Plant-based compositions and methods for management of chronic kidney disease

Abstract

A method for managing chronic kidney disease includes administering to an individual in need thereof a composition containing a plant based protein. The composition may have low glycemic index and may adhere to chronic kidney disease dietary restrictions. Additionally, the composition may have a PDCAAS score of 1. The method may also include managing chronic kidney disease at a pre-dialysis stage of the disease and managing chronic kidney disease in patients with diabetes.

Description

TITLEPLANT-BASED COMPOSITIONS AND METHODS FOR MANAGEMENT OF CHRONIC KIDNEY DISEASETECHNICAL FIELD

[0001] The present disclosure generally relates to compositions and methods for the management of chronic kidney disease. In preferred embodiments, the present disclosure relates to managing chronic kidney disease in a pre-dialysis stage or managing chronic kidney disease in individuals with diabetes by administering a composition comprising a plant-based protein.BACKGROUND

[0002] Chronic kidney disease occurs when the kidneys are unable to filter blood the way that they should. The main risk factors for chronic kidney disease are diabetes, high blood pressure, and heart disease. The inability for the kidneys to filter the blood leads to a condition called uremia, which is a build-up of toxic waste or urea in the blood.

[0003] End-stage chronic kidney disease usually results in the need for dialysis or the filtering of blood outside the body to remove the toxic waste. Before the disease progresses to the stage where dialysis is necessary, however, treatment for chronic kidney disease involves slowing the progression of the disease. Some management options include modifying diet or consuming nutritional supplements that follow the recommended diet, such as a low protein diet. The current solutions, however, are typically based on dairy proteins and do not provide options for patients choosing to follow a plant-based diet. Additionally, the nutritional supplements and diet recommendations may be geared toward chronic kidney disease, but may not provide benefits for underlying diseases associated with the chronic kidney disease, such as diabetes.SUMMARY

[0004] Plant-based proteins may have a protective action in the progression of chronic kidney disease. For example, plant-based proteins generate less uremic toxins than animal proteins and decrease the severity of uremia resulting in less stress on the kidneys. Lesser amounts of uremic toxins may slow the disease progression and affect patient survival.Additionally, plant-based proteins may protect chronic kidney disease patients from insulin resistance and inflammation.

[0005] The present disclosure provides a composition for managing chronic kidney disease including a plant-based protein in an amount between about 3 grams and about 12 grams per 100 ml or per 100 g of the composition. In some embodiments, the plant-based protein is a combination of pea protein and soy protein. The composition may also include a free amino acid giving the composition a Protein Digestibility Corrected Amino Acids Score score of 1. In particular embodiments, the composition for managing chronic kidney disease comprises a plant-based protein in combination with a carbohydrate with a low glycemic index such as isomaltulose so that the composition has a low glycemic index.

[0006] In some embodiments, the composition has a glycemic index below 70. In some embodiments, the composition further comprises a carbohydrate and a fiber, for example a carbohydrate with a low glycemic index such as isomaltulose. In some embodiments, the composition also includes an omega-3 fatty acid. Additionally, the composition may conform to chronic kidney disease diet restrictions.

[0007] In another embodiment, the present disclosure provides a method for management of chronic kidney disease, the method comprising administering to an individual in need thereof or at risk thereof a nutritional composition comprising a plant-based protein. In a preferred embodiment, the method is for management of chronic kidney disease in the predialysis stage of the disease. The individual in need thereof or at risk thereof may have chronic kidney disease and diabetes, so, in some embodiments, the method may also manage blood glucose level or aid in glycemic index.

[0008] Another aspect of the present disclosure is a composition for use in dietary management of chronic kidney disease, the composition comprising a plant-based protein in an amount between about 3 grams and about 12 grams per 100 ml or per 100 g of the composition. Yet another aspect of the present disclosure is a method of making an oral nutritional supplement. In some embodiments, the method comprises combining a plantbased protein, a fiber source, and at least one carbohydrate. In some embodiments, the method further comprises determining a ratio of the fiber source to the at least one carbohydrate so that the oral nutritional supplement has a medium or low glycemic index. In some embodiments, the at least one carbohydrate comprises at least one carbohydrate with a low glycemic index. The oral nutritional supplement may be a stable, liquid palatable product. In some embodiments, the oral nutritional supplement is a liquid with a viscosity of about 20 to about 180 centipoise.

[0009] An advantage of one or more embodiments provided by the present disclosure is to provide a plant-based composition for slowing the progression of chronic kidney disease.

[0010] Another advantage of one or more embodiments provided by the present disclosure is to manage chronic kidney disease at the pre-dialysis stage of the disease.

[0011] Still another advantage of the present disclosure is to provide a composition for the management of chronic kidney disease in patients with diabetes.

[0012] Yet another advantage of one or more embodiments is to provide a composition with a blend of carbohydrates and fiber to achieve a low glycemic index formulation.

[0013] Yet another advantage of the one or more embodiments is a single composition conforming to the chronic kidney disease dietary restrictions while also providing a plant based protein.

[0014] Additional features and advantages are described herein and will be apparent from the following Figures and Detailed Description.DETAILED DESCRIPTION

[0015] Definitions

[0016] Some definitions are provided hereafter. Nevertheless, definitions may be located in the “Embodiments” section below, and the above header “Definitions” does not mean that such disclosures in the “Embodiments” section are not definitions.

[0017] All percentages expressed herein are by weight of the total weight of the composition unless expressed otherwise. As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of numerals, for example the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number. All numerical ranges herein should be understood to include all integers, whole or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth. All ranges are inclusive of the endpoints of the range. For example, an amount between 1 and 10 includes both 1 and 10.

[0018] As used in this disclosure and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a protein” or “the protein” includes two or more proteins.

[0019] The words “comprise,” “comprises” and “comprising” are to be interpreted inclusively rather than exclusively. Likewise, the terms “include,” “including” and “or” should all be construed to be inclusive, unless such a construction is clearly prohibited from the context. Nevertheless, the compositions and methods disclosed herein may lack any element that is not specifically disclosed herein. Thus, a disclosure of an embodiment using the term “comprising” includes a disclosure of embodiments “consisting essentially of’ and “consisting of’ the components or steps identified.

[0020] The terms “at least one of’ and “and / or” used respectively in the context of “at least one of X and Y” and “X and / or Y” should be interpreted as “X without Y,” or “Y without X,” or “both X and Y.” Where used herein, the terms “example” and “such as,” particularly when followed by a listing of terms, are merely exemplary and illustrative and should not be deemed to be exclusive or comprehensive.

[0021] As used herein, “related to,” “associated with” and “linked with” mean occurring concurrently, preferably mean caused by the same underlying condition, more preferably mean that one of the identified conditions is at least indirectly caused by the other identified condition, and most preferably mean that one of the identified conditions is directly caused by the other identified condition.

[0022] The term “chronic kidney disease” refers to a gradual loss of kidney function. Kidneys filter wastes and excess fluids from the blood, which are then removed in the urine. Advanced chronic kidney disease can cause dangerous levels of fluid, electrolytes and wastes to build up in the body. Chronic kidney disease occurs when a disease or condition impairs kidney function, causing kidney damage to worsen over several months or years. Diabetes, genetic diseases such as polycystic kidney disease, and high blood pressure are three main risk factors.

[0023] The term “predialysis” shall refer to a stage of chronic kidney disease that has not progressed to the need for dialysis.

[0024] The term “diabetes” shall refer to a disease that results in high glucose levels in the bloodstream.

[0025] The terms “food”, “food supplement”, “food product” and “food composition” mean a product or composition that is intended for ingestion by an individual such as a human and provides at least one nutrient to the individual. The compositions of thepresent disclosure, including the many embodiments described herein, can comprise, consist of, or consist essentially of the elements disclosed herein, as well as any additional or optional ingredients, components, or elements described herein or otherwise useful in a diet supplement.

[0026] “Prevention” includes reduction of risk, incidence and / or severity of a condition or disorder. The terms “treatment,” “treat,” include both prophylactic or preventive treatment (that prevent and / or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or disease-modifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and / or halt progression of a diagnosed pathologic condition or disorder; and treatment of patients at risk of contracting a disease or suspected to have contracted a disease, as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition. The terms “treatment” and “treat” do not necessarily imply that a subject is treated until total recovery. The terms “treatment” and “treat” also refer to the maintenance and / or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition. The terms “treatment” and “treat” are also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measures. As non-limiting examples, a treatment can be performed by a patient, a caregiver, a doctor, a nurse, or another healthcare professional.

[0027] “Manage”, “management”, and “managing”, including in the context of “dietary management”, shall include measures that slow down, lessen symptoms of, and / or halt progression of a diagnosed pathologic condition or disorder. “Manage,” “management,” and “managing”, including in the context of “dietary management”, can also refer to regulating certain levels in the body within a normal biological range. For example, “managing blood glucose levels”, including “dietary management of blood glucose levels”, may refer to keeping blood sugar levels between 80 and 130 milligrams per deciliter (mg / dL) or 4.4 to 7.2 millimoles per liter (mmol / L) before meals, and less than 180 mg / dL (10.0 mmol / L) two hours after meals.

[0028] As used herein, a prophylactically or therapeutically “effective amount” is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or, more generally, reduces symptoms, manages progression of the disease, or provides a nutritional, physiological, or medical benefit to the individual.

[0029] “Plant-based” shall refer to products which typically comprise vegetables, fruits, tubers, legumes, cereals, seeds, oilseeds and / or nuts and are products not derived from animal products, such as bovine, poultry, and / or swine. In some embodiments, products derived from fish are considered plant-based.

[0030] “Glycemic index” or “GI” is a value from 0 to 100 assigned to foods based on how quickly and how high those foods cause increases in blood glucose levels. In some embodiments, a high glycemic index value is greater than or equal to 70, a medium glycemic index value is greater than 55 and less than 70, and a low glycemic index value is less than or equal to 55.

[0031] “Glycemic load” or “GL” shall refer to a classification of carbohydrates that takes into account the amount of carbohydrate in a portion of food together with how quickly it raises blood glucose levels. In some embodiments, a high glycemic load value is greater than or equal to 20, a medium glycemic load value is greater than 10 and less than 20, and a low glycemic load value is less than or equal to 10.

[0032] The expressions “fiber” or “fibers” or “dietary fiber” or “dietary fibers” within the context of the present invention indicate the indigestible portion, in small intestine, of food derived from plants which comprises two main components: Soluble fiber, which dissolves in water and insoluble fiber. Mixtures of fibers are comprised within the scope of the terms above mentioned. Soluble fiber is readily fermented in the colon into gases and physiologically active byproducts, and can be prebiotic and viscous. Insoluble fiber does not dissolve in water, is metabolically inert and provides bulking, or it can be prebiotic and metabolically ferment in the large intestine. Chemically, dietary fiber comprise non-starch polysaccharides such as arabinoxylans, cellulose, and many other plant components such as resistant starch, resistant dextrins, inulin, lignin, chitins, pectins, beta-glucans, and oligosaccharides. Non limiting examples of dietary fibers are: prebiotic fibers such as Fructooligosaccharides (FOS), inulin, galacto-oligosaccharides (GOS), fruit fiber, vegetable fiber, cereal fiber, resistant starch such as high amylose com starch, and vegetable gum, such as guar gum. As fibers are not digestible, they do not contain available carbohydrates, so they do not increase the GI or the GL. However, fiber does show Gl-lowering effects.

[0033] The expression “fat” or “fat source” or “lipid” or “lipid source” or “fats” in the context of the present invention indicates an edible solid or liquid fat or mixtures thereof. Not limiting categories of fats are those from animal, fish or vegetable origins. Non limiting examples of fats which could be used according to the present invention are: fish oil, cocoa butter, cocoa butter equivalents (CBE), cocoa butter substitutes (CBS), vegetable oils (for example rapeseed oil, palm oil, corn oil, soy oil, coconut oil and / or sunflower oil) and butter oils amongst others. In a preferred embodiment, the fat is plant-based.

[0034] The term “Protein Digestibility Corrected Amino Acids Score” or “PDCAAS” is the ratio of the limiting indigestible amino acid in test protein compared toreference protein corrected for faecal protein digestibility. In some embodiments, a PDCAAAS score of 1 indicates a complete protein.

[0035] As used herein, “chronic kidney disease dietary restrictions” shall refer to recommended amounts of nutrients that should be consumed by an individual to slow the progression of chronic kidney disease. Typically, this involves limiting the amount of protein, sodium, potassium, and / or phosphorous in the diet. On a per day basis, the National Kidney Foundation provides that potassium intake is less than 3000 mg; sodium is less than 2300 mg; and phosphorous is between 800-1000 mg. Additionally, the National Institute of Health recommends a low protein diet of 0.6-0.8 g / kg / day for the management of chronic kidney disease.

[0036] As used herein, the term “electrolytes” shall refer to minerals in your blood and other body fluids that carry an electric charge. The main electrolytes include sodium, potassium, and chloride along with magnesium, calcium, phosphorous, and bicarbonates.

[0037] The term “composition” may mean a food, beverage, dietary supplement, complete nutrition or oral nutritional supplement (ONS) or medical food composition, or mixture thereof.

[0038] The term “stable” shall refer to a composition without significant changes in moisture content, viscosity, homogeneity, appearance and / or odor for over three months of storage.

[0039] The nutritional composition of the present invention can be in solid form (e.g. powder) or in liquid form. The amount of the various ingredients can be expressed in g / 100 g of the composition on a dry weight basis when it is in a solid form, e.g. a powder, or as a concentration in g / 100 mL of the composition when it refers to a liquid form (this latter also encompasses liquid composition that may be obtained from a powder after reconstitution in a liquid such as water.)

[0040] Embodiments

[0041] In an aspect of the present disclosure, a composition for managing chronic kidney disease comprises a plant-based protein. In another aspect, a method of managing chronic kidney disease comprises administering to an individual in need thereof or at risk thereof a composition comprising a plant-based protein. In another aspect, a composition comprises a plant-based protein for use in dietary management of chronic kidney disease. In a preferred embodiment, the composition is an oral nutritional supplement.

[0042] The composition may be used to manage chronic kidney disease in an individual with chronic kidney disease. In a preferred embodiment, the composition may beused to manage chronic kidney disease at the pre-dialysis stage of the disease. In some embodiments, the individual may have chronic kidney disease and diabetes or chronic kidney disease associated with diabetes. In some embodiments, the composition slows the progression of the chronic kidney disease. In another aspect, a composition comprises a plantbased protein for use in dietary management of slowing the progression of chronic kidney disease. In some embodiments, the composition may manage blood glucose levels. In another aspect, a composition comprises a plant-based protein for use in dietary management of blood glucose levels.

[0043] The plant-based protein can comprise soy protein, pea protein, legume protein, nut protein, cereal protein, or combinations thereof. For example, the composition can comprise soy, peas, legumes, nuts, cereals, or combinations thereof, which provides at least a portion of the plant-based protein. The composition can comprise an amount of plant-based protein in accordance with chronic kidney disease dietary restrictions, for example between about 3 g and about 12 g of plant-based protein per 100 ml or 100 g of the composition. Specifically, the composition can comprise between about 3 g and about 6 g, between about 6 g and about 9 g, between about 9 g and about 12 g of plant-based protein per 100 ml or 100 g of the composition. In a preferred embodiment, the composition comprises between bout 3 g and about 6 g of plant-based protein per 100 ml or 100 g of the composition, specifically about 5 g of plant-based protein per 100 ml or 100 g of the composition. For example, methods can comprise administering a dose of the composition that comprises such amounts of plant-based protein.

[0044] In some embodiments, the composition comprises one or more free amino acids. Not all plant-based proteins contain all essential amino acids needed or not in the quantity needed to allow protein synthesis in the body. In some embodiments, inclusion of a free amino acid may complement the plant-based protein to give the composition a PDCAAS score of 1 indicating inclusion of complete protein. For example, the free amino acid may comprise lysine, methionine, threonine, tryptophan, cysteine, taurine, or combinations thereof. In some embodiments, the composition comprises one or more alpha-keto analogues. For example, the alpha-keto analogues may comprise one or more of isoleucine, leucine, phenylalanine, valine, and combinations thereof.

[0045] In some embodiments, the composition comprises electrolytes. The composition can comprise an amount of electrolytes in accordance with chronic kidney disease dietary restrictions. Non-limiting examples of electrolytes include sodium, potassium,phosphorus, calcium, and magnesium. In a preferred embodiment, the composition may be low in sodium, potassium, and / or phosphorous.

[0046] In a preferred embodiment, the composition has a low or medium glycemic index. For example, the composition may have a glycemic index of less than or equal to 55. The composition may also have a glycemic index between 55 and 70. In a preferred embodiment, the composition has a low glycemic load. For example, the composition may have a glycemic load of 10 or below.

[0047] In some embodiments, the composition has a high caloric density, for example, between about 1.5 kcal / ml and about 2.5 kcal / ml. Specifically, the composition may have a caloric density between about 1.5 kcal / ml and about 2 kcal / ml, or between about 2 kcal / ml and about 2.5 kcal / ml. In a preferred embodiment, the composition has a caloric density of about 2 kcal / ml.

[0048] In some embodiments, the composition further comprises omega-3 fatty acids. Omega-3 fatty acids have been shown to improve heart health and decrease uremic symptoms. Non-limiting examples of omega-3 fatty acids include fish oil (salmon, mackerel, tuna, herring, sardines, etc.), nuts, seeds, and plant oils (flaxseed, soybean, canola, etc.). In a preferred embodiment, the omega-3 fatty acids are plant-based.

[0049] In some embodiments, the composition further comprises carbohydrates. In some embodiments, the carbohydrate is selected from the group consisting of: resistant starches, Amylose, Sucrose, Lactose, Isomaltulose, Maltitol, Galactose, Fructose, Isomalt, Xilitol, maltodextrin, maltose and Polydextrose. In a preferred embodiment, the carbohydrate has a low glycemic index. For example, the carbohydrate may comprise isomaltulose.

[0050] In some embodiments, the carbohydrate has been modified to increase digestibility, for example by increasing chain length, cyclization, altering linkage profiles and / or increasing branching. Studies have shown that carbohydrates which are slowly digested result in a slow and prolonged provision of glucose into the blood over time, resulting in low glycemic response (See Delodder, F.; Rytz, A.; Foltzer, F.; Lamothe, L.; d’Urzo, C.; Feraille-Naze, L.; Mauger, J.; Morlet, J.; Piccardi, N.; Philippe, L.; Caijo, F.; Schmitt, J.; Colombo Mottaz, S. A Decentralized Study Setup Enables to Quantify the Effect of Polymerization and Linkage of a-Glucans on Post-Prandial Glucose Response. Nutrients 2022, 14, 1123. https: / / doi.org / 10.3390 / nul4051123, hereby incorporated by reference in its entirety).

[0051] In some embodiments, the composition comprises between about 15 grams and about 25 grams of available carbohydrates per 100 ml or 100 g of the composition.Specifically, the composition can comprise between about 15 g and about 17 g, between about 17 g and about 19 g, between about 19 g and about 22 g, between about 22 g and about 25 g of available carbohydrates per 100 ml or 100 g of the composition. In a preferred embodiment, the composition comprises between about 19 g and about 22 g of available carbohydrate per 100 ml or 100 mg of the composition.

[0052] In some embodiments, the composition further comprises fiber. When fiber is broken down in the body, the glycemic index of other foods in the body is lowered. Nonlimiting examples of suitable fibers include fructo-oligosaccharides (FOS), inulin, collagen, collagen peptides, vegetable gum, such as guar gum and mixtures thereof. In some embodiments, the composition comprises between about 1 g and about 3 g of fiber per 100 ml or 100 g of the composition. Specifically, the composition can comprise between about 1 g and about 2 g or between about 2 g and about 3 g of fiber per 100 ml or 100 g of the composition. In a preferred embodiment, the composition comprises about 2 g of fiber per 100 ml or 100 g of the composition.

[0053] In some embodiments, the composition comprises carbohydrates and fiber in an amount for the composition to have a low or medium glycemic index. For example, the ratio of carbohydrates to fiber may be between about 5: 1 and about 25:1. Specifically, the ratio of carbohydrates to fiber may be between about 5: 1 and 10: 1, between about 10: 1 and 15: 1, between about 15: 1 and about 20 : 1 , or between about 20 : 1 and about 25:1.

[0054] In one embodiment, the composition comprises an edible fat or mixtures thereof. For example the composition may comprise one or more vegetable oil (for example rapeseed oil, palm oil, com oil, soy oil, coconut oil and / or sunflower oil).

[0055] In some embodiments, the composition further comprises vitamins or additional minerals. Examples of minerals, vitamins and other nutrients optionally present in the composition of the invention include vitamin A, vitamin Bl, vitamin B2, vitamin B6, vitamin B12, vitamin E, vitamin K, vitamin C, vitamin D, folic acid, inositol, niacin, biotin, pantothenic acid, choline, calcium, iodine, iron, magnesium, copper, zinc, manganese, chlorine, selenium, chromium, molybdenum, taurine, and / or L-camitine.

[0056] The composition can be in any oral nutritional form, e.g., as a health drink, as a ready-made drink, optionally as a soft drink, including juices, coffee, tea, milk-shake, yogurt drink, smoothie or plant-based drink; in a food bar; a powder, such as in sachet form; or dispersed in foods of any sort, such as baked products, cereal bars, dairy bars, snack-foods, soups, breakfast cereals, muesli, candies, tabs, cookies, biscuits, crackers (such as ricecrackers), and dairy and plant-based products. In a preferred embodiment, the composition is plant-based.

[0057] The composition may be in the form of tablets, capsules, pastilles, a powder, or a liquid, for example. The composition may further contain protective hydrocolloids (such as gums, proteins, modified starches), binders, film forming agents, encapsulating agents / materials, wall / shell materials, matrix compounds, coatings, emulsifiers, surface active agents, solubilizing agents (oils, fats, waxes, lecithins or the like), adsorbents, carriers, fillers, co-compounds, dispersing agents, wetting agents, processing aids (solvents), flowing agents, taste masking agents, weighting agents, thickeners, stabilizers, jellifying agents and gel forming agents. The composition may also contain conventional additives and adjuvants, excipients and diluents, including, but not limited to, water, gelatin of any origin, vegetable gums, ligninsulfonate, talc, sugars, starch, gum arabic, vegetable oils, polyalkylene glycols, flavoring agents, preservatives, stabilizers, emulsifying agents, buffers, lubricants, colorants, wetting agents, fillers, and the like

[0058] The composition can be administered to the individual one or more times per day. In some embodiments, the composition can be administered to the individual at least two times per day, at least three times per day, at least four time per day, or at least five times per day. The composition can be administered to the individual at least two days per week, at least three days per week, all seven days of the week respecting serving size; for at least one week, at least one month, at least two months, at least three months, at least six months, or even longer. In some embodiments, the composition is administered to the individual consecutively for a number of days. In an embodiment, the composition can be administered to the individual daily for at least 30, 60 or 90 consecutive days.

[0059] In some embodiments, the serving size of the composition is an amount effective to manage chronic kidney disease, for example, about 100 ml, about 200 ml, or about 300 ml of the composition. In some embodiments, the serving size is between about 100 ml and about 300 ml, for example, between about 100 ml and about 200 ml or between about 200 ml and about 300 ml.

[0060] Another aspect of the present disclosure is a method of making a plant-based oral nutritional supplement. The method comprises combining a plant-based protein, a fiber source, and at least one carbohydrate to form an oral nutritional supplement with a high caloric density and conforming to chronic kidney disease dietary restrictions. The at least one carbohydrate may be a carbohydrate with a low glycemic index. The oral nutritional supplement is a stable, liquid palatable product. In some embodiments, the method of makingthe plant based oral nutritional supplement may comprise determining a ratio of fiber and carbohydrate so that the oral nutritional supplement has a low or medium glycemic index.

[0061] Examples

[0062] Example 1

[0063] The following non-limiting example is illustrative of compositions for slowing the progression of chronic kidney disease and / or managing blood glucose levels in embodiments provided by the present example.Table 1 : Three example compositions according to the present disclosure

[0064] Example 2

[0065] Predicted glycemic indexes (GI) and glycemic loads (GL) were calculated for the three compositions listed in Example 1. Calculations were conducted using a model that predicts GI and GL from macronutrient compositions, by quantifying both the impact of glycemic carbohydrates and the Gl-lowering effects of nutrients such as proteins, fats, and fibers. The model uses GI as a function of nutrients, not GI as a function of product like traditional methods. The model calculates GI using the following equation:

[0066] In the equation, Xiis the relative amount (%) of the ithmono / disaccharide (i= 1 . . . m); m is the number of glycemic carbohydrates; GL is the GI for that mono / disaccharide; a; is the correcting factor for the availability of glucose due to processing, such as in starch; n is the is the number of other non-glycemic nutrients, Xj is the relative amount of the jthnutrient; and bj characterizes the jthnutrients Gl-lowering power.

[0067] Glycemic load was predicted using the following equation:

[0068] Further details of the model are published in Rytz, A.; Adeline, D.; Le, K - A.; Tan, D.; Lamothe, L.; Roger, O.; Mace, K. Predicting Glycemic Index and Glycemic Load from Macronutrients to Accelerate Development of Foods and Beverages with Lower Glucose Responses. Nutrients 2019, 11, 1172. https: / / doi.org / 10.3390 / nul l051172, which is hereby incorporated by reference in its entirety.

[0069] The results of the model including the amounts of non-glycemic nutrients and glycemic carbohydrates for each composition are shown in Table 2.TABLE 2: Predicted GI and GL for compositions

[0070] GI for each composition is predicted to be slightly above the low glycemic index of 55 since the three products yield, respectively, a GI of 57, 60, and 59. The effect of increasing guar gum is estimated to have a very low impact. However, the model was developed on solid foods and although it has shown to work very accurately for liquids such as syrups, milks or cocoa-malt based beverages, the effect of thickeners in general, and particularly guar gums, on the glucose availability has not been properly implemented in the model. The predictions are therefore conservative, potentially slightly overestimating the GI and therefore the GL of the products.

Claims

CLAIMSClaim 1 : A composition for managing chronic kidney disease, the composition comprising a plant-based protein in an amount between about 3 grams and about 12 grams per 100 ml or per 100 g of the composition.Claim 2: The composition of claim 1, wherein the composition has a glycemic index below 70.Claim 3: The composition of claim 1 or claim 2, wherein the composition further comprises a carbohydrate and a fiber.Claim 4: The composition of claim 3, wherein the carbohydrate comprises at least one carbohydrate with a low glycemic index.Claim 5: The composition of claim 4, wherein the at least one carbohydrate with a low glycemic index comprises isomaltulose.Claim 6: The composition of any one of claims 1-5, wherein the composition further comprises a free amino acid, and the composition has a Protein Digestibility Corrected Amino Acids Score score of 1.Claim 7: The composition of any one of claims 1-6, wherein the composition further comprises an omega-3 fatty acid.Claim 8: The composition of any one of claims 1-7, wherein the composition conforms to chronic kidney disease diet restrictions.Claim 9: The composition of claim 8, wherein the composition is consumed as part of a diet providing less than 3000 mg / day potassium; less than 2300 mg / day sodium; and / or between 800-1000 mg / day phosphorous.Claim 10: The composition of any one of claims 1-9, wherein the plant based protein comprises pea protein and soy protein.Claim 11 : The composition of any one of claims 1-10, wherein the composition comprises(a) between about 15 g and about 25 g of carbohydrates per 100 ml or 100 mg of the composition and between about 1 g; and / or(b) about 3 g of fiber per 100 ml or 100 g of the composition.Claim 12: A method for management of chronic kidney disease, the method comprising administering to an individual in need thereof or at risk thereof a nutritional composition comprising a plant-based protein.Claim 13: The method of claim 12, wherein the individual in need thereof or at risk thereof comprises a human with(a) chronic kidney disease; or(b) chronic kidney disease and diabetes.Claim 14: The method of any one of claims 12 or claim 13, wherein the chronic kidney disease comprises chronic kidney disease in the pre-dialysis stage.Claim 15: The method of any one of claims 12-14, wherein the composition is administered to the individual in need thereof or at risk thereof in an amount effective to manage blood glucose levels and / or aid in glycemic index.Claim 16: The method of any one of claims 12-15, wherein the composition is an oral nutritional supplement.Claim 17: The method of any one of claims 12-16, wherein the composition is administered to the individual in need thereof in a single serving size of about 100 ml to about 200 ml.Claim 18: The method of any one of claims 12-17, wherein(a) a single serving of the composition is administered per day;(b) more than one serving of the composition is administered per day; or(c) up to five servings of the compositing is administered per day.Claim 19: The method of claim 18, wherein the composition is consumed as part of a diet providing less than 3000 mg / day potassium; less than 2300 mg / day sodium; and / or between 800-1000 mg / day phosphorous.Claim 20: The method of any one of claims 12-19, wherein the composition further comprises a carbohydrate and a fiber, and wherein the composition comprises between about 3 grams and about 12 grams of the plant-based protein per 100 ml or 100 g of the composition, between about 15 g and about 25 g of the carbohydrate per 100 ml or 100 g of the composition, and between about 1 g and about 3 g of the fiber per 100 ml or 100 g of the composition.Claim 21: The method of any one of claims 12-20, wherein the plant based protein comprises pea protein and soy protein.Claim 22: The method of any one of claims 12-21, wherein the composition has a glycemic index below 70.Claim 23: A composition for use in dietary management of chronic kidney disease, the composition comprising a plant-based protein in an amount between about 3 grams and about 12 grams per 100 ml or per 100 g of the composition.Claim 24: The composition of claim 23, wherein the composition has a glycemic index below 70.Claim 25: The composition of claim 23 or claim 24, wherein the composition further comprises a carbohydrate and a fiber.Claim 26: The composition of claim 25, wherein the carbohydrate comprises at least one carbohydrate with a low glycemic index.Claim 27: The composition of claim 26, wherein the at least one carbohydrate with a low glycemic index comprises isomaltulose.Claim 28: The composition of any of claims 23-27, wherein the composition furthercomprises a free amino acid, and the composition has a Protein Digestibility Corrected Amino Acids Score score of 1.Claim 29: The composition of any of claims 23-28, wherein the composition further comprises an omega-3 fatty acid.Claim 30: The composition of any one of claims 23-29, wherein the composition conforms to chronic kidney disease diet restrictions.Claim 31 : The composition of any one of claims 23-30, wherein the plant based protein comprises pea protein and soy protein.Claim 32: The composition of any one of claims 23-31, wherein the composition comprises(a) between about 15 g and about 25 g of carbohydrates per 100 ml or 100 mg of the composition and between about 1 g; and / or(b) about 3 g of fiber per 100 ml or 100 g of the composition.Claim 33: The composition of any one of claims 23-32, wherein the composition is to be administered to a human with(a) chronic kidney disease(b) chronic kidney disease and diabetes.Claim 34: The composition of any one of claims 23-33, wherein the chronic kidney disease comprises chronic kidney disease in the pre-dialysis stage.Claim 35: The composition of any one of claims 23-34, wherein the composition is administered in an amount effective to manage blood glucose levels and / or aid in glycemic index.Claim 36: The composition of claim 35, wherein the composition is to be administered to a human with chronic kidney disease and diabetes and the chronic kidney disease is chronic kidney disease in the pre-dialysis stage.Claim 37: A method of making an oral nutritional supplement, the method comprising combining a plant-based protein, a fiber source, and at least one carbohydrate.Claim 38: The method of claim 37, wherein the method comprises determining a ratio of the fiber source to the at least one carbohydrate so that the oral nutritional supplement has a medium or low glycemic index.Claim 39: The method of claim 37 or claim 38, wherein the at least one carbohydrate comprises at least one carbohydrate with a low glycemic index.Claim 40: The method of any one of claims 37-39, wherein the oral nutritional supplement is a stable, liquid palatable product.

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