Compositions and methods for treating and preventing inflammation and malnutrition

Abstract

Provided herein are compositions and methods for treating and preventing inflammation and malnutrition. In particular, provided herein are compositions comprising spirulina and microalgae or marine oils and use of such compositions, for example, as nutritional supplements and meal replacements for use in treating and preventing disease, inflammation, and malnutrition.

Description

[0001] COMPOSITIONSAND METHODS FOR TREATING AND PREVENTING INFLAMMATION AND MALNUTRITION

[0002] STATEMENT OF RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 672,478, filed July 17, 2024, the entire contents of which are incorporated herein by reference for all purposes.

[0004] Field

[0005] Provided herein are compositions and methods for treating and preventing inflammation and malnutrition. In particular, provided herein are compositions comprising spirulina and microalgae or marine oils and use of such compositions, for example, as nutritional supplements and meal replacements for use in treating and preventing disease, inflammation, and malnutrition.

[0006] Background

[0007] In low- and middle-income countries, there is a growing demand for nutrient-dense protein sources as populations rise. The global food system and primarily protein sources account for about 30% of total greenhouse gas emissions. Alternative protein sources present an opportunity to address both by providing affordable, nutrient-dense protein sources and mitigating climate change by reducing greenhouse gas emissions.

[0008] There is also a need for alternative sources of essential fatty acids (EFAs) to address malnutrition and particularly, to support optimal growth and development in children, as well as prevent inflammation and optimize brain development and function at all ages. EFAs including omega-3 and omega-6 highly unsaturated fatty acids (HUFA’s) cannot be synthesized by the human body and must be obtained from dietary sources for proper brain development, immune function, and overall health. Inadequate EFA status has been linked to reduced cognitive function, social isolation, aggression and hyperinllammatory responses in children and adults. Currently, global supplies of EFA’s and omega-3 HUFA’s are rapidly diminishing due to overfishing, climate change, aquacultural limitations, dietary shifts and agricultural practices. Consequently, there is an urgent need for alternative sources of EFA’s. What is needed are alternative nutrition sources with high levels of EFAs and proteins with complete amino acid profiles.

[0009] Summary

[0010] By combining the omega-6 EFA, gamma linolenic acid (GLA), and protein enriched spirulina and omega-3 HUFA containing microalgae or marine oils in a nutritional supplement or food source, the present disclosure provides optimal ratios of proteins and essential fatty acid to offer a high protein and anti-inflammatory nutritional solutions that treats and prevents malnutrition, enhance body functions such as increasing muscle mass, augments brain development and function, and reduces inflammation and associated disease.

[0011] For example, in some embodiments, provided herein is a composition, comprising a mixture of spirulina (e.g., Arthrospira platensis) and an microalgae selected from, for example, Nannochloropsis, Schizochytrium, N. oceanica, P. tricornutum, Monodus subterraneus, or Euglena gracilis, wherein the spirulina and the microalgae arc present at a ratio of approximately 1:2 (w / w) (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%). In some embodiments, the ratio is 1:1.97. In some embodiments, the microalgae is Euglena gracilis. In certain exemplary embodiments, the composition comprises gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) and a ratio of 1:0.5 (w / w) (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%). In some embodiments, a ratio of GLA to EPA of 1:0.5 is achieved with a combination of spirulina and marine oil.

[0012] In certain embodiments, the composition is a pharmaceutical composition (e.g., a medical food, or a pharmaceutical). In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable carrier.

[0013] In some embodiments, the composition is a dietary supplement, food or food product. In some embodiments, the supplement, food, or food product comprises one or more additional components (e.g., including but not limited to, flavorings, sweeteners, colorants, fillers, etc.).

[0014] Exemplary compositions comprise at least 10 grams of protein per serving (e.g., at least 20, 30, 40, or, or more) grams of protein per serving. In some embodiments, the composition comprises 8.4 grams of spirulina and 16.6 grams of Euglena gracilis per serving, 16.9 grams of spirulina and 33.1 grams of Euglena gracilis per serving, or 33.7 grams of spirulina and 66.3 grams of Euglena gracilis per serving (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%). Also provided is the use of a composition described herein, for use in treating or preventing malnutrition, protein deficiency, brain development and function, inflammation, or a disease or condition in a subject.

[0015] Further provided is a method of treating or preventing malnutrition, inflammation, or a disease or condition, comprising administering a composition described herein to a subject in need thereof. In some embodiments, the subject is malnourished. In some embodiments, the subject is not malnourished. In some embodiments, the subject is an athlete. In some embodiments, the subject is between the ages of 6 months and 2 year s. In some embodiments, the subject is elderly. In some embodiments, the subject is not an adult. In some embodiments, the subject is not adequately nourished. In some embodiments, one or more servings of the composition are administered one or more times per day (e.g., 1, 2, 3,4, or more times per day) for a period of one day to one year or longer (e.g., one week to 6 months, two weeks to 6 months, one week to one year, or indefinitely).

[0016] Additional embodiments are described herein.

[0017] Description of the Drawings

[0018] FIG. 1A shows a macronutrient profile of spirulina. FIG. IB shows a micronutrient profile of spirulina.

[0019] FIG. 2 shows an amino acid profile of spirulina and ideal amino acid consumption by age FIG. 3 shows a fat profile of spirulina.

[0020] FIG. 4 shows a table with examples of quantities and ratio of spirulina and euglena necessary to achieve ideal protein and EFA content.

[0021] Definitions

[0022] Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments described herein, some preferred methods, compositions, and materials are described herein. However, before the present materials and methods are described, it is to be understood that this invention is not limited to the particular molecules, compositions, methodologies or protocols herein described, as these may vary in accordance with routine experimentation and optimization. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope of the embodiments described herein.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. However, in case of conflict, the present specification, including definitions, will control. Accordingly, in the context of the embodiments described herein, the following definitions apply.

[0024] As used herein and in the appended claims, the singular forms “a”, “an” and “the” include plural reference unless the context clearly dictates otherwise.

[0025] As used herein, the term “about,” when referring to a value or to an amount of mass, weight, time, volume, concentration or percentage is meant to encompass variations of in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate to perform the disclosed method. As used herein, the terms “comprise”, “include”, and linguistic variations thereof denote the presence of recited feature(s), element(s), method step(s), etc. without the exclusion of the presence of additional feature(s), element(s), method step(s), etc. Conversely, the term “consisting of’ and linguistic variations thereof, denotes the presence of recited feature(s), element(s), method step(s), etc. and excludes any unrecited feature(s), element(s), method step(s), etc., except for ordinarily-associated impurities. The phrase “consisting essentially of’ denotes the recited feature(s), element(s), method step(s), etc. and any additional feature(s), element(s), method step(s), etc. that do not materially affect the basic nature of the composition, system, or method. Many embodiments herein are described using open “comprising” language. Such embodiments encompass multiple closed “consisting of’ and / or “consisting essentially of’ embodiments, which may alternatively be claimed or described using such language.

[0026] As used herein, the terms “co-administration” and variations thereof refer to the administration of at least two agent(s) or therapies to a subject (e.g., a composition disclosed herein and one or more therapeutic agents). In some embodiments, the co-administration of two or more agents or therapies is concurrent. In other embodiments, a first agent / therapy is administered prior to a second agent / therapy. Those of skill in the art understand that the formulations and / or routes of administration of the various agents or therapies used may vary. The appropriate dosage for co-administration can be readily determined by one skilled in the art. In some embodiments, when agents or therapies arc co-administcrcd, the respective agents or therapies are administered at lower dosages than appropriate for their administration alone. Thus, co-administration is especially desirable in embodiments where the co-administration of two or more agents results in sensitization of a subject to beneficial effects of one of the agents via co- administration of the other agent.

[0027] As used herein, the term “pharmaceutical composition” refers to the combination of an active agent with a earner, inert or active, making the composition especially suitable for therapeutic use.

[0028] The terms “pharmaceutically acceptable” or “pharmacologically acceptable”, as used herein, refer to compositions that do not substantially produce adverse reactions, e.g., toxic, allergic, or immunological reactions, when administered to a subject.

[0029] As used herein, the terms “prevent,” “prevention,” and preventing” may refer to reducing the likelihood of a particular condition or disease state (e.g., inflammation, malnutrition, or another disease or condition) from occurring in a subject not presently experiencing or afflicted with the condition or disease state. The terms do not necessarily indicate complete or absolute prevention. For example “preventing inflammation” refers to reducing the likelihood of inflammation conditions occurring in a subject not presently experiencing or diagnosed with inflammation. The terms may also refer to delaying the onset of a particular condition or disease state (e.g., inflammation or malnutrition) in a subject not presently experiencing or afflicted with the condition or disease state. In order to “prevent inflammation” a composition or method need only reduce the likelihood and / or delay the onset of inflammation or related condition, not completely block any possibility thereof. "Prevention,” encompasses any administration or application of a therapeutic or technique to reduce the likelihood or delay the onset of a disease developing (e.g., in a mammal, including a human). Such a likelihood may be assessed for a population or for an individual.

[0030] As used herein, the terms “treat,” “treatment,” and “treating” refer to reducing the amount or severity of a particular condition, disease state (e.g., inflammation or malnutrition), or symptoms thereof, in a subject presently experiencing or afflicted with the condition or disease state. The terms do not necessarily indicate complete treatment (e.g., total elimination of the condition, disease, or symptoms thereof). "Treatment,” encompasses any administration or application of a therapeutic or technique for a disease (e.g., in a mammal, including a human), and includes inhibiting the disease, arresting its development, relieving the disease, causing regression, or restoring or repairing a lost, missing, or defective function; or stimulating an inefficient process.

[0031] As used herein, the term “omega-3 fatty acid” refers to polyunsaturated fatty acids that have the final double bond in the hydrocarbon chain between the third and fourth carbon atoms from the methyl end of the molecule. Non-limiting examples of omega-3 fatty acids include, 5,8,11,14,17-eicosapentaenoic acid (EPA), 4,7,10,13,16,19-docosahexanoic acid (DHA) and 7,10,13,16,19-docosapentanoic acid (DPA).

[0032] As used herein, the term w / w (weight / weight) refers to the amount of a given substance in a composition on weight basis. For example, a composition comprising 50% w / w carrots means that the mass of the carrots is 50% of the total mass of the composition (i.e., 50 grams of carrots in 100 grams of the composition, such as a mixture of F&V).

[0033] As used herein, the terms “food” and "food products" refer to products and ingredients therefore, taken by the mouth, the constituents of which are active in and / or absorbed by the G.I. tract with the purpose of nourishment of the body and its tissues, refreshment and indulgence, which products are to be marketed and sold to customers for consumption by humans. Examples of foods and food and beverage products include, but are not limited to, tea; spreads; ice cream; frozen fruits and vegetables; snacks including diet foods and beverages; condiments; and culinary aids. In some embodiments, a "food" is a material comprising protein, carbohydrate and / or fat, which is used in the body of an organism to sustain growth, repair and vital processes and to furnish energy. Foods may also contain supplementary substances such as minerals, vitamins and condiments. See Merriam-Webster's Collegiate Dictionary, 10th Edition, 1993.

[0034] As used herein a "food additive" (e.g., as defined by the FDA in 21 C.P.R. 170.3 (e)(1)) includes direct and indirect additives.

[0035] As used herein, a "dietary supplement" is a product that is intended to supplement a diet. In some embodiments, dietary supplements contain little or no calories.

[0036] As used herein, the term "subject" as used herein includes all members of the animal kingdom including mammals, and suitably refers to humans.

[0037] Detailed Description By combining spirulina and a microalgae in a nutritional supplement or food source, the present disclosure provides how to achieve optimal ratios of proteins and essential fatty acid to offer high protein and anti-inflammatory nutritional solution that treats and prevents malnutrition, augments brain development and function, and reduces inflammation and associated disease. In some composition, the microalgae can be replaced by an omega-3 fatty EFA containing marine source.

[0038] Both spirulina and microalgae are low-impact sources of protein, essential amino acids, antioxidants, vitamins, and minerals. By optimizing the ratio of spirulina to microalgae, the present disclosure provides compositions with ant-inflammatory properties. Such compositions find use, for example, in treating and preventing malnutrition and inflammation and enhancing brain development. Exemplary compositions are described herein.

[0039] As shown in Figures 1-3, spirulina is a complete protein source, containing all essential amino acids. It contains 60-90% protein per dry weight, which makes it an excellent source of dietary protein. Spirulina is also among the highest natural source of gamma linolenic acid GLA. GLA and its elongation metabolite, dihomo gamma linolenic acid, have powerful antiinflammatory, anti-cardiovascular disease and vasodilation (anti-hypertensive) properties. As shown in Figure IB, spirulina is also rich in vitamins, including thiamin, riboflavin, and niacin. These vitamins are important for maintaining good health and preventing malnutrition. Spirulina is a good source of minerals, including copper and iron. These minerals are important for maintaining healthy blood and preventing anemia, which is a common problem in people who are malnourished. Spirulina has powerful antioxidant properties, which can help protect against oxidative stress and inflammation. These properties can help prevent chronic diseases that are associated with malnutrition.

[0040] The present disclosure is not limited to a particular source of microalgae. Examples include but arc not limited to, Nannochloropsis, Schizochytrium, N. oceanica, P. tricornutum, Monodus subterraneus, or Euglena gracilis. Omega-3 containing marine oils can also be used in combination with spirulina to obtain an optimal EFA, anti-inflammatory balance. While the present disclosure is exemplified with Euglena gracilis, other algae sources are specifically contemplated.

[0041] Euglena gracilis is rich in protein, with protein content ranging from 40% to 90% of its dry weight and contains essential fatty acids, including high levels of omega-3 essential fatty acids (EFA) such as EPA. Euglena gracilis also has significant levels of vitamin A, vitamin E, and B-complcx vitamins such as thiamine (Bl), riboflavin (B2), and niacin (B3) and minerals such as iron, magnesium, potassium, and calcium. Euglena gracilis contains antioxidants such as beta-carotene and vitamin E, which help protect cells from oxidative damage caused by free radicals.

[0042] For example, in some embodiments, provided herein is a composition, comprising a mixture of spirulina and an microalgae selected from, for example, Nannochloropsis, Schizochytrium, N. oceanica, P. tricornutum, Monodus subterraneus , or Euglena gracilis, wherein the spirulina and the algae are present at a ratio of approximately 1:2 (w / w) (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%). In some embodiments, the ratio is 1:1.97. In some embodiments, the microalgae is Euglena gracilis. In certain exemplary embodiments, the composition comprises gamma linolenic acid (GLA) and eicosapentaenoic acid (EPA) and a ratio of 1:0.5 (w / w) (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%).

[0043] Depending on the age, exemplary compositions comprise at least 10 grams of protein per serving (e.g., at least 20, 30, 40, or, or more) grams of protein per serving. In some embodiments (see Table 1), the composition comprises 8.4 grams of spirulina and 16.6 grams of Euglena gracilis per serving, 16.9 grams of spirulina and 33.1 grams of Euglena gracilis per serving, or 33.7 grams of spirulina and 66.3 grams of Euglena gracilis per serving (e.g., plus or minus 1%, 2%, 3%, 5%, 10%, 15%, or 20%).

[0044] The present disclosure is not limited to a particular formulation. In some embodiments, compositions are formulated as pharmaceutical compositions such as medical foods, dietary supplements, food additives, food products, and foods, including ready to use (RTU) foods and therapeutic supplements.

[0045] Pharmaceutical or medical food compositions will generally be dissolved or dispersed in an acceptable carrier or medium, preferably for oral or topical administration. In certain embodiments, the compositions may be formulated for intravenous, intraarterial, intramuscular, nasal, vaginal, or anal administration, however, in certain embodiments the preferred medium is a milk-based or juice based liquid or a paste.

[0046] The phrases “pharmaceutically or pharmacologically acceptable” refer to molecular entities and compositions that do not produce an adverse, allergic or other untoward reaction when administered to an animal, or human, as appropriate. As used herein, “pharmaceutically acceptable carrier” includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like. The use of such media and agents for pharmaceutically active substances is well known in the art. Except insofar as any conventional media or agent is incompatible with the active ingredients, its use in the therapeutic compositions is contemplated. Supplementary active ingredients, such as other fatty acid supplements, vitamins, minerals, non-steroidal anti-inflammatories, etc. can also be incorporated into the compositions.

[0047] The compositions are generally formulated for oral administration. Such pharmaceutically acceptable forms include, e.g., capsules, particularly gel capsules, or any other form currently used, including cremes, and liquids, for example syrups, suspensions or emulsions, inhalants and the like.

[0048] A liquid formulation will generally consist of a dispersion of the compositions in a suitable liquid carrier(s) for example, water and / or other solvents such as, for example, polyethylene glycols, oils, milk, phospholipids, with, in certain formulations, a suspending agent, emulsifier, preservative, anti-oxidant, flavoring, and / or coloring agents. Preferred ingredients may include any of the following: galactolipids, sphingolipids, lecithins, cellulose, malt or malt extract, gelatin, casein, cholesterol, egg yolk, sodium dodecyl sulfate, benzalkonium chloride, p- hydroxybenzoic acid, vitamin C, vitamin E or alpha-tocopherol. A composition in the form of a dried powder may be prepared using any suitable pharmaceutical camer(s) routinely used for preparing solid formulations. Examples of such carriers include magnesium stearate, starch, lactose, sucrose and cellulose.

[0049] A composition in the form of a capsule can be prepared using routine encapsulation procedures. For example, a dispersion or suspension can be prepared using any suitable pharmaceutical carrier(s), for example aqueous gums, celluloses, silicates or oils and the dispersion or suspension then filled into a soft gelatin capsule.

[0050] Preferably the composition is in unit dose form such as a tablet, capsule, canned drink, paste, or powder.

[0051] The pharmaceutical formulations suitable for ingestion may include sesame oil, evening primrose oil, peanut oil, aqueous propylene glycol, and sterile powders. In all cases it is desirable to keep the formulation sterile and stable under the conditions of manufacture and storage and must be preserved against the contaminating action of microorganisms, such as bacteria and fungi.

[0052] The active compounds may be formulated into a composition in a neutral or salt form. Pharmaceutically acceptable salts, include the acid addition salts and those which are formed with inorganic acids such as, for example, hydrochloric or phosphoric acids, or such organic acids as acetic, oxalic, tartaric, mandelic, and the like. Salts can also be derived from inorganic bases such as, for example, sodium, potassium, ammonium, calcium, or ferric hydroxides, and such organic bases as isopropylamine, trimethylamine, histidine, Procaine and the like. The carrier can also be a solvent or dispersion medium containing, for example, water, ethanol, polyol (for example, glycerol, propylene glycol, and liquid polyethylene glycol, and the like), suitable mixtures thereof, and vegetable oils. The proper fluidity can be maintained, for example, by the use of a coating such as lecithin, by the maintenance of the required particle size in the case of dispersion, and by the use of surfactants. The prevention of the action of microorganisms can be brought about by various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenol, sorbic acid, thimerosal, and the like. In many cases, it will be preferable to include isotonic agents, for example, sugars or sodium chloride. Prolonged absorption of the compositions can be brought about by the use in the compositions of agents delaying absorption, for example, aluminum monostearate and gelatin.

[0053] Sterile compositions are prepared by incorporating the active compounds in the required amount in the appropriate solvent with various of the other ingredients enumerated above, as required, followed by filtered sterilization. Generally, dispersions are prepared by incorporating the various sterilized active ingredients into a sterile vehicle which contains the basic dispersion medium and the required other ingredients from those enumerated above. In the case of sterile powders, the preferred methods of preparation are vacuum-drying and freeze-drying techniques which yield a powder of the active ingredient.

[0054] Upon formulation, the active ingredients will be administered in a manner compatible with the dosage formulation and in such amount as is therapeutically effective. The formulations are easily administered in a variety of dosage forms, such as tablets containing measured amounts of active ingredient, with even drug release capsules and the like being employable. The amounts of active ingredients in the formulations of the present invention will be similar to fatty acid supplements currently available. Those of skill in the art are referred to the Physicians Desk Reference for more comprehensive details on currently used dosages of food supplements. Some variation in dosage will necessarily occur depending on the condition of the subject being treated. The person responsible for administration will, in any event, determine the appropriate dose for the individual subject.

[0055] For dietary or nutraceutical use, the compositions described herein, alone or in combination with other dietary supplements may be formulated into a single or separate pharmaceutically acceptable compositions. Exemplary formulations include a good tasting, milk based drink, or a good tasting, juice based drink or fruit based powder. Such a drink may be contained in cans, preferably cans sealed under nitrogen or other oxidatively inert gas atmosphere. Cans may be packaged in “six packs” held together by plastic or cardboard containers for easy retail sales. The drinks may also be enclosed in individual cardboard or aluminum based or other foil containers, for example, that also provide a straw for each individual container. The drink formulations may also be provided in dried or lyophilized forms for rehydration in milk, water, juice, or other suitable solvent. In certain embodiments, a premeasured liquid container indicating the level of liquid needed for proper rehydration may be included, and in bulk powder containers, a measuring spoon may also be provided. It is also understood that individual packets may be provided that each include enough powder for a single serving.

[0056] The present disclosure is not limited to a particular formulation comprising one or more of the above-described compositions. In some embodiments, compositions are provided as one or more of supplements, food products, foods, and food additives. In some embodiments, foods and food products are one or more of bars (e.g., raw bars), biscuits, crackers, chips, pastes, gruels and liquids beverages, powders, and the like.

[0057] In some embodiments, compositions are shelf-stable or fresh versions of ready-to-use supplementary foods (RUSF), which can be single products or combinations of more than one product that together provide the complete formulation; ready-to-use therapeutic foods (RUTF); which can be single products or combinations of more than one product that together provide the complete formulation; mixes (e.g., powders or pastes) that are used as a composite ingredient to create RUTF and RUSF when combined with local ingredients in countries where malnutrition is prevalent; mixes (e.g., powders or pastes) that are used by individual households to fortify local food preparations. The dietary supplement may comprise one or more inert ingredients, especially if it is desirable to limit the number of calorics added to the diet by the dietary supplement. For example, the dietary supplement may also contain optional ingredients including, for example, herbs, vitamins, minerals, enhancers, colorants, sweeteners, flavorants, inert ingredients, and the like.

[0058] In further embodiments, the compositions comprise at least one food flavoring such as acetaldehyde, acetoin (acetyl methylcarbinol), anethole (parapropenyl anisole), benzaldehyde (benzoic aldehyde), N butyric acid (butanoic acid), d or 1 carvone (carvol), cinnamaldehyde (cinnamic aldehyde), citral (2,6 dimethyloctadien 2,6 al 8, gera nial, neral), decanal (N decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C IO), ethyl acetate, ethyl butyrate, 3 methyl 3 phenyl glycidic acid ethyl ester (ethyl methyl phenyl glycidate, strawberry aldehyde, C 16 aldehyde), ethyl vanillin, geraniol (3,7 dimethyl 2,6 and 3,6 octadien 1 ol), geranyl acetate (geraniol acetate), limonene (d , 1 , and dl ), linalool (linalol, 3,7 dimethyl 1,6 octadien 3 ol), linalyl acetate (bergamol), methyl anthranilate (methyl 2 aminobenzoate), piperonal (3,4 methylenedioxy benzaldehyde, heliotropin), vanillin, alfalfa (Medicago sativa L.), allspice (Pimenta officinalis), ambrette seed (Hibiscus abelmoschus), angelic (Angelica archangelica), Angostura (Galipea officinalis), anise (Pimpinella anisum), star anise (Illicium verum), balm (Melissa officinalis), basil (Ocimum basilicum), bay (Laurus nobilis), calendula (Calendula officinalis), (Anthemis nobilis), capsicum (Capsicum frutescens), caraway (Carum carvi), cardamom (Elettaria cardamomum), cassia, (Cinnamomum cassia), cayenne pepper (Capsicum frutescens), Celery seed (Apium graveolens), chervil (Anthriscus cerefolium), chives (Allium schoenoprasum), coriander (Coriandrum sativum), cumin (Cuminum cyminum), elder flowers (Sambucus canadensis), fennel (Foeniculum vulgare), fenugreek (Trigonella foenum graecum), ginger (Zingiber officinale), horehound (Marrubium vulgare), horseradish (Armoracia lapathifolia), hyssop (Hyssopus officinalis), lavender (Lavandula officinalis), mace (Myristica fragrans), marjoram (Majorana hortensis), mustard (Brassica nigra, Brassica juncea, Brassica hirta), nutmeg (Myristica fragrans), paprika (Capsicum annuum), black pepper (Piper nigrum), peppermint (Mentha piperita), poppy seed (Papayer somniferum), rosemary (Rosmarinus officinalis), saffron (Crocus sativus), sage (Salvia officinalis), savory (Satureia hortensis, Satureia montana), sesame (Sesamum indicum), spearmint (Mentha spicata), tarragon (Artemisia dracunculus), thyme (Thymus vulgaris, Thymus serpyllum), turmeric (Curcuma longa), vanilla (Vanilla planifolia), zedoary (Curcuma zedoaria), sucrose, glucose, saccharin, sorbitol, mannitol, aspartame. Other suitable flavoring arc disclosed in such references as Remington's Pharmaceutical Sciences, 18th Edition, Mack Publishing, p. 1288-1300 (1990), and Furia and Pellanca, Fenaroli's Handbook of Flavor Ingredients, The Chemical Rubber Company, Cleveland, Ohio, (1971), known to those skilled in the art.

[0059] In other embodiments, the compositions comprise at least one synthetic or natural food coloring (e.g., annatto extract, astaxanthin, beet powder, ultramarine blue, canthaxanthin, caramel, carotenal, beta carotene, carmine, toasted cottonseed flour, ferrous gluconate, ferrous lactate, grape color extract, grape skin extract, iron oxide, fruit juice, vegetable juice, dried algae meal, tagetes meal, carrot oil, com endosperm oil, paprika, paprika oleoresin, riboflavin, saffron, tumeric, tumeric and oleoresin).

[0060] In some embodiments, combinations of different supplement pills or combinations of food products and supplements are used to provide complete compositions.

[0061] In some embodiments, commercial or home kitchens or laboratories are used to ensure food safety and prevention of nutrient degradation during storage, including the addition of necessary preservatives and additives and (for shelf-stable products) microbial testing as required by food safety regulations. In some embodiments, compositions are low in water content to achieve microbial safety.

[0062] The compositions and foods described herein find use in a variety of applications related to treating and preventing malnutrition or inflammation. In some embodiments, one or more of the compositions (e.g., a single supplement, a single food, a combination of a supplement and a food, or a combination of multiple foods and beverages) is administered to a subject in need thereof (e.g., a subject suffering from malnutrition or a risk of malnutrition or having inflammation). In some embodiments, the subject is suffering from malnutrition not caused by a wasting disease or condition. In some embodiments, the subject has been suffering from malnutrition for at least one week (e.g., at least one week, one month, one year, etc.)

[0063] In some embodiments, subjects are children (e.g., under the age of 18, under the age of 12, under the age of 10, under the age of 6, under the age of 4, or under the age of 2). In some embodiments, subjects are 2-8 years old (e.g., 2-6, 2-7, 2-5, 2-4, or 2-3 years old. In some embodiments, the subject is not an adult. In some embodiments, subjects are elderly adults (e.g., older than 50, 60, 70, 80, or 90 years) and the administration of the composition prevents or reverses malnutrition associated with aging.

[0064] In some embodiments, the subject is a pregnant woman and the administration of the compositions described herein prevents malnutrition and malnutrition associated cognitive function in the developing embryo or fetus before and / or after birth.

[0065] In some embodiments, one or more servings of the composition is administered one or more times a day (e.g., as a supplement or meal replacement) for a period of several days to several years (e.g., several days, one week, several weeks, one month, several months, one year, or several years) or indefinitely. In some embodiments, the composition is administered until malnutrition is resolved. In some embodiments, the composition is administered until cognitive function is improved to the level of a subject not suffering from malnutrition.

[0066] Experimental

[0067] Example 1

[0068] Spirulina was grown in a bioreactor (e.g., an air lift or bubble column control bioreactor). After growth, macro and micronutrient profiles were determined. Results are shown in FIGs. 1-3.

[0069] All publications, patents, patent applications and accession numbers mentioned in the above specification are herein incorporated by reference in their entirety. Although the invention has been described in connection with specific embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications and variations of the described compositions and methods of the invention will be apparent to those of ordinary skill in the ail and are intended to be within the scope of the following claims.

Claims

Claims1. A composition, comprising a mixture of spirulina and a microalgae selected from the group consisting of Nannochloropsis, Schizochytrium, N. oceanica, P. tricomutum, Monodus subterraneus, and Euglena gracilis, wherein said spirulina and said microalgae are present at a ratio of approximately 1:2 (w / w).

2. The composition of claim 1, wherein said ratio is 1:1.97.

3. The composition of any of the previous claims, wherein said microalgae is Euglena gracilis.

4. The composition of any of the preceding claims, wherein said composition comprises gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) and a ratio of l:0.5(w / w).

5. The composition of any of the preceding claims, wherein said composition is a pharmaceutical composition.

6. The composition of claim 5, wherein said composition is a medical food.

7. The composition of any of the preceding claims, wherein said composition is a dietary supplement.

8. The composition of any of the preceding claims, wherein said composition is a food or food product.

9. A functional food, ready-to-use therapeutic food or ready-to-use food supplement comprising the composition of any one of the preceding claims.

10. The composition of any of the preceding claims, wherein said composition comprises at least 5 grams of protein per serving.11 . The composition of any of the preceding claims, wherein said composition comprises at least 10 grams of protein per serving.

12. The composition of any of the preceding claims, wherein said composition comprises at least 20 grams of protein per serving.

13. The composition of any of the preceding claims, wherein said composition comprises at least 50 grams of protein per serving.

14. The composition of any of the preceding claims, wherein said composition comprises 8.4 grams of spirulina and 16.6 grams of Euglena gracilis per serving.

15. The composition of any of the preceding claims, wherein said composition comprises 16.9 grams of spirulina and 33.1 grams of Euglena gracilis per serving.

16. The composition of any of the preceding claims, wherein said composition comprises 33.7 grams of spirulina and 66.3 grams of Euglena gracilis per serving.

17. The composition of any one of claims 1 to 16 for use in treating or preventing malnutrition in a subject.

18. The composition of any one of claims 1 to 16 for use in treating or preventing inflammation or disease in a subject.

19. A method of treating or preventing malnutrition, comprising administering the composition of any one of claims 1 to 16 to a subject in need thereof.

20. A method of treating or preventing inflammation, comprising administering the composition of any one of claims 1 to 16 to a subject in need thereof.

21. The method of claim 18 or 19, wherein said subject is malnourished.

22. The method of any one of claims 18 to 21, wherein said subject is between the ages of 6 months and 2 years.

23. The method of any one of claims 18 to 21, wherein said subject is elderly.

24. The method of any one of claims 18 to 23, wherein one or more servings of said composition is administered one or more times per day for a period of one day to one year.

25. The method of any one of claims 18 to 23, wherein one or more servings of said composition is administered one or more times per day for a period of one week to 6 months.

26. The method of any one of claims 18 to 23, wherein one or more servings of said composition is administered one or more times per day indefinitely.

27. The method of any one of claims 18 to 26, wherein said subject is not an adult.

28. The method of any one of claims 18 to 27, wherein said subject is not adequately nourished.

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