Pediatric nutritional products with high real food content and plant-based proteins

Abstract

A nutritional composition comprising at least one material from fruit, the nutritional composition further comprising at least one plant protein, and the nutritional composition having a shear viscosity between 260 mPa·s and 460 mPa·s, when measured at 20°C and a shear rate of 100 s-1, and the nutritional composition has: a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and / or a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition.

Description

TITLE PEDIATRIC NUTRITIONAL PRODUCTS WITH HIGH REAL FOOD CONTENT AND PLANT-BASED PROTEINSBACKGROUND

[0001] Existing pediatric nutritional products attempting to deliver higher caloric levels (>1.2 kcal / mL) often contain allergens (such as milk protein) and do not contain levels of real foods above, e.g., 5.5% by weight. Existing pediatric nutritional products with high levels of real foods often have caloric density of around 0.7 kcal / mL and are not able to be used as sole sources of nutrition. Such products lacking a milk protein generally cannot be used as a complete nutritional product since the protein digestibility-corrected amino acid score (PDCAAS) is less than 1, which means the products do not provide 100% or more of the essential amino acids that a pediatric patient requires on a daily basis.

[0002] Many current squeezable pouches on the market containing pediatric nutritional products also have a low caloric density (at around 0.7 kcal / mL) and low protein levels (usually less than 3 g / lOOml) and fail to provide all essential amino acids.SUMMARY

[0003] The inventor recognized the need for a plant-based pediatric nutritional product as a sole source of nutrition to a subject such as a child. Accordingly, some embodiments of the present disclosure generally relate to a plant-based pediatric nutritional product having a shear viscosity between about 260 millipascal-second (mPa s) and about 460 mPa s, when measured at 20°C and a shear rate of 100 inverse second ( s'1) and when measured less than about 4 weeks from the date of manufacture of the nutritional product, free of all major allergens, with high levels (e.g., above 40% by weight) of real foods, with high caloric density (e.g., at least 1.2 kcal / mL), with at least one material of fruit providing fibers and / or carbohydrates, and with plant-based proteins providing a high protein level (e.g., at least 4% by weight) and providing all essential amino acids, wherein the nutritional product may comprises no more than 0.2% by weight of at least one free amino acid(s) added to supplement plant-based protein source, or wherein the nutritional product provides all essential amino acids without the addition of free amino acids to supplement plantbased product source.

[0004] The inventor unexpectedly developed the plant-based pediatric nutritional product disclosed herein, which is free of all major allergens and suitable as a sole source of nutrition to a subject (e.g., a child in need thereof). For example, a plant-based pediatric nutritional product can have a high real food content (e.g., 40% by weight to 60% by weight), a high protein level (e.g., at least 4.0% by weight), a high caloric density (e.g., at least 1.2 kcal / mL) and a shear viscosity between about 260 mPa s and about 460 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured less than about 4 weeks from the date of manufacture of the nutritional product. Such a shear viscosity range allows a subject in need thereof (e.g., a young child or child) to easily drink the plant-based pediatric nutritional product out of a container (e.g., a squeezable pouch) as a sole source of nutrition. A complete plant-based pediatric nutritional product can have a high real food content (e.g., 40% by weight to 60% by weight), a high protein level (e.g., at least 4.0% by weight), a high caloric density (e.g., at least 1.2 kcal / mL) provided in a daily serving of less than 1500 ml. It is understood that a daily serving may be divided into smaller parts to be provided throughout the day. In some embodiments, the daily serving is divided in up to 5 parts of about 150 ml each to meet the nutritional needs for a young child for an entire day, to 7 parts of about 150 ml each to meet the nutritional needs for a child for an entire day, or to 9 parts of about 150 ml each to meet the nutritional needs for an older child for an entire day.

[0005] In some embodiments, the present disclosure generally relates to a pediatric nutritional product comprising at least one material from fruit, further comprising at least one plant protein, and the pediatric nutritional product having a shear viscosity between about 260 mPa s and about 460 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured less than about 4 weeks from the date of manufacture of the nutritional product. The disclosed pediatric nutritional product may comprise no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than about 0.08% by weight, or no more than 0.07% by weight, of at least one free amino acids added to supplement a protein source. The disclosed pediatric nutritional product may be free of added free amino acids. In other words, in the disclosed pediatric nutritional products, no additional free amino acids may be added to supplement the protein source. The present disclosure further relates to methods of making and using such a pediatric nutritional product. The present disclosure relates to a pediatric nutritional product comprising the at least one material (e.g., fibers and carbohydrates) from fruits, further comprising at least one plant protein (e.g., pea protein and rice protein) providing all essentialamino acids, and the pediatric nutritional product has: a protein level between 3.0% by weight and 5.0% by weight of the nutritional product; and / or a caloric density between 1.2 kcal / ml and 2 kcal / ml of the nutritional product.DETAILED DESCRIPTION

[0006] Definitions

[0007] 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.

[0008] 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, including the endpoints. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 10, 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.

[0009] 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 component” or “the component” includes two or more components.

[0010] 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 as 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 identified.

[0011] The term “and / or” used in the context of “X and / or Y” should be interpreted as “X,” or “Y,” or “X and Y.” Similarly, “at least one of X or Y” should be interpreted as “X,” or“Y,” or “X and Y.” For example, “pea protein and / or rice protein” should be interpreted as “pea protein,” or “rice protein,” or “both pea protein and rice protein.”

[0012] 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. As used herein, a condition “associated with” or “linked with” another condition, means the conditions occur concurrently, preferably means that the conditions are caused by the same underlying condition, and most preferably means that one of the identified conditions is caused by the other identified condition.

[0013] The term “per serving,” as used herein, preferably refers to the amount of food in a sealed container such as a can or a pouch or a bottle or a powdered beverage sachet, or the amount per serving based on on-pack declaration. In some embodiments, per serving may refer to the volume of the food in a sealed container such as a can or a pouch or a bottle.

[0014] An “effective amount,” or “pharmaceutically effective amount,” as used herein, refers to an amount that prevents a deficiency, treats a disease or medical condition in an individual or, more generally, reduces symptoms, manages progression of the diseases or provides a nutritional, physiological, or medical benefit to the individual.

[0015] As used herein, the term “natural” means that the ingredient is not chemically synthesized and instead is derived from at least one natural source, for example a plant source, such as a fruit or a vegetable; a legume, a grain, a nut, or a seed; or a mixture thereof. The term “real food” means a food typically ingested by an individual in a normal daily diet when the food is in its natural or prepared state, as opposed to any reduced components of the food. In the context of “real food”, prepared state includes mechanical or physical manipulation of the at least one natural source such as pureeing, blending, grinding and / or chopping. It will be understood that prepared state in the context of “real food” does not include the chemical degradation of the natural source and / or isolation of individual components (such as protein, sugar or fat) from the natural source. An exemplary real food is a fruit puree, such as a banana puree, mango puree, blueberry puree, and combinations of any two or more thereof. In contrast to “real food”, the term “natural ingredient” means an ingredient derived from at least one natural source for example a protein source that is treated to obtain a natural ingredient, for example an isolated pea protein or isolated rice protein. It will be understood that highly refined ingredients such as sugar are not encompassed by the term “natural ingredient” or “real food”.

[0016] As used herein, the term “nutritional status” refers to the levels of nutrients in the body and the ability of those levels to maintain normal metabolic integrity and includes, for example, an analysis of growth for determination of growth failure, low Body Mass Index (BMI), and similar presentations. For children, weight and height for age may be compared with standard data for adequacy of nourished children. See, e.g. Vlaardingerbroek et al., Horm Res Paediatr (2024) 97: 11-21; Huda et al., Journal of Health and Rehabilitation Research (2024) 4 (doi.org / 10.61919 / jhrr.v4i2.1161); Papachristou et al. Journal of the Academy of Nutrition and Dietetics (2024) (doi.org / 10.1016 / j.jand.2024.05.019). The circumference of the head and the development of bones may also be measured. In one embodiment improved “nutritional status” is resolution of growth failure.

[0017] In some embodiments, the nutritional composition or product comprises one or more real food and / or natural ingredients. For example, the one or more real food and / or natural ingredients in the nutritional composition or product can comprise a natural protein source, such as at least one plant protein.

[0018] The term protein digestibility-corrected amino acid score (PDCAAS) is well understood and is a method of evaluating the quality of a protein in terms of the amino acids a source provides and the amino acid requirements of a human. See Dietary Protein Quality Evaluation in Human Nutrition, Report of an FAO Expert Consultation (ISN 0554-4725) available at WORLDWIDEWEB fao.org / ag / humannutrition / 35978-O2317b979a686a57aa45933O4ffcl7fO6.pdf A PDCAAS of 1 is the highest possible score and means that it provides all essential amino acids for humans. In the nutritional compositions herein described preferably have a PDCAAS of 1 as determined based substantially on the protein source alone. In some embodiments, the PDCAAS is determined on the contribution of the protein source including any free amino acid(s) that are added to supplement the at least one protein source, wherein the concentration of free amino acids(s) that are added may be no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than about 0.08% by weight, or no more than about 0.07% by weight. In some embodiments, the PDCAAS is determined substantially on the contribution of the protein source exclusive of any free amino acid(s) comprised in the nutritional composition or product. For example, in some embodiments comprising solely plant-based protein as the protein source, PDCAAS is determined substantially from the plant-based protein source. It is understood that “substantially” from theprotein source means that minor contribution to the PDCAAS determination is from the protein source but does not exclude the contribution from sources such as a fruit, vegetable, or honey, or other natural ingredient (e.g. rice flour). For the avoidance of doubt “substantially” from the protein source in the context of a PDCAAS determination means that additional added free amino acids are not included in the PDCAAS determination.

[0019] In some embodiments, the at least one plant protein comprises at least one of pea protein, or rice protein. The protein may be hydrolyzed or intact. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice protein. In some embodiments, the nutritional composition or product has a PDCAAS of 1, wherein the PDCAAS is determined on the basis of the at least one plant protein and at least one free amino acid(s) that may be added to supplement the at least one plant protein source, wherein the concentration of the at least one free amino acid(s) that may be added are no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than about 0.08% by weight, or no more than 0.07% by weight, of at least one free amino acids added to supplement a protein source and the at least one plant protein comprises a combination of pea protein and rice protein. In some embodiments, the at least one free amino acid(s) that may be added to supplement the protein source may be added at a concentration of no more than about 0.08% by weight or no more than about 0.07% by weight and the at least one plant protein comprises a combination of pea protein and rice protein. In some embodiments, the nutritional composition or product has a PDCAAS of 1, wherein the PDCAAS is determined substantially on the basis of the at least one plant protein, wherein the at least one plant protein comprises a combination of pea protein and rice protein with a PDCAAS of 1, wherein no free amino acids are added to supplement the PDCAAS. A “free amino acid” or related terms such as “free amino acids” as used herein refers to an amino acid that is not comprised in a peptide bond and is exogenous to (and is not derived from) a source of protein, real food, or natural ingredient in the nutritional composition or product. In some embodiments determining the PDCAAS of the nutritional composition or product, exogenous free amino acid(s) are not included in calculating the PDCAAS of the nutritional composition or product. In some embodiments determining the PDCAAS of the nutritional composition or product, the determination is based on the at least one protein and the at least one free amino acid(s) that may be added to the composition to supplement the protein source.

[0020] In embodiments in which at least one free amino acid(s) is added to supplement the protein source, the concentration of the at least one free amino acid(s) that are added may be no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than about 0.08% by weight, or no more than 0.07% by weight, of at least one free amino acids added to supplement a protein source.

[0021] In some embodiments, the at least one plant protein comprises a combination of intact and hydrolyzed pea protein and intact rice protein and the nutritional composition or product has a PDCAAS of 1, and has at least one free amino acid(s) wherein the concentration of the at least one free amino acids(s) that are added to supplement the protein source are no more than about 0.2% by weight and the PDCAAS is determined on the basis of the contribution of the protein and the added free amino acid(s). In some embodiments, the at least one plant protein comprises a combination of intact and hydrolyzed pea protein and intact and hydrolyzed rice protein where the nutritional composition or product has a PDCAAS of 1, and has at least one free amino acid(s) wherein the concentration of the at least one free amino acids(s) that are added to supplement the protein source are no more than about 0.2% by weight and the PDCAAS is determined on the basis of the contribution of the protein and the added free amino acid(s). In some embodiments, the at least one plant protein comprises an intact and / or hydrolyzed pea protein and intact and / or hydrolyzed rice protein where the nutritional composition or product has a PDCAAS of 1, and has at least one free amino acid(s) wherein the concentration of the free amino acids(s) that are added to supplement the protein source are no more than about 0.2% by weight and the PDCAAS is determined on the basis of the contribution of the protein and the added free amino acid(s).

[0022] In some embodiments, the at least one plant protein comprises a combination of intact and hydrolyzed pea protein and intact rice protein where the nutritional composition or product has a PDCAAS of 1, wherein no free amino acids are added to supplement the protein source in determining the PDCAAS. In some embodiments, the at least one plant protein comprises a combination of intact and hydrolyzed pea protein and intact and hydrolyzed rice protein where the nutritional composition or product has a PDCAAS of 1, wherein no free amino acids are added to supplement the protein source in determining the PDCAAS. In some embodiments, the at least one plant protein comprises an intact and / or hydrolyzed pea protein and intact and / or hydrolyzed rice protein where the nutritional composition or product has a PDCAASof 1, wherein no free amino acids are added to supplement the protein source in determining the PDCAAS.

[0023] In some embodiments, the one or more real food and / or natural ingredients in the nutritional composition or product can comprise one or more of carbohydrates, fats and / or fibers.

[0024] In some embodiments, the one or more real food and / or natural ingredients in the nutritional composition or product can comprise at least one material from fruit. In some embodiments, the one or more real food in the nutritional composition or product can comprise at least one material from fruit. In some embodiments, the one or more real food and / or natural ingredients in the nutritional composition or product can comprise at least one fruit in the form of a puree.

[0025] The term “nutritional composition or product,” as used herein, refers to any composition or product that can be used to provide nutrition to a subject.

[0026] In some embodiments, the nutritional composition or product may include a complete nutritional composition or product. For example, the complete nutritional composition or product (i.e., those which contain all the essential macro and micro nutrients) can be used as a sole source of nutrition for a patient or as an oral nutritional supplement (ONS). A patient can receive 100% of their nutritional requirements from such complete nutritional composition or product. An ONS composition may provide partial or complete nutritional composition or product or can contain mainly or exclusively the essential active ingredients of the claimed nutritional composition and can be consumed in addition to the regular nutrition of a patient.

[0027] In some embodiments, the nutritional composition or product is a pediatric nutritional composition or product.

[0028] In some embodiments, the pediatric population to nutritional composition or product may include patients from birth to 17 years, including age groups often called neonates, infants, children, and adolescents. For example, the neonates may include subjects from birth to age less than 1 month; infants may include subjects with age 1 month to less than 1 year; young children may include subject with ages 1 year to less than 4 years, children may include subjects with ages 4 to less than 7 years; and older children may include subjects with ages 7 to less than 15 years. In some embodiment, the pediatric population to nutritional or product may include patients from 1 year to 14 years of age. In some embodiments, the nutritional composition orproduct is suitable for a young child aged 1 year to less than 4 years, a child aged 4 years to less than 7, and / or an older child aged 7 years to less than 15 years.

[0029] In some embodiments, the pediatric nutritional composition or product may be used as a sole source of nutrition to a subject in need thereof. In some embodiments, the pediatric nutritional composition or product may be used as a sole source of nutrition to a subject in need thereof where the nutritional composition is provided in a serving of up to 150 ml up to 5 times per day for a young child, up to 150 ml up to 7 times per day for a child, or up to 150 ml up to 9 times per day for an older child.

[0030] The term “prevention” or “preventing,” as used herein, refers to reduction of risk, incidence, frequency and / or severity of a condition, disorder, or disease.

[0031] The term “treatment,” “treating,” “treat,” “attenuate,” or “alleviate,” as used herein, refers to both prophylactic or preventive treatment (that prevent and / or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or diseasemodifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and / or halt progression of a diagnosed pathologic condition or disorder, and include 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 term does not necessarily imply that a subject is treated until total recovery. These terms also refer to the maintenance and / or promotion of health in a subject not suffering from a disease but who may be susceptible to the development of an unhealthy condition. These terms are also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measure. A treatment can be patient- or doctor-related. In some embodiments, the condition comprises malnutrition or any health issue linked to malnutrition.

[0032] The relative terms “reducing” and “increasing,” as used herein, refer to effects of the nutritional compositions or products as disclosed herein as relative to the effect of another composition having a different protein level and / or caloric level but otherwise identically formulated.

[0033] The term “manage,” “managing,” and “management” as used herein, including in the context of “dietary management”, refers to the prevention or reduction in severity or frequency of one or more symptoms of a disease or condition, including ameliorating one or more existing symptoms of a disease or condition, preventing one or more existing symptoms of diseaseor condition, preventing one or more underlying causes of a disease or condition, ameliorating one or more underlying cause of a disease or condition, reducing the prevalence of one or more symptoms of a disease or condition, and / or reducing the occurrence of one or more symptoms of a disease or condition. It will be understood to include stabilizing a disease or condition and preventing progression of a disease or condition. In the context of the nutritional compositions or products disclosed herein it understood that such nutritional compositions or products can be used in the dietary management of a disease or condition. In some embodiments, the condition comprises malnutrition or any health issue linked to malnutrition.

[0034] The term “subject,” “individual,” or “patient,” as used herein, refers to a human, that could benefit from one or more of the nutritional products, compositions or methods as disclosed herein.

[0035] For example, the human may be a young child, a child, or an older child.

[0036] The term “shear viscosity” is well understood. In the context of the disclosed nutritional composition or product, it is understood to be a measure of the resistance to flow of the nutritional composition or product. The method of and / or instrument for measuring shear viscosity are not particularly limited. A preferred method includes measuring the viscosity is with the equivalent of an Anton Paar 302e Physica rheometer with cup and bob CC27 geometry at 20°C and a shear rate of 100 s'1.

[0037] The term “at least one material of fruit,” as used herein, refers to any material from a fruit. In some embodiments, the at least one material of fruit comprises any material from a fresh fruit. In some embodiments, the at least one material from fruit comprises a fruit puree comprising at least one fruit selected from the group consisting of mango, blueberry, apple, pear, orange, lemon, grapefruit, mandarin, nectarine, apricot, peach, plum, banana, pineapple, strawberry, raspberry, kiwifruit, passionfruit, watermelon, rockmelon, and honeydew melon.

[0038] In some embodiments, the at least one fruit is selected from the group consisting of mango, banana and blueberry, and combinations of two or more thereof.

[0039] The term “fruit puree,” as used herein, refers to a homogeneous product which has been prepared from whole or peeled fruit of good maturity, which has been pulped by a suitable physical process. See United States Department of Agriculture (USDA) authorized Commercial Item Description A-A-20252A dated Jun. 5, 2000 and the Codex General Standard For Fruit Juices and Nectars (CXS 247-2005). In some embodiments, the fruit puree may or may not have had aportion of the water physically removed. In some embodiments, the fruit puree may comprise one single kind of fruit. In some embodiments, the fruit puree may comprise two or more kinds of fruits.

[0040] The term “medium-chain triglycerides” or “MCTs,” as used herein, refers to triglycerides with two or three fatty acids having an aliphatic tail of 6-12 carbon atoms (i.e., medium-chain fatty acids (MCFAs)). Rich food sources for commercial extraction of MCTs may include palm kernel oil and coconut oil.

[0041] The term “nutrient,” or “nutrients,” as used herein, refers to any substance needed for health, growth, development and functioning of an organism. In some embodiments, the nutrients may comprise one or more of: macronutrients (e.g., protein, carbohydrates, fats) and their components (e.g., amino acids, sugars, starches, fatty acids, etc.), micronutrients (e.g., vitamins, minerals), other food components (fiber, cholesterol, bioactive phytochemicals, alcohol, etc.), and water contained in foods and beverages.

[0042] In some embodiments, the nutrients may comprise one or more substances of biotin, choline, folate, folic acid, inositol, L-carnitine, niacin, pantothenic acid, taurine, 0-carotene, or analogs or derivatives thereof.

[0043] Embodiments

[0044] NUTRITIONAL COMPOSITIONS OR PRODUCTS

[0045] An aspect of the present disclosure is a nutritional composition or product comprising at least one of the following nutrients and micronutrients: a source of protein, a source of lipid, a source of carbohydrate, and one or more vitamins and / or minerals.

[0046] In some embodiments, at least one of the source of protein, the source of lipid, the source of carbohydrate, the vitamins or the minerals is from real food. In some embodiments, two or more of the source of proteins, the source of lipid, the source of carbohydrate, the vitamins and / or the minerals are from real food.

[0047] In some embodiments, the nutritional composition or product comprises at least 40% by weight of real food, preferably at least 45% by weight of real food, more preferably at least 50% by weight of real food.

[0048] In some embodiments, the nutritional composition or product comprises at least one material from fruit, the nutritional composition or product further comprising at least one plant protein, and the nutritional composition or product having a shear viscosity, when measured at 20°C and a shear rate of 100 s’1, of between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, and even more preferably between about 315 mPa s and about 405 mPa s. In some embodiments, the shear viscosity of the nutritional composition or product is measured less than about 4 weeks from the date of manufacture, preferably less than about 3 weeks from the date of manufacture, and even more preferably between about 2 and about 3 weeks from the date of manufacture.

[0049] In some embodiments, shear viscosity may additionally be measured at about 6 months from the date of manufacture, where, when measured at 20°C and a shear rate of 100 s’1, the shear viscosity is greater than about 420 mPa s, greater than about 450 mPa s, or greater than about 465 mPa s.

[0050] In some embodiment, the nutritional composition or product has a pH less than 4.5, preferably the pH is less than 4.4. In some embodiments, the nutritional composition or product has a pH of about 3.5 to about 4.5, preferably pH of about 4.0 to about 4.3.

[0051] In some embodiments, the nutritional composition or product comprises at least one material from fruit and at least one plant protein, has a PDCAAS of 1, pH of 4.0 to 4.3, and is a complete nutritional composition.

[0052] In some embodiments, the nutritional composition or product comprises at least one material from fruit, at least one plant protein, and at least one free amino acid, has a PDCAAS of 1 , wherein the concentration of the free amino acids(s) that are added to supplement the protein source are no more than about 0.2% by weight, the PDCAAS is determined on the basis of the contribution of the protein and the added free amino acid(s), has a pH of 4.0 to 4.3, and has a shear viscosity of between about 315 mPa s and about 405 mPa s when measured at 20°C and a shear rate of 100 s’1and when measured between about 2 to 3 weeks after the date of manufacture. In some embodiments, the nutritional composition or product comprises at least one material fromfruit, at least one plant protein, and at least one free amino acid, has a PDCAAS of 1, wherein the concentration of the free amino acids(s) that are added to supplement the protein source are no more than about 0.2% by weight, the PDCAAS is determined on the basis of the contribution of the protein and the added free amino acid(s), has a pH of 4.0 to 4.3, and is a complete nutritional composition.

[0053] In some embodiments, the nutritional composition or product comprises at least one material from fruit and at least one plant protein, has a PDCAAS of 1 where the PDCAAS is determined without the contribution of a free amino acid, pH of 4.0 to 4.3, and has a shear viscosity of between about 315 mPa s and about 405 mPa s when measured at 20°C and a shear rate of 100 s'1and when measured between about 2 to 3 weeks after the date of manufacture. In some embodiments, the nutritional composition or product comprises at least one material from fruit and at least one plant protein, has a PDCAAS of 1, pH of 4.0 to 4.3, and is a complete nutritional composition. In some embodiments, the nutritional composition or product comprises at least one material from fruit and at least one plant protein, has a PDCAAS of 1 where the PDCAAS is determined without the contribution of a free amino acid, pH of 4.0 to 4.3, and has a shear viscosity of between about 315 mPa s and about 405 mPa s when measured at 20°C and a shear rate of 100 s'1and when measured between about 2 to 3 weeks after the date of manufacture.

[0054] The viscosity will be balanced to allow a pediatric patient, in one embodiment a young child aged 1 year to less than 4 years, to feed themselves from a squeezable container having a spout of fixed diameter. In one embodiment, the nutritional composition or product is comprised in a squeezable container with a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm. In this context, a nutritional composition or product with too high a viscosity will not flow sufficiently from a squeezable container with a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm, and consequently would inhibit a child from feeding themselves and having independence from their care giver. In contrast thereto, a nutritional composition or product with too low a viscosity will flow freely from a squeezable container with a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm, and may lead to chocking events and / or spillage depriving a child of at least a portion of the nutritional components of the nutritional composition or product. It has been surprisingly found that a nutritional composition or product being calorically dense can be achieved by the method described herein and to achieve a viscosity that allows for flowing from a squeezablecontainer with a spout of diameter from about 8 mm to 9 mm, preferably from about 8.5 mm to about 8.6 mm, such that a child is able to squeeze such a container with minimal force to liberate the nutritional composition or product and feed themselves and consume substantially all the nutritional composition or product with minimal leakage.

[0055] In some embodiments, the nutritional composition or product is plant-based. In some embodiments, the at least one plant protein is supplemented by at least one free amino acid(s) at a concentration of no more than about 0.2% by weight, wherein the at least one plant protein and added free amino acid(s) might provide all essential amino acids in the nutritional composition or product. In some embodiments, the at least one plant protein might provide all essential amino acids in the nutritional composition or product. The Food and Agricultural Organization / World Health Organization proposed a superior mean to identify protein quality, called “protein digestibility corrected amino acid score (PDCAAS),” which indicates how well a particular protein provides the required essential amino acids. In some embodiments, the at least one plant protein might substantially provide all essential amino acids in the nutritional composition or product with a PDCAAS of 1. In some embodiments, the at least one plant protein and the at least one free amino acid(s) that are added to supplement the protein source might substantially provide all essential amino acids in the nutritional composition or product with a PDCAAS of 1.

[0056] In some embodiments, at least one plant protein may be used as a sole source of protein in the nutritional composition or product.

[0057] In some embodiments, a preferred source of protein comprises plant protein because many plant proteins are hypo-allergenic. Plant proteins as intact proteins have advantages over the use of hydrolyzed protein or amino acids in free form because they superior in the nutritional composition with respect to taste and texture. Thus, plant proteins display an organoleptic superiority. Organoleptic superiority is especially important to ensure compliance with the dietary treatment of older children and teens which is rather low with compositions comprising hydrolyzed protein or amino acids in free form. A further advantage is the lower cost compared to nutritional compositions comprising hydrolyzed protein or amino acids in free form. A yet further advantage is that they appear to the consumer as a more normal diet.

[0058] Thus, in some embodiments, the source of protein can be at least one plant protein selected from the group consisting of potato protein, rice protein, legumes proteins (such as but not limited to pea, chickpea, beans), non-legumes proteins (vegetables), as well as rice,millet, quinoa, lupin, canola, tapioca or a combination thereof. The plant protein may be intact or hydrolyzed or a combination of intact and hydrolyzed. In some embodiments, the source of protein can be pea protein, rice protein, or a combination of pea protein and rice protein. In some embodiments, the source of protein is a combination of pea protein (intact and hydrolyzed) and rice protein (intact).

[0059] In some embodiments, potato protein can be a protein potato isolate (e.g., PROGO, Solamc, NL).

[0060] In some embodiments, rice protein can be a white or brown rice protein.

[0061] In some embodiments, the plant proteins can be the only source of protein in the nutritional composition or product or combined with other sources of protein, in particular, to supplement it with amino acids that are not present or underrepresented in plant protein to provide the required amounts of amino acids required by an animal or human. In some embodiments, one or more plant protein are supplemented with at least one free amino acid(s) at a concentration of no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than 0.08% by weight, or no more than 0.07% by weight, to provide the nutritional composition or product with a PDCAAS of 1 without the addition of non-plant proteins. In some embodiments, one or more plant protein substantially provides the nutritional composition or product with a PDCAAS of 1 without the addition of free amino acids and without the addition of non-plant proteins. Proteins can be intact, partially hydrolyzed, extensively hydrolyzed, cooked or modified in any other form to reduce allergenicity. In some embodiments, the protein is a combination of intact and hydrolyzed plant protein, wherein the plant protein is supplemented with at least one free amino acid(s) at a concentration of no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than 0.08% by weight, or no more than 0.07% by weight, to provide the nutritional composition or product with a PDCAAS of 1. In some embodiments, the protein is a combination of intact and hydrolyzed plant protein substantially providing the nutritional composition or product with a PDCAAS of 1 without the addition of free amino acids.

[0062] In some embodiments, the at least one plant protein comprises at least one of pea protein or rice protein. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice protein and the nutritional composition or product has a PDCAAS of 1. In some embodiments, the at least one plant protein comprises a combination ofpea protein and rice protein, wherein the protein are supplemented with at least one free amino acid(s) at a concentration of no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than 0.08% by weight, or no more than 0.07% by weight, and the nutritional composition or product has a PDCAAS of 1. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice protein and the nutritional composition or product has a PDCAAS of 1 where the PDCAAS is calculated without the contribution of any free amino acids in the nutritional composition or product.

[0063] In some embodiments, the at least one plant protein is selected from the group consisting of pea protein, rice protein and a combination thereof. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice portion and the nutritional composition or product has a PDCAAS of 1. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice protein, wherein the protein are supplemented with at least one free amino acid(s) at a concentration of no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than 0.08% by weight, or no more than 0.07% by weight, and the nutritional composition or product has a PDCAAS of 1. In some embodiments, the at least one plant protein comprises a combination of pea protein and rice protein and the nutritional composition or product has a PDCAAS of 1 where the PDCAAS is calculated without the contribution of any free amino acids in the nutritional composition or product.

[0064] In some embodiments, the ratio of amino acids from the protein source for Ile:Leu:Val is 0.5-0.7:0.9-l.l: 0.5-0.7. In preferred embodiments, the ratio of amino acids from the protein source for Ile:Leu:Val is about 0.6: 1:0.6. Exemplary nutritional compositions according to this embodiment are described in Examples 1 and 2.In some embodiments, the nutritional composition or product has two or more of the following ranges of ratios for amino acid profile relative to Leu.For the avoidance of doubt, this means that in some embodiments, the ratio of Ile:Leu:Val is in the range of 0.5-0.7:0.9-l.l:0.5-0.7.In a preferred embodiment, the nutritional composition or product has two or more of the following ratios for amino acid profile relative to Leu.For the avoidance of doubt, this means that in some preferred embodiments, the ratio of Ile:Leu is in the range of about 0.6: 1.0.

[0065] In some embodiments, the ratio of amino acids from the protein source for Ile:Leu:Val is 0.5-0.7:0.9-1.1: 0.6-0.8. In preferred embodiments, the ratio of amino acids from the protein source for Ile:Leu:Val is about 0.6: 1:0.7. Exemplary nutritional compositions according to this embodiment are described in Examples 4 and 5.In some embodiments, the nutritional composition or product has two or more of the following ranges of ratios for amino acid profile relative to Leu.For the avoidance of doubt, this means that in some embodiments, the ratio of Ile:Leu:Val is in the range of 0.5-0.7:0.9-l.1:0.6-0.8.In some embodiments, the nutritional composition or product has two or more of the following ratios for amino acid profile relative to Leu.For the avoidance of doubt, this means that in some preferred embodiments, the ratio of Ile:Leu is in the range of about 0.6: 1.0.

[0066] One advantage of the present nutritional composition or product over the existing pediatric nutritional products is that the present nutritional composition or product has a high protein level. For example, many existing nutritional products have low protein levels (e.g., usually less than about 3g per 100ml of the nutritional product).

[0067] In some embodiments, the nutritional composition or product has a higher protein level than the existing pediatric nutritional products. For example, the nutritional composition or product has a protein level of at least 3.5 g, preferably at least 4.0 g, more preferably at least 4.2 g, even more preferably at least 4.4 g, most preferably at least 4.5 g per 100 ml of the nutritional composition or product.

[0068] In some embodiments, the nutritional composition or product has a protein level of between 3.5 g and 6.0 g, preferably between 3.6 g and 5.4 g, per 100 ml of the nutritional composition or product.

[0069] The nutritional composition or product may comprise at least one free amino acid. In some embodiments, the nutritional composition or product comprises at least one free amino acid at a concentration of no more than about 0.2% by weight, no more than about 0.15% by weight, no more than about 0.1% by weight, no more than about 0.08% by weight, or no more than 0.07% by weight, wherein the free amino acid is added to supplement the protein source. In some embodiments, the nutritional composition or product comprises at least one free amino acid at a concentration of no more than about 0.08% by weight, wherein the free amino acid is added to supplement the protein source. In some embodiments, the nutritional composition or product comprises at least one free amino acid at a concentration of no more than about 0.07% by weight, wherein the free amino acid is added to supplement the protein source. In some embodiments, the at least one plant protein substantially provides a PDCAAS of 1 without the contribution of free amino acid(s).

[0070] In some embodiments, the at least one free amino acid comprises at least one of L-isoleucine, L-leucine, L-lysine, L-methionine, L-cysteine, L-cystine, L-phenylalanine, L- tyrosine, L-threonine, L-tryptophan, L-valine, L-arginine, L-histidine, L-alanine, L-aspartic acid, L-glutamic acid, L-glycine, L-proline, L-serine, L-asparagine, L-glutamine, L-citrulline, beta- Alanine, betaine (trimethylglycine), L-carnosine, dimethylglycine (DMG), hydroxyproline, hydroxylysine, or L-Theanine.

[0071] In some embodiments in which at least one free amino acid is added to the nutritional composition or product to supplement the protein source, the at least one free amino acid may comprise a combination of at least two free amino acids, at least three free amino acids, at least four free amino acids, or four or more free amino acids.

[0072] In some embodiments in which at least one free amino acid is added to the nutritional composition or product to supplement the protein source, the at least one free amino acid may comprise L-lysine and / or L-tryptophan. In some embodiments in which at least one free amino acid is added to the nutritional composition or product to supplement the protein source, the at least one free amino acid may consist of L-lysine and / or L-tryptophan.

[0073] In some embodiments, the nutritional composition or product comprises each of the at least one free amino acid in an amount of between 0.010 g and 0.800 g per 100 g of the nutritional composition or product, between 0.013 g and 0.790 g per 100 g of the nutritional composition or product, or between 0.04 to 0.2 g per 100 g of the nutritional composition orproduct. In some embodiments, the nutritional composition or product comprises each of the at least one free amino acid in an amount of between 0.04 to 0.2 g per 100 g of the nutritional composition or product, between 0.04 to 0.15 g per 100 g of the nutritional composition or product, between 0.04 to 0.1 g per 100 g of the nutritional composition or product, between 0.04 to 0.08 g per 100 g of the nutritional composition or product, or between 0.04 to 0.07 g per 100 g of the nutritional composition or product.

[0074] In some embodiments, the nutritional composition or product does not comprise any protein or free amino acid from an unnatural source. For example, all the proteins and amino acids in the nutritional composition or product may be from naturally existing sources.

[0075] In some preferred embodiments, the nutritional composition or product does not comprise any allergen.

[0076] One advantage of the present nutritional composition or product over the existing pediatric nutritional products is that the present nutritional composition or product is delivering high levels of real food and is free of all major allergens.

[0077] For example, the present nutritional composition or product may be free from any major allergen.

[0078] In some embodiments, the major allergen may comprise at least one of celery, cereals, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, peanuts, sesame, soybean, tree nuts (e.g., almond, brazil nut, cashew, hazelnut, macadamia nut, pecan nut, pistachio nut or walnut), sulphur dioxide, or sulphites.

[0079] In some embodiments, the major allergen is selected from the group consisting of milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and combinations thereof.

[0080] One advantage of the presently disclosed nutritional composition or product over the existing pediatric nutritional products is that the presently disclosed nutritional composition or product has a high caloric density. For example, many existing nutritional products have low caloric densities (e.g., usually around 0.7 kcal / ml).

[0081] In some embodiments, the nutritional composition or product has a higher caloric density than the existing pediatric nutritional products. For example, the nutritional composition or product has a caloric density of at least 1.1 kcal / ml, preferably at least 1.2 kcal / ml,more preferably at least 1.3 kcal / ml, even more preferably at least 1.4 kcal / ml of the nutritional composition or product.

[0082] In some embodiments, the nutritional composition or product has a caloric density between 1.0 kcal / ml and 2.0 kcal / ml, preferably between 1.0 kcal / ml and 1.8 kcal / ml, more preferably between 1.2 kcal / ml and 1.6 kcal / ml, even more preferably between 1.3 kcal / ml and 1.5 kcal / ml, further more preferably about 1.4 kcal / ml kcal / ml of the nutritional composition or product.

[0083] In some embodiments, the nutritional composition or product has the protein level between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and the caloric density between 1.4 kcal / ml and 1.5 kcal / ml of the nutritional composition.

[0084] In some embodiments, the at least one material from fruit comprises a fruit puree. In some embodiments, the fruit puree comprises at least one fruit selected from the group consisting of mango, blueberry, apple, pear, orange, grapefruit, mandarin, nectarine, apricot, peach, plum, banana, pineapple, strawberry, raspberry, kiwifruit, passionfruit, watermelon, rockmelon, and honeydew melon.

[0085] In some embodiments, the fruit puree comprises at least one fruit selected from the group consisting of mango, banana and blueberry. In some embodiments, the fruit puree comprises at a combination of two or more of mango, banana and blueberry.

[0086] In some embodiments, the fruit puree comprises at least two fruits selected from the group consisting of mango, blueberry, apple, pear, orange, grapefruit, mandarin, nectarine, apricot, peach, plum, banana, pineapple, strawberry, raspberry, kiwifruit, passionfruit, watermelon, rockmelon, and honeydew melon.

[0087] In some embodiments, the fruit puree comprises at least one first fruit and at least one second fruit. In some embodiments, the at least one first fruit comprises banana and the at least one second fruit comprises at least one fruit selected from the group consisting of mango and blueberry.

[0088] In some embodiments, the fruit puree comprises banana and blueberry. In some other embodiments, the fruit puree comprises banana and mango.

[0089] In some embodiments, the nutritional composition or product comprises at least 40% by weight of the fruit puree, preferably at least 45% by weight of the fruit puree, morepreferably at least 50% by weight of the fruit puree, even more preferably at least 51% by weight of the fruit puree, further more preferably at least 53% by weight of the fruit puree.

[0090] In some embodiments, the nutritional composition or product comprises between about 40% by weight and about 60% by weight, preferably between about 45% by weight and about 58% by weight, more preferably between about 50% by weight and about 55% by weight, even more preferably between about 52% by weight and about 55% by weight, further more preferably about 53% by weight of the fruit puree.

[0091] The nutritional composition or product may further comprise one or more of oils, vitamins, or minerals.

[0092] For example, the nutritional composition or product may further comprise one or more oils as a source of fats.

[0093] In some embodiments, vegetable oils are preferred in the practice of the present disclosure due to their readily availability, ease of formulation, and lower concentration of saturated fatty acids. Fat sources to be used may comprise corn oil, sunflower oil, safflower oil, canola oil, olive oil, high-oleic sunflower oil, high-oleic safflower oil, grape-oil, palm-derived oils, avocado oils, coconut oil or combinations thereof.

[0094] In some embodiments, the oils comprise one or more of olive oil, rapeseed oil, coconut oil, cottonseed oil, sunflower seed oil, safflower oil, grape oil, red palm oil, corn oil or combinations thereof.

[0095] In some embodiments, the nutritional composition or product comprises the oils between about 3.5% by weight and about 5.5% by weight, preferably between about 4% by weight and about 5.1% by weight, more preferably between about 4.4% by weight and about 5.0% by weight, even more preferably between about 4.7% by weight and about 4.9% by weight, and further more preferably about 4.8% by weight of the nutritional composition or product.

[0096] In some embodiments, the nutritional composition or product has a fat level between 2.0 g and 15.0 g, preferably between 3.0 g and 10.0 g, more preferably between 4.0 g and 8.0 g, even more preferably between 4.1 g and 7.3 g per 100 ml, and further more preferably about 5.7 g per 100 ml of the nutritional composition or product.

[0097] In some embodiments, the fats in the nutritional composition or product may include medium chain triglycerides (MCT, preferably 8 to 10 carbon atoms long, but could also include 12 carbons as well including the branched-chain isomers and even- and odd-numberedcarbons faty acids), long chain triglycerides (LCT, and their branched-chain isomers) or any combination of the two types. MCTs are beneficial because they are easily absorbed and metabolized in a metabolically-stressed patient especially because they serve as alternative fuel substrate and as bioactive and as a source for ketone bodies. Moreover, the use of MCTs may reduce the risk of nutrient malabsorption. LCT sources, such as canola oil, or any oil from the listed above, such as rapeseed oil, or corn oil are preferred because they can reduce immune suppression associated with certain types of fatty acids concentrated in the body.

[0098] In some embodiments, the fats in the nutritional composition or product may comprise at least one of saturated faty acids or unsaturated faty acids. In some embodiments, the unsaturated fatty acids may be either monounsaturated faty acids or polyunsaturated faty acids.

[0099] In some embodiments, the fats in the nutritional composition or product may comprise at least one of the saturated faty acids such as butyric acid (C4:0), caproic acid (C6:0), caprylic acid (C8:0), capric acid (C10:0), lauric acid (C12:0), myristic acid (C14:0), pentadecanoic acid (C15:0), palmitic acid (C16:0 in sn-2 position), margaric acid (C17:0), stearic acid (C18:0), arachidic acid (C20:0), behenic acid (C22:0) or lignoceric acid (C24:0).

[0100] In some embodiments, the fats in the nutritional composition or product may comprises myristic acid (C14:0), palmitic acid (C16:0), stearic acid (C18:0), arachidic acid (C20:0), and behenic acid (C22:0).

[0101] In some embodiments, the fats in the nutritional composition or product may comprise at least one of the monounsaturated fatty acids such as oleic acid (Cl 8: 1 n-9), gondoic acid (C20:l n-9), erucic acid (C22: l n-9), or nervonic acid (C24: l n-9).

[0102] In some embodiments, the fats in the nutritional composition or product may comprise at least one of the polyunsaturated faty acids such as linoleic acid (Cl 8:2 n-6), gamma linolenic acid (Cl 8:3 n-6), eicosadienoic acid (C20:2 n-6), dihomo gamma linolenic acid (C20:3 n-6), arachidonic acid (C20:4 n-6), docosadienoic acid (C22:2 n-6), docosapentaenoic acid (C22:5 n-6), alpha linolenic acid (C18:3 n-3), stearidonic acid (C18:4 n-3), eicosapentaenoic acid (C20:5 n-3), docosapentaenoic acid (C22:5 n-3), docosahexaenoic acid (C22:6 n-3) or eicosatrienoic acid (C20:3 n-3).

[0103] In some embodiments, the nutritional composition or product may comprise at least one of linoleic acid (C18:2 n-6) or alpha linolenic acid (C18:3 n-3). In some embodiments,the nutritional composition or product may comprise at least one of linoleic acid (Cl 8:2 n-6) and alpha linolenic acid (Cl 8:3 n-3).

[0104] The nutritional composition or product may further comprise one or more vitamins.

[0105] In some embodiments, the nutritional composition or product further comprises vitamins such as vitamin Bl (thiamin, thiamin pyrophosphate, TPP, thiamin triphosphate, TTP, thiamin hydrochloride, thiamin mononitrate), vitamin B2 (riboflavin, flavin mononucleotide, FMN, flavin adenine dinucleotide, FAD, lactoflavin, ovoflavin), vitamin B3 (niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotide, NAD, nicotinic acid mononucleotide, NicMN, pyridine-3 -carboxylic acid), vitamin B3-precursor tryptophan, vitamin B6 (pyridoxine, pyridoxal, pyridoxamine, pyridoxine hydrochloride), pantothenic acid (pantothenate, panthenol), folate (folic acid, folacin, pteroylglutamic acid), vitamin B12 (cobalamin, methylcobalamin, deoxyadenosylcobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin), biotin, vitamin C (ascorbic acid), vitamin A (retinol, retinyl acetate, retinyl palmitate, retinyl esters with other long-chain fatty acids, retinal, retinoic acid, retinol esters), vitamin D (calciferol, cholecalciferol, vitamin D3, 1,25,-dihydroxyvitamin D), vitamin E (a- tocopherol, a-tocopherol acetate, a-tocopherol succinate, a-tocopherol nicotinate, a-tocopherol), vitamin K (vitamin KI, phylloquinone, naphthoquinone, vitamin K2, menaquinone-7, vitamin K3, menaquinone-4, menadione, menaquinone-8, menaquinone-8H, menaquinone-9, menaquinone- 9H, menaquinone-10, menaquinone-11, menaquinone-12, menaquinone-13) and any combinations thereof.

[0106] The vitamins are included in amounts to meet the daily requirements as defined by the FDA.

[0107] In some embodiments, the nutritional composition or product further comprises at least one of vitamin A, vitamin D2, vitamin D3, vitamin E, vitamin KI, vitamin C, vitamin Bl, vitamin B2, vitamin B6, or vitamin Bl 2.

[0108] The nutritional composition or product may further comprise one or more minerals.

[0109] In some embodiments, the nutritional composition or product may comprise one or more minerals such as boron, calcium, calcium acetate, calcium gluconate, calcium chloride, calcium lactate, calcium phosphate, calcium sulfate, chloride, chromium, chromiumchloride, chromium picolonate, copper, copper sulfate, copper gluconate, cupric sulfate, fluoride, iron, carbonyl iron, ferric iron, ferrous fumarate, ferric orthophosphate, iron trituration, polysaccharide iron, iodide, iodine, magnesium, magnesium carbonate, magnesium hydroxide, magnesium oxide, magnesium stearate, magnesium sulfate, manganese, molybdenum, phosphorus, potassium, potassium phosphate, potassium iodide, potassium chloride, potassium acetate, selenium, sulfur, sodium, docusate sodium, sodium chloride, sodium selenate, sodium molybdate, zinc, zinc oxide, zinc sulfate and mixtures thereof. Non-limiting exemplary derivatives of mineral compounds include salts, alkaline salts, esters and chelates of any mineral compound cited above.

[0110] In some embodiments, the one or more minerals may comprise at least one of calcium, magnesium, phosphorus, sodium, potassium, chloride, manganese, iron, copper, zinc, selenium, iodine, chromium, molybdenum or fluoride. In some embodiments, the one or more minerals may comprise all of calcium, magnesium, phosphorus, sodium, potassium, chloride, manganese, iron, copper, zinc, selenium, iodine, chromium, molybdenum and fluoride.

[0111] The one or more minerals are included in amounts to meet the daily requirements as defined by the FDA.

[0112] The nutritional composition or product may further comprise at least one additional nutrient. In some embodiments, the at least one additional nutrient may comprise one or more substances of biotin, choline, folate, folic acid, inositol, L-carnitine, niacin, pantothenic acid, taurine, 0-carotene, or analogs or derivatives thereof.

[0113] In some embodiments, the nutritional composition or product may comprise L- carnitine in an amount of between about 1.0 mg and about 10.0 mg, preferably between about 2.0 mg and about 10.0 mg, more preferably between about 3.0 mg and about 10.0 mg, even more preferably between about 3.0 mg and about 8.0 mg, further more preferably between about 4.0 mg and about 7.5 mg, even further more preferably about 5.0 mg per 100 ml of the nutritional composition or product.

[0114] The nutritional composition or product may further comprise at least one additional ingredient comprising at least one of honey or lemon juice, preferably honey or lemon juice concentrate.

[0115] In some embodiments, the at least one additional ingredient comprises both honey and lemon juice, preferably honey and lemon juice concentrate.

[0116] In some embodiments, the nutritional composition or product comprises the honey in an amount of between about 2% by weight and about 6% by weight, preferably between about 3% by weight and about 5% by weight, more preferably about 4% by weight of the nutritional composition or product.

[0117] In some embodiments, the nutritional composition or product comprises the lemon juice, preferably lemon juice concentrate, in an amount of between about 0.5% by weight and about 1.7% by weight, preferably between about 0.9% by weight and about 1.2% by weight, more preferably about 1.0% by weight of the nutritional composition or product.

[0118] The nutritional composition or product may further comprise a solvent. In some embodiments, the solvent is water.

[0119] In some embodiments, the nutritional composition or product comprises at least 20% by weight of water, preferably at least 23% by weight of water, more preferably at least 25% by weight of water, further more preferably at least 29% by weight of water.

[0120] In some embodiments, the nutritional composition or product comprises between about 20% by weight and about 32% by weight, preferably between about 22% by weight and about 31% by weight, more preferably between about 24% by weight and about 30% by weight, even more preferably between about 27% by weight and about 30% by weight, further more preferably about 29% by weight of water.

[0121] In another aspect, the present disclosure relates to a food product comprising the nutritional composition as disclosed herein. In some embodiments, the food product comprises a container such as a pouch. The nutritional composition may be included in the container such as the pouch.

[0122] In some embodiments, the food product comprises a squeezable pouch containing the nutritional composition as disclosed herein.

[0123] In some embodiments, the squeezable pouch is a recyclable and eco-friendly pouch.

[0124] In some embodiments, the present disclosure relates to a unit dosage form of a nutritional composition comprising at least one material from fruit, the nutritional composition further comprising at least one plant protein, and the nutritional composition having a shear viscosity between about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rateof 100 s’l and when measured less than about 4 weeks after the date of manufacture of the nutritional composition, and the unit dosage form comprising: a protein level of between 3.6 g and 5.4g per 100 ml of nutritional composition; and / or a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml.

[0125] In some embodiments, the shear viscosity of the nutritional composition in the unit dosage form is, when measured at 20°C and a shear rate of 100 s’1, between between about 280 mPa s and about 440 mPa s, preferably between about 300 mPa s and about 420 mPa s, more preferably between about 315 mPa s and about 405 mPa s.

[0126] In some embodiments, the shear viscosity of the nutritional composition in the unit dosage form is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s’1, and when measured less than about 3 weeks from the date of manufacture of the nutritional composition.

[0127] In some embodiments, the shear viscosity of the nutritional composition in the unit dosage form is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s’1, and when measured between about 2 and about 3 weeks from the date of manufacture of the nutritional composition.

[0128] In some embodiments, the unit dosage form comprises a squeezable pouch comprising a spout of diameter from about 8 mm to 9 mm, preferably from about 8.5 mm to about 8.6 mm.

[0129] METHODS

[0130] Another aspect of the present disclosure is a method of manufacturing a nutritional composition, preferably a nutritional composition in a squeezable pouch.

[0131] In some embodiments, the method comprises providing each of the components of the nutritional composition as disclosed herein, each in an effective amount; and mixing the components in a sequence appreciated by the skilled artisan to form the food product comprisingthe nutritional composition as disclosed herein.

[0132] In some embodiments, the method further comprises mixing the components in a squeezable pouch to form the food product in the squeezable pouch.

[0133] Another aspect of the present disclosure relates to a method to prevent or mitigate a health issue linked to malnutrition (e.g., unplanned weight loss, a low body mass index (BMI) and vitamin and mineral deficiencies) in a subject in need thereof, by using the nutritional composition or product. In some embodiments, the method comprises administering to the subject in need thereof the nutritional composition or product as disclosed in the present disclosure.

[0134] In some embodiments, the method comprises administering to the subject a nutritional composition comprising at least one material from fruit, the nutritional composition further comprising at least one plant protein, and the nutritional composition having a shear viscosity about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s’1and when measured less than about 4 weeks from the date of manufacture of the nutritional composition, and the nutritional composition has: a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and / or a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition.

[0135] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s’1and when measured less than about 4 weeks from the date of manufacture of the nutritional composition.

[0136] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa- s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s’1, and when measured less than about 3 weeks from the date of manufacture of the nutritional composition.

[0137] In some embodiments, the shear viscosity of the nutritional composition isbetween about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s’ and when measured between about 2 and about 3 weeks from the date of manufacture of the nutritional composition.

[0138] In some embodiments, the protein level of the nutritional composition is between 3.5 g and 6.0 g, preferably between 3.6 g and 5.4 g, per 100 ml of the nutritional composition or product.

[0139] In some embodiments, the caloric density of the nutritional composition is preferably between 1.0 kcal / ml and 1.8 kcal / ml, even more preferably between 1.2 kcal / ml and 1.6 kcal / ml, further more between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition.

[0140] In some embodiments, the nutritional composition is a pediatric nutritional product.

[0141] In some embodiments, the subject is a human subject at an age of less than 15 years old or younger. For example, the human subject is any of a young child, a child, or an older child.

[0142] In some embodiments, the human subject is at an age between 1 year old and less than 15 years old.

[0143] In yet another aspect, the present disclosure relates to a method of treatment or prevention of a condition, disorder, or disease comprising administration of the nutritional composition or product as disclosed herein.

[0144] In some embodiments, the condition may be a health issue linked to malnutrition. In some embodiments, malnutrition is associated with a small appetite. In some embodiments malnutrition is associated with cystic fibrosis, congenital heart disease, or cancer. Malnutrition may be diagnosed, for example, as described in Cederholm T et al., Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40.

[0145] In yet another aspect, the present disclosure relates to a method of providing a sole source nutrition product to a subject in need thereof comprising administration of the nutritional composition or product as disclosed herein.

[0146] Another advantage of the present method and the present nutritional composition or product over the existing pediatric nutritional products is that the present methodprovides the nutritional composition or product as a sole source of nutrition to a subject in need thereof. An advantage of the present method is that the subject’s nutritional needs for an entire day can be met in a relatively small volume, increasing probability of compliance by the subject. In some embodiments, the total volume of nutritional product required to meet the daily nutritional need of a subject is less than 1500 ml.

[0147] In some embodiments, the nutritional product is suitable for a young child and the total volume of nutritional product required to meet the daily nutritional need of a subject is less than 1000 ml, preferably less than 850 ml, preferably less than 800 ml. In some embodiments, the nutritional product is suitable for a young child and the total volume of nutritional product required to meet the daily nutritional need of a subject is between about 725 ml and about 775 ml, preferably about 750 ml.

[0148] In some embodiments, the nutritional product is suitable for a child and the total volume of nutritional product required to meet the daily nutritional need of a subject is less than 1200 ml, preferably less than 1100 ml. In some embodiments, the nutritional product is suitable for a child and the total volume of nutritional product required to meet the daily nutritional need of a subject is between about 1025 ml and about 1075 ml, preferably about 1050 ml.

[0149] In some embodiments, the nutritional product is suitable for an older child and the total volume of nutritional product required to meet the daily nutritional need of a subject is less than 1500 ml, preferably less than 1400 ml. In some embodiments, the nutritional product is suitable for an older child and the total volume of nutritional product required to meet the daily nutritional need of a subject is between about 1325 ml and about 1375 ml, preferably about 1350 ml.

[0150] In some embodiments, the present method provides the plant-based pediatric nutritional product having a high real food content (e.g., 40 to 60%), a high protein level (e.g., 3.6g / 100 ml to 5.4 g / 100 ml), a high caloric density (e.g., 1.3 to 1.5 kcal / ml) and a shear viscosity between about 315 mPa s and about 405 mPa s when measured at 20°C and a shear rate of 100 s’1and when measured between about 2 and about 3 weeks from the date of manufacture of the nutritional product. Such a shear viscosity range allows a subject in need thereof (e.g., a child) to easily drink the plant-based pediatric nutritional product out of a container (e.g., a squeezable pouch) as a sole source of nutrition.

[0151] The nutritional composition or product may be administered by any methodappreciated by the skilled artisan. For example, the nutritional composition or product of the disclosure is preferably administered by oral administration.

[0152] In yet another aspect, the present disclosure relates to a use of a nutritional composition as disclosed herein for therapeutic and / or prophylactic treatment of a health issue linked to malnutrition in a subject in need thereof. The nutritional composition comprises at least one material from fruit, the nutritional composition further comprises at least one plant protein, and the nutritional composition having a shear viscosity between about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s'1and when measured between about 2 and about 3 weeks from the date of manufacture of the nutritional composition, and the nutritional composition has: a protein level of between 3.6 g and 5.4 g per 100 ml, preferably 5.0 g to 4.1g per 100 ml, of the nutritional composition; and / or a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml, preferably about 1.4 kcal / ml, of the nutritional composition.

[0153] In some embodiments, the shear viscosity of the nutritional composition is between between about 280 mPa s and about 440 mPa s, preferably between about 300 mPa s and about 420 mPa s, more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1.

[0154] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when the measured less than about 4 weeks from the date of manufacture of the nutritional composition.

[0155] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured less than about 3 week from the date of manufacture of the nutritional composition.

[0156] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.

[0157] In some embodiments, the protein level of the nutritional composition is between 4.1 g and 5.0g per 100 ml of the nutritional composition.

[0158] In some embodiments, the caloric density of the nutritional composition is between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition.

[0159] In some embodiments, the subject is a human subject at an age of 17 years old or younger.

[0160] In some embodiments, the human subject is at an age between 1 year old and 17 years old, preferably between 1 and less than 15 years of age. In some embodiments, the human subject is one or more of a young child with an age from 1 year to less than 4 years, a child with an agree from 4 years to less than 7 years, and an older child with an agree from 7 years to less than 15 years.

[0161] Another aspect of the present disclosure relates to a method of achieving at least one result selected from the group consisting of reducing incidence of malnutrition, mitigating or alleviating symptoms of malnutrition, mitigating delayed growth, reducing incidence of decreases in appetite, and increasing appetite in a subject in need thereof.

[0162] In some embodiments, the method comprises administering to the subject the nutritional composition or product as disclosed herein.

[0163] In some embodiments, the nutritional composition or product can lead to at least 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%,14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%,31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%,48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%,65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80% decrease on any of incidence of malnutrition, symptoms of malnutrition, or incidence of decreases in appetite in the subject as compared with the control subjects who were administered withanother composition having a different protein level and / or caloric level but otherwise identically formulated as the nutritional composition or product.

[0164] In some embodiments, the method may comprise administering to the subject a nutritional composition comprising at least one material from fruit, the nutritional composition further comprising at least one plant protein, and the nutritional composition having a shear viscosity between about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s'1and when measured less than about 4 weeks from the date of manufacture of the nutritional composition, and the nutritional composition has: a protein level of between 3.6 g and 5.4 g, preferably 4.1 g to 5.0 g per 100 ml, per 100 ml of the nutritional composition; and / or a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml, preferably about 1.4 kcal / ml, of the nutritional composition.

[0165] In some embodiments, the shear viscosity of the nutritional composition is between between about 280 mPa s and about 440 mPa s, preferably between about 300 mPa s and about 420 mPa s, more preferably between about 315 mPa s and about 405 mPa s, when measured at 20° C and a shear rate of 100 s'1and when measured less than about 4 weeks from the date of manufacture of the nutritional composition.

[0166] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when the measured less than about 4 weeks from the date of manufacture of the nutritional composition.

[0167] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about 440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured less than about 3 week from the date of manufacture of the nutritional composition.

[0168] In some embodiments, the shear viscosity of the nutritional composition is between about 260 mPa s and about 460 mPa s, preferably between about 280 mPa s and about440 mPa s, more preferably between about 300 mPa s and about 420 mPa s, even more preferably between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1and when measured between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.

[0169] In some embodiments, the nutritional composition or product of the present disclosure may have an acute effect that can be seen in less than one month. Additionally or alternatively, the nutritional composition or product of the present disclosure can have a long-term effect, and thus various embodiments comprise administration of the composition to the individual (e.g., orally) for a time period of at least one month; preferably at least two months, more preferably at least three, four, five or six months; and most preferably for at least one year. During the time period, the nutritional composition or product can be administered to the individual at least one day per week; preferably at least two days per week, more preferably at least three, four, five or six days per week; and most preferably seven days per week. The nutritional composition or product can be administered in a single dose per day or in multiple separate doses per day. In some embodiments, a single dose for the nutritional composition or product is between about 145 g / serving and about 165 g / serving, preferably between 155 g / serving and 165 g / serving, more preferably about 163 g / serving. In some embodiments, a single dose for the nutritional composition or product is between about 140 ml / serving and about 160 ml / serving, preferably between 145 ml / serving and 155 ml / serving, more preferably about 150 ml / serving.

[0170] In some embodiments, one day of complete nutrition of the nutritional composition or product suitable for a young child provides between 650 g and 980 g of the nutritional composition or product, preferably between 735 g and 898 g of the nutritional composition or product, more preferably between 775 g and 857 g of the nutritional composition or product. In some embodiments, one day of complete nutrition for the nutritional composition or product suitable for a young child provides between 600 ml and 900 ml of the nutritional composition or product, preferably between 675 ml and 825 ml of the nutritional composition or product, more preferably between 713 ml and 787 ml of the nutritional composition or product.

[0171] In some embodiments, one day of complete nutrition of the nutritional composition or product suitable for a child provides between 913 g and 1370 g of the nutritional composition or product, preferably between 1028 g and 1256 g of the nutritional composition or product, more preferably between 1085 g and 1199 g of the nutritional composition or product. Insome embodiments, one day of complete nutrition for the nutritional composition or product suitable for a child provides between 840 ml and 1260 ml of the nutritional composition or product, preferably between 945 ml and 1155 ml of the nutritional composition or product, more preferably between 998 ml and 1103 ml of the nutritional composition or product.

[0172] In some embodiments, one day of complete nutrition of the nutritional composition or product suitable for an older child provides between 1175 g and 1762 g of the nutritional composition or product, preferably between 1322 g and 1616 g of the nutritional composition or product, more preferably between 1396 g and 1542 g of the nutritional composition or product. In some embodiments, one day of complete nutrition for the nutritional composition or product suitable for an older child provides between 1080 ml and 1620 ml of the nutritional composition or product, preferably between 1215 ml and 1485 ml of the nutritional composition or product, more preferably between 1282 ml and 1418 ml of the nutritional composition or product.

[0173] All references cited herein are incorporated by reference in their entirety.

[0174] The invention includes the following embodiments:Embodiment 1.A nutritional composition comprising at least one real food, the nutritional composition further comprising at least one plant protein, the nutritional composing having(a) a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and(b) a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition; wherein the nutritional composition has(i) a protein digestibility-corrected amino acid score (PDCAAS) of 1,(ii) a pH of between 3.5 and 4.5, and(iii) does not comprise any milk proteins.Embodiment 2.A nutritional composition comprising at least one real food, the nutritional composition further comprising at least one plant protein, the nutritional composing having(a) a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and(b) a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition; wherein the nutritional composition(i) has a protein digestibility-corrected amino acid score (PDCAAS) of 1,(ii) has a pH of between 3.5 and 4.5,(iii) has a shear viscosity between about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s’1; and(iv) does not comprise any milk proteins.Embodiment 3.A nutritional composition comprising at least one real food, the nutritional composition further comprising at least one plant protein, the nutritional composing having(a) a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and(b) a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition; wherein the nutritional composition(i) has a protein digestibility-corrected amino acid score (PDCAAS) of 1,(ii) has a pH of between 3.5 and 4.5,(iii) has a shear viscosity between about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s’1;(iv) does not comprise any milk proteins; and(v) does not comprise a free amino acid.Embodiment 4.The nutritional composition of any one of Embodiments 1 to 3, wherein the PDCAAS is determined substantially on the basis of the plant protein.Embodiment 5.The nutritional composition of any one of Embodiments 1 to 4, wherein the PDCAAS is determined substantially on the basis of the plant protein wherein free amino acid(s) do not contribute to the PDCAAS determination.Embodiment 6.A nutritional composition comprising at least one real food, the nutritional composition further comprising at least one plant protein, the nutritional composing having(a) a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and(b) a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition; wherein the nutritional composition(i) has a protein digestibility-corrected amino acid score (PDCAAS) of 1,(ii) has a pH of between 3.5 and 4.5,(iii) has a shear viscosity between 1 about 260 mPa s and about 460 mPa s when measured at 20°C and a shear rate of 100 s’1;(iv) does not comprise any milk proteins; and(v) comprises no more than about 0.2% by weight of at least one free amino acid.Embodiment 7.The nutritional composition of Embodiment 6, wherein the nutritional composition comprises no more than about 0.15% by weight of at least one free amino acid.Embodiment 8.The nutritional composition of Embodiment 6 or Embodiment 7, wherein the nutritional composition comprises no more than about 0.1% by weight of at least one free amino acid.Embodiment 9.The nutritional composition of any one of Embodiments 6 to 8, wherein the nutritional composition comprises no more than about 0.08% by weight of at least one free amino acid.Embodiment 10.The nutritional composition of any one of Embodiments 6 to 9, wherein the nutritional composition comprises no more than about 0.07% by weight of at least one free amino acid.Embodiment 11.The nutritional composition of Embodiment 6, wherein the nutritional composition comprises at least one free amino acid in an amount of between about 0.04 to 0.2 g per 100 g of the nutritional composition or product.Embodiment 12.The nutritional composition of Embodiment 6 or Embodiment 11, wherein the nutritional composition comprises at least one free amino acid in an amount of between about 0.04 to 0.15 g per 100 g of the nutritional composition or product.Embodiment 13.The nutritional composition of any one of Embodiments 6, 11, and 12wherein the nutritional composition comprises at least one free amino acid in an amount of between about 0.04 to 0.1 g per 100 g of the nutritional composition or product.Embodiment 14.The nutritional composition of any one of Embodiments 6 and 11 to 13, wherein the nutritional composition comprises at least one free amino acid in an amount of between about 0.04 to 0.08 g per 100 g of the nutritional composition or product.Embodiment 15.The nutritional composition of any one of Embodiments 6 and 11 to 14, wherein the nutritional composition comprises at least one free amino acid in an amount of between about 0.04 to 0.07 g per 100 g of the nutritional composition or product.Embodiment 16.The nutritional composition of any one of Embodiments 6 to 15, wherein the at least one free amino acid comprises or consists of L-Lysine and / or L-Tryptophan.Embodiment 17.The nutritional composition of any one of Embodiments 6 to 16, wherein the PDCAAS is determined on the basis of the protein and the free amino acid.Embodiment 18.The nutritional composition of any one of Embodiments 1 to 17, wherein the nutritional composition comprises at least 40% by weight real food or between 40% to 60% by weight real food.Embodiment 19.The nutritional composition of Embodiment 18, comprising at least(a) 45% by weight real food;(b) 50% by weight real food; or(c) 53% by weight real food.Embodiment 20.The nutritional composition of any one of Embodiments 1 to 19, wherein in the at least one real food is at least one fruit.Embodiment 21.The nutritional composition of Embodiment 20, wherein the real food consists of one or more fruits, preferably wherein the one or more fruits are in the form of a fruit puree.Embodiment 22.The nutritional composition of Embodiment 21, wherein the one or more fruits are a combination of banana and blueberry or banana and mango.Embodiment 23.The nutritional composition of any one of Embodiments 1 to 22, having a protein level of about 4.5g per 100 ml of the nutritional composition and a caloric density of about 1.4 kcal / ml of the nutritional composition.Embodiment 24.The nutritional composition of any one of Embodiments 1 to 23, wherein the nutritional composition is nutritionally complete, preferably wherein one day’s nutritional requirement are provided in less than about 1,500 ml of the nutritional composition.Embodiment 25.The nutritional composition of Embodiment 24, wherein a single dose of the nutritional composition is(a) between 155 g / serving and 165 g / serving; or(b) about 163 g / serving.Embodiment 26.The nutritional composition of Embodiment 24, wherein a single dose of the nutritional composition is(a) 145 ml / serving and 155 ml / serving; or(b) about 150 ml / serving.Embodiment 27.The nutritional composition of any one of Embodiments 24 to 26, which provides one day’s nutritional requirement for a subject, wherein the subject is young child, child or an older child.Embodiment 28.The nutritional composition of Embodiment 27, wherein(a) the subject is a young child and wherein the nutritional composition provides one day’s nutritional requirement in up to 5 servings;(b) the subject is a child and wherein the nutritional composition provides one day’s nutritional requirement in up to 7 servings; and / or(c) the subject is an older child and wherein the nutritional composition provides one day’s nutritional requirement in up to 9 servings.Embodiment 29.The nutritional composition of Embodiment 27 or Embodiment 28, wherein(a) the subject is a young child and the nutritional composition provides one day’s nutritional requirement in about 713 ml to about 787 ml;(b) the subject is a child and the nutritional composition provides one day’s nutritional requirement in about 1102 ml to about 998 ml; or(c) the subject is an older child and the nutritional composition provides one day’s nutritional requirement in about 1282 ml to about 1396 ml; of the nutritional composition.Embodiment 30.The nutritional composition of any one of Embodiments 1 to 29, wherein the at least one plant protein is pea protein, rice protein or a combination thereof.Embodiment 31.The nutritional composition of any one of Embodiments 1 to 29, wherein the at least one plant protein is a combination of pea protein and rice protein.Embodiment 32.The nutritional composition of Embodiment 31 , wherein the pea protein is a combination of intact and hydrolyzed protein and the rice protein is intact protein.Embodiment 33.The nutritional composition of any one of Embodiments 1 to 32, wherein the nutritional composition is packaged in a squeezable container.Embodiment 34.The nutritional composition of Embodiment 33, wherein the squeezable container has a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm.Embodiment 35.A squeezable container having a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm, comprising a nutritional composition as defined in any one of Embodiments 1 to 28.Embodiment 36.The nutritional composition of any one of Embodiments 1 to 34 for use in the treatment or prevention of malnutrition.Embodiment 37.The nutritional composition of any one of Embodiments 1 to 34 for use in the dietary management of malnutrition.Embodiment 38.The nutritional composition for the use of Embodiment 36 or Embodiment 37, wherein the composition is for administration to a young child, child and / or an older child.Embodiment 39.The nutritional composition of any one of Embodiments 1 to 34 for use in inducing weight gain in a young child or child having malnutrition or at risk of developing malnutrition.Embodiment 40.The nutritional composition of any one of Embodiments 1 to 34 for use in preventing malnutrition in a young child or child having decreased appetite.Embodiment 41.The nutritional composition of any one of Embodiments 1 to 34 for use in improving the nutritional status of a young child or child having decreased appetite.Embodiment 42.A method of(a) treating or preventing malnutrition;(b) dietary management of malnutrition;(c) inducing weight gain in a young child, child and / or an older child having malnutrition or at risk of developing malnutrition;(d) inducing weight gain in a young child, child and / or an older child having malnutrition or at risk of developing malnutrition;(e) preventing malnutrition in a young child, child and / or an older child having decreased appetite; or(f) improving the nutritional status of a young child, child and / or an older child having decreased appetite; comprising administering to a young child or child a composition of any one of Embodiments 1 to 34.Embodiment 43.A method of Embodiment 42, comprising providing the young child, child and / or older child the squeezable package of Embodiment 35.Embodiment 44.Use of a nutritional composition according to any one of Embodiments 1 to 32 for the manufacture of a product for(a) treating or preventing malnutrition;(b) dietary management of malnutrition;(c) inducing weight gain in a young child, child and / or an older child having malnutrition or at risk of developing malnutrition;(d) inducing weight gain in a young child, child and / or an older child having malnutrition or at risk of developing malnutrition;(e) preventing malnutrition in a young child, child and / or an older child having decreased appetite; or(f) improving the nutritional status of a young child, child and / or an older child having decreased appetite.Embodiment 45.The use of Embodiment 44, wherein the product is in the form of a squeezable package having a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm.Embodiment 46.The nutritional composition of any one of Embodiments 1 to 32, the squeezable container of Embodiment 35, the nutritional composition for the use of any one of Embodiments 36 to 41, the method of Embodiment 42 or Embodiment 43, or the use of Embodiment 44 or Embodiment 45, wherein the nutritional composition does not comprise any allergen.Embodiment 47.The nutritional composition of Embodiment 46, wherein the allergen is selected from the group consisting of milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and combinations thereof.Embodiment 48.The nutritional composition, the squeezable container, use, or method of any one of the preceding Embodiments, wherein the amino acid profile of the nutritional composition has at least two or more of the following ranges of ratios of amino acids:Embodiment 49.The nutritional composition, the squeezable container, use, or method of any one of the preceding Embodiments, wherein the amino acid profile of the nutritional composition has at least two or more of the following ratios of amino acids:Embodiment 50.The nutritional composition, the squeezable container, use, or method of Embodiment 49, wherein the amino acid profile of the nutritional composition has the following ratios of amino acids:Embodiment 51.The nutritional composition of any one of Embodiments 1 to 32, the squeezable container of Embodiment 35, the nutritional composition for the use of any one of Embodiments 36 to 41, the method of Embodiment 42 or Embodiment 43, or the use of Embodiment 44 or Embodiment 45,wherein the amino acid profile of the nutritional composition has at least two or more of the following ranges of ratios of amino acids:Embodiment 52.The nutritional composition of any one of Embodiments 1 to 32, the squeezable container of Embodiment 35, the nutritional composition for the use of any one of Embodiments 36 to 41, the method of Embodiment 42 or Embodiment 43, or the use of Embodiment 44 or Embodiment 45, wherein the amino acid profile of the nutritional composition has at least two or more of the following ratios of amino acidsEmbodiment 53.The nutritional composition of any one of Embodiments 1 to 32, the squeezable container of Embodiment 35, the nutritional composition for the use of any one of Embodiments 36 to 41, the method of Embodiment 42 or Embodiment 43, or the use of Embodiment 44 or Embodiment 45, wherein the amino acid profile of the nutritional composition has the following ratios of amino acidsEmbodiment 54.The nutritional composition, the squeezable container, use, or method of any one of the preceding Embodiments, wherein the nutritional composition has a shear viscosity of between(a) about 260 mPa s and about 460 mPa s;(b) about 280 mPa s and about 440 mPa s;(c) about 300 mPa s and about 420 mPa s; or(d) about 315 mPa • s and about 405 mPa • s, when measured at 20°C and a shear rate of 100 s'1.Embodiment 55.The nutritional composition, the squeezable container, use, or method of any one of the preceding Embodiments, wherein the nutritional composition has a shear viscosity of between about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1.Embodiment 56.The nutritional composition, the squeezable container, use, or method of Embodiment 54 or Embodiment 55, wherein the nutritional composition has a shear viscosity is measured(a) less than about 4 weeks from the date of manufacture of the nutritional composition;(b) less than about 3 weeks from the date of manufacture of the nutritional composition; or(c) between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.Embodiment 57.The nutritional composition, the squeezable container, use, or method of Embodiment 54 or Embodiment 55, wherein the nutritional composition has a shear viscosity is measured between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.Embodiment 58.The nutritional composition, the squeezable container, use, or method of any one of Embodiments 54 to 57, wherein the shear viscosity is additional measured about 6 months from the date ofmanufacture of the nutritional product and wherein the shear viscosity is greater than about 420 mPa s, greater than about 450 mPa s, or greater than about 465 mPa s, when measured at 20° C and a shear rate of 100 s'1.Embodiment 59.The nutritional composition, the squeezable container, use, or method of any one of Embodiments 54 to 57, wherein the shear viscosity is additional measured about 6 months from the date of manufacture of the nutritional product and wherein the shear viscosity is greater than about 465 mPa s.

[0175] EXAMPLES

[0176] Example 1 - An exemplary blueberry-based pediatric nutritional product.

[0177] Table 1 shows the recipe for an exemplary blueberry-based pediatric nutritional composition that was prepared, and the viscosity analyzed as described in Example 3.

[0178] The recipe included banana puree and blueberry puree as real food at 53% by weight of the total nutritional composition. The recipe includes 4% protein by weight of the total nutrition composition. The recipe provided a PDCAAS of 1.

[0179] The Mineral Mix included calcium citrate, tricalcium phosphate, Trimagnesium citrate, ferrous sulfate, zinc sulfate, sodium molybdate, chromium trichloride, and maltodextrin.

[0180] The Vitamin Mix included potassium iodide, sodium selenate, vitamins A, D3, E, KI, Bl, B2, B6, B9, B5, B12, B7, nicotinamide, inositol, taurine and maltodextrin.

[0181] The recipe provided 1.4 kcal / ml and is formulated to provide to a patient aged 1 year to less than 4 years all nutritional requirements in 5 servings of 150 ml, a patient aged 4 years to less than 7 years all nutritional requirements in 7 servings of 150 ml, and a patient aged 7 years to less than 15 years all nutritional requirements in 9 servings of 150 ml. The macro-nutrients provided by the recipe are calculated in Table 2.

[0182] The exemplary amino acid profile of the nutritional product is provided in Table

[0183] The pH was 4.1-4.2

[0184] Example 2 - An exemplary mango-based pediatric nutritional product.

[0185] Table 4 shows the recipe for an exemplary mango-based pediatric nutritional product that was prepared, and the viscosity analyzed as described in Example 3.

[0186] The exemplary amino acid profile of the nutritional product is provided in Table 5

[0187] The recipe included banana puree and mango puree as real food at 53% by weight of the total nutritional composition. The recipe included 4% protein by weight of the total nutrition composition. The recipe provided a PDCAAS of 1.

[0188] The Mineral Mix included calcium citrate, tricalcium phosphate, Trimagnesium citrate, ferrous sulfate, zinc sulfate, sodium molybdate, chromium trichloride, and maltodextrin.

[0189] The Vitamin Mix included potassium iodide, sodium selenate, vitamins A, D3, E, KI, Bl, B2, B6, B9, B5, Bl 2, B7, nicotinamide, inositol, taurine and maltodextrin.

[0190] The recipe provided 1.4 kcal / ml and is formulated to provide to a patient aged 1 year to less than 4 years all nutritional requirements in 5 servings of 150 ml, a patient aged 4 years to less than 7 years all nutritional requirements in 7 servings of 150 ml, and a patient aged 7 years to less than 15 years all nutritional requirements in 9 servings of 150 ml. The macro-nutrients to be provided by the recipe are calculated in Table 6.

[0191] The pH was 4.1-4.2.

[0192] Example 3 - Viscosities of the exemplary blueberry-based and mango-based pediatric nutritional products prepared in accordance with the recipes of Example 1 and Example 2 are provided in Table 7.

[0193] The shear viscosities were measured with an Anton Paar 302e Physica rheometer with cup and bob CC27 geometry. The viscosities were measured at 20°C with a shear rate of 100 s'1. The viscosities were measured 19 days after the date of manufacture of the nutritional products.

[0194] Example 4 - An exemplary blueberry-based pediatric nutritional product.

[0195] Table 8 shows the recipe for an exemplary blueberry-based pediatric nutritional product where the nutritional product is to be formulated to include no more than 0.2% by weight of a free amino acid.

[0196] The recipe is to be formulated to include banana puree and blueberry puree as real food at 53% by weight of the total nutritional composition. The recipe includes 4% protein by weight of the total nutrition composition. The recipe is to be formulated to provide a PDCAAS of 1 as is calculated from the concentration of protein and free amino acid (L-Lysine) that is to be included.

[0197] The Mineral Mix is to include calcium citrate, tricalcium phosphate, Trimagnesium citrate, ferrous sulfate, zinc sulfate, sodium molybdate, chromium trichloride, and maltodextrin.

[0198] The Vitamin Mix is to include potassium iodide, sodium selenate, vitamins A, D3, E, KI, Bl, B2, B6, B9, B5, B12, B7, nicotinamide, inositol, taurine and maltodextrin.

[0199] The recipe is to be formulated to provide 1.4 kcal / ml and is formulated to provide to a patient aged 1 year to less than 4 years all nutritional requirements in 5 servings of 150 ml, a patient aged 4 years to less than 7 years all nutritional requirements in 7 servings of 150 ml, and a patient aged 7 years to less than 15 years all nutritional requirements in 9 servings of 150 ml. The macro-nutrients to be provided by the recipe are calculated in Table 9.

[0200] The exemplary amino acid profile to be provided by the nutritional product is provided in Table 10.

[0201] The pH of the nutritional product is to be adjusted to below pH 4.2, in the range of pH 4.1-4.2.

[0202] The nutritional product is expected to have a viscosity like the viscosities of the nutritional products Examples 1 and Example 2 when measured under the conditions of Example 3, e.g. in the range of about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1.

[0203] Example 5 - An exemplary mango-based pediatric nutritional product.

[0204] Table 11 shows the recipe for an exemplary mango-based pediatric nutritional product where the nutritional product is to be formulated to include no more than 0.2% by weight of a free amino acid.

[0205] The recipe is to be formulated to include banana puree and mango puree as real food at 53% by weight of the total nutritional composition. The recipe includes 4% protein by weight of the total nutrition composition. The recipe is to be formulated to provide a PDCAAS of 1 as is calculated from the concentration of protein and free amino acid (L-Lysine) that is to be included.

[0206] The Mineral Mix is to include calcium citrate, tricalcium phosphate, Trimagnesium citrate, ferrous sulfate, zinc sulfate, sodium molybdate, chromium trichloride, and maltodextrin.

[0207] The Vitamin Mix is to include potassium iodide, sodium selenate, vitamins A, D3, E, KI, Bl, B2, B6, B9, B5, B12, B7, nicotinamide, inositol, taurine and maltodextrin.

[0208] The recipe is to be formulated to provide 1.4 kcal / ml and is formulated to provide to a patient aged 1 year to less than 4 years all nutritional requirements in 5 servings of 150 ml, a patient aged 4 years to less than 7 years all nutritional requirements in 7 servings of 150 ml, and a patient aged 7 years to less than 15 years all nutritional requirements in 9 servings of 150 ml. The macro-nutrients provided by the recipe are calculated in Table 12.

[0209] The exemplary amino acid profile to be provided by the nutritional product is provided in Table 13.

[0210] The pH of the nutritional product is to be adjusted to below pH 4.2, in the range of pH 4.1-4.2.

[0211] The nutritional product is expected to have a viscosity like the viscosities of the nutritional products Examples 1 and Example 2 when measured under the conditions of Example 3, e.g. in the range of about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1.

Claims

We claim:

1. A nutritional composition comprising at least one real food, the nutritional composition further comprising at least one plant protein, the nutritional composing having(a) a protein level of between 3.6 g and 5.4 g per 100 ml of the nutritional composition; and(b) a caloric density of between 1.3 kcal / ml and 1.5 kcal / ml of the nutritional composition; wherein the nutritional composition has(i) a protein digestibility-corrected amino acid score (PDCAAS) of 1,(ii) a pH of between 3.5 and 4.5, and(iii) does not comprise any milk proteins.

2. The nutritional composition of claim 1, wherein the nutritional composition does not comprise a free amino acid.

3. The nutritional composition of claim 1 or claim 2, wherein the PDCAAS is determined substantially on the basis of the at least one plant protein.

4. The nutritional composition of claim 1 , wherein the nutritional composition comprises no more than about 0.2% by weight of at least one free amino acid(s).

5. The nutritional composition of claim 4, wherein the PDCAAS is determined on the basis of the at least one plant protein and the free amino acid(s).

6. The nutritional composition of any one of claims 1 to 5, wherein the nutritional composition has a shear viscosity between(a) about 260 millipascal-second (mPa s) and about 460 mPa s;(b) about 280 mPa s and about 440 mPa s;(c) about 300 mPa s and about 420 mPa s; or(d) about 315 mPa s and about 405 mPa s, when measured at 20°C and a shear rate of 100 s'1.

7. The nutritional composition of claim 6, wherein the shear viscosity is measured(a) less than about 4 weeks from the date of manufacture of the nutritional composition;(b) less than about 3 weeks from the date of manufacture of the nutritional composition; or(c) between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.

8. The nutritional composition of claim 7, wherein the shear viscosity is additionally measured at about 6 months from the date of manufacture of the nutritional composition and wherein the shear viscosity is greater than about 420 mPa s, greater than about 450 mPa s, or greater than about 465 mPa s, and wherein the shear viscosity is measured at at 20°C and a shear rate of 100 s'1.

9. The nutritional composition of any one of claims 1 to 8, wherein the nutritional composition comprises at least 40% by weight real food or between 40% to 60% by weight real food.

10. The nutritional composition of claim 9, comprising at least(a) 45% real food;(b) 50% real food; or(c) 53% real food.

11. The nutritional composition of any one of claims 1 to 10, wherein in the at least one real food is at least one fruit.

12. The nutritional composition of claim 11, wherein the real food consists of one or more fruits, preferably wherein the one or more fruits are in the form of a fruit puree.

13. The nutritional composition of claim 12, wherein the one or more fruits are a combination of banana and blueberry or banana and mango.

14. The nutritional composition of any one of claims 1 to 13, having a protein level of about 4.5 g per 100 ml of the nutritional composition and a caloric density of about 1.4 kcal / ml of the nutritional composition.

15. The nutritional composition of any one of claims 1 to 14, wherein the nutritional composition is nutritionally complete.

16. The nutritional composition of claim 15, wherein a single dose of the nutritional composition is(a) between 155 g / serving and 165 g / serving; or(b) about 163 g / serving.

17. The nutritional composition of claim 15, wherein a single dose of the nutritional composition is(a) 145 ml / serving and 155 ml / serving; or(b) about 150 ml / serving.

18. The nutritional composition of any one of claims 15 to 17, which provides one day’s nutritional requirement for a subject, wherein the subject is a young child, child and / or an older child.

19. The nutritional composition of claim 18, wherein(a) the subject is a young child and wherein the nutritional composition provides one day’s nutritional requirement in up to 5 servings;(b) the subject is a child and wherein the nutritional composition provides one day’s nutritional requirement in up to 7 servings; and / or(c) the subject is an older child and wherein the nutritional composition provides one day’s nutritional requirement in up to 9 servings.

20. The nutritional composition of claim 18 or claim 19, wherein(a) the subject is a young child and the nutritional composition provides one day’s nutritional requirement in about 713 ml to about 787 ml;(b) the subject is a child and the nutritional composition provides one day’s nutritional requirement in about 1102 ml to about 998 ml; or(c) the subject is an older child and the nutritional composition provides one day’s nutritional requirement in about 1282 ml to about 1396 ml; of the nutritional composition.

21. The nutritional composition of any one of claims 1 to 20, wherein the at least one plant protein is(a) pea protein, rice protein or a combination thereof; or(b) a combination of pea protein and rice protein.

22. The nutritional composition of claim 21, wherein the at least one plant protein is a combination of pea protein and rice protein, and wherein the pea protein is a combination of intact and hydrolyzed protein and the rice protein is intact protein.

23. The nutritional composition of any one of claims 1 to 22, wherein the nutritional composition is packaged in a squeezable container.

24. The nutritional composition of claim 23, wherein the squeezable container has a spout of diameter from(a) about 8 mm to 9 mm; or(b) about 8.5 mm to about 8.6 mm.

25. A squeezable container having a spout of diameter from about 8 mm to 9 mm, preferably about 8.5 mm to about 8.6 mm, comprising a nutritional composition as defined in any one of Embodiments 1 to 22.

26. The nutritional composition of any one of claims 1 to 24 for use in the treatment or prevention of malnutrition.

27. The nutritional composition of any one of claims 1 to 24 for use in the dietary management of malnutrition.

28. The nutritional composition of any one of claims 1 to 24 for use in inducing weight gain in a young child, child or older child having malnutrition or at risk of developing malnutrition.

29. The nutritional composition of any one of claims 1 to 24 for use in preventing malnutrition in a young child, child or older child having decreased appetite.

30. The nutritional composition of any one of claims 1 to 24 for use in improving the nutritional status of a young child, child or older child having decreased appetite.

31. The nutritional composition of any one of claims 26 to 30, wherein malnutrition is associated with cystic fibrosis, congenital heart disease, or cancer.

32. The nutritional composition, the squeezable container, use, or method of any one of the preceding claims, wherein the nutritional composition has a shear viscosity of between about 315 mPa s and about 405 mPa s, wherein the shear viscosity is measured at 20°C and a shear rate of 100 s’1, and wherein the shear viscosity is measured between about 2 to about 3 weeks from the date of manufacture of the nutritional composition.

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