage composition according to any one of claims 1 to 13 for use in

20. 1 to 1, comprising mixing a polyphenol-rich fruit extract with a natural fiber component.

3. A method of forming a beverage composition according to any one of claims 1 to 3.

21. A non-therapeutic method for improving cognitive function in a subject according to any one of claims 1 to 13. Use of the beverage composition described in claim 1.

22. Non-therapeutic methods for promoting weight loss and / or improving body mass index in a subject Use of the beverage composition according to any one of claims 1 to 13 in

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