Nutritional compositions incorporating yeast or extract thereof

Abstract

Embodiments of the present disclosure are directed to nutritional compositions. In at least one embodiment, a nutritional composition comprises a dried yeast component or extract thereof and optionally one or more additives.

Description

Docket No. 38592-15NUTRITIONAL COMPOSITIONS INCORPORATING YEAST OR EXTRACT THEREOFCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 682,055, filed August 12, 2024, the disclosure of which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure is directed to nutritional supplements and, more specifically, to supplements, blends, and other consumables incorporating yeast-based proteins.BACKGROUND

[0003] In response to the increasing global demand for animal protein, the sustainable production of meat and dairy products is constrained by low efficiency, while alternative proteins such as artificial and plant-based meats remain costly and often lack desirable taste. As a result, the production of single-cell proteins (SCP) from microorganisms, including algae, fungi, and bacteria, has garnered significant interest due to their high protein content and sustainability. Polyols including glycerol, a coproduct of biodiesel synsthesis, and methanol, a readily available and easily transportable Cl carbon source, is emerging as an ideal substrate for SCP biosynthesis because of its high reducing power and its production from CO2 and hydrogen drived from water electrolysis.SUMMARY

[0004] The following summary presents a simplified summary of various aspects of the present disclosure in order to provide a basic understanding of such aspects. This summary is not an extensive overview of the disclosure. It is intended to neither identify key or critical elements of the disclosure, nor delineate any scope of the particular embodiments of the disclosure or any scope of the claims. Its purpose is to present some concepts of the disclosure in a simplified form as a prelude to the more detailed description that is presented later.

[0005] One aspect of the present disclosure relates to a nutritional composition comprising a dried yeast component or extract thereof and optionally one or more additives. In at least one embodiment, the dried yeast component or extract thereof is incorporated into the nutritional composition in the form of a powder.Docket No. 38592-15

[0006] A further aspect of the present disclosure relates to a nutritional composition comprising dried yeast component or extract thereof and optionally one or more additives. In at least one embodiment, the dried yeast component or extract thereof is incorporated into the nutritional composition in the form of a powder, the dried yeast component or extract thereof having an angle of repose of less than 40°.

[0007] A further aspect of the present disclosure relates to a nutritional composition comprising dried yeast component or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0008] A further aspect of the present disclosure relates to a nutritional composition comprising dried Pichia pastoris yeast (also known as Komagataella phaffii) or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0009] A further aspect of the present disclosure relates to a nutritional composition comprising a powder comprising: Pichia pastoris or extract thereof; Chlorella vulgaris or extract thereof; spirulina; alfalfa leaf; moringa leaf; and a fruit blend. In at least one embodiment, a beta glucan content of the Pichia pastoris or extract thereof is from about 5% to about 20% by weight.

[0010] A further aspect of the present disclosure relates to dried Pichia pastoris or an extract thereof having: a protein content of about 45% to about 70% by weight excluding moisture, preferably greater than about 55% by weight excluding moisture; a beta glucan content greater than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture; a sugar content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture; a fiber content of about 10% to about 30% by weight excluding moisture; a total fat content less than about 7% by weight excluding moisture, wherein the total fat content comprises about 35% to about 65% by weight of monounsaturated fats and about 15% to 40% by weight of polyunsaturated fats; or a combination thereof.

[0011] A further aspect of the present disclosure relates to a method of forming a powder comprising Pichia pastoris or extract thereof, the method comprising: spray-drying the Pichia pastoris or extract thereof to form the powder.

[0012] A further aspect of the present disclosure relates to a nutritional blend comprising: a dried yeast component or extract thereof of Pichia pastoris present from about 50% by weight to about 90% by weight excluding moisture; and a fruit or vegetable blend present from about 10% by weight to about 50% by weight excluding moisture.Docket No. 38592-15

[0013] A further aspect of the present disclosure relates to a method of forming a beverage comprising adding the nutritional composition or the nutritional blend of any of the aforementioned embodiments.

[0014] A further aspect of the present disclosure relates to a method of providing nutritional benefit to a patient in need thereof comprising administering the nutritional composition or the nutritional blend of any of the aforementioned embodiments to the patient.

[0015] A further aspect of the present disclosure relates to a method of treating malnutrition and to an underweight patient in need thereof comprising administering the nutritional composition or the nutritional blend of any of the aforementioned embodiments to the patient.

[0016] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. Thus, for example, reference to “a protein” can include a single protein, multiple proteins of a single type, and mixtures of two or more different proteins.

[0017] Also as used herein, the term “about” in connection with a measured quantity, refers to the normal variations in that measured quantity, as expected by one of ordinary skill in the art in making the measurement and exercising a level of care commensurate with the objective of measurement and the precision of the measuring equipment. In at least one embodiment, the term “about” includes the recited number ±1%, such that “about 10” would include 9.9 to 10.1 and all values in between.

[0018] Also as used herein, “protein” has its ordinary and customary meaning in the art and includes, and refers to a polypeptide (i.e., a string of at least two amino acids linked to one another by peptide bonds). Polypeptides may include natural amino acids, non-natural amino acids, synthetic amino acids, amino acid analogs, and combinations thereof. The term “peptide” is typically used to refer to a polypeptide having a length of less than about 50 amino acids.Proteins may include moieties other than amino acids (e.g., glycoproteins) and may be processed or modified. A protein can be a complete polypeptide chain as produced by a cell, or can be a functional portion thereof. A protein can include more than one polypeptide chain which may be chemically linked (e.g., by a disulfide bond), non-chemically linked (e.g., by hydrogen bonding), or both. Polypeptides may contain L-amino acids, D-amino acids, or both, and may contain any of a variety of amino acid modifications or analogs known in the art.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which:Docket No. 38592-15

[0020] FIG. 1 shows an amino acid profile for various Pichia pastoris yeast produced in accordance with the embodiments described herein.DETAILED DESCRIPTION

[0021] Embodiments of the present disclosure relate to nutritional supplements, blends, and other consumables incorporating yeasts or yeast-based extracts and / or proteins. For example, certain embodiments of the present disclosure relate to a nutritional composition that includes a dried yeast component or an extract thereof, with the optional inclusion of one or more additives. This composition can be formulated in various forms suitable for consumption, such as powder, encapsulated powder, tablets, granules, pellets, or bars. In at least one embodiment, composition comprises dried Pichia pastoris yeast or an extract thereof. While Pichia pastoris is exemplified throughout the application, it is contemplated that, in variations of the embodiments described herein, other yeasts may be utilized in lieu of or in addition to Pichia pastoris, including, but not limited to, Saccharomyces cerevi iae, Kluyveromyces marxianus, Candida ulilis, Hansenula polymorpha, and Yarrowia lipolytica.

[0022] Pichia pastoris a methylotrophic yeast that was first discovered in France in 1919. It offers natural advantages for methanol transformation. In the 1960s, Philips Petroleum initially used Pichia pastoris for single-cell protein (SCP) production as an animal feed additive, but the process became economically unviable after the 1973 oil crisis. Since the 1980s, however, Pichia pastoris has emerged as a leading platform for recombinant protein expression, surpassing Saccharomyces cerevisiae as the most widely used eukaryotic host. To date, over 5,000 proteins have been expressed using this yeast, and several products have been approved by regulatory agencies such as the EMA, EFSA, and FDA. Pichia pastoris is valued for its ability to produce both high-value biopharmaceuticals (such as antibodies and vaccines) and low-cost food enzymes. With the increasing focus on a circular and sustainable bioeconomy, this yeast is considered pivotal due to its capacity to utilize renewable raw materials and waste streams to generate biomass and customized biotechnological products, thereby contributing to more environmentally friendly and efficient industrial processes.

[0023] Pichia pastoris is capable of growing on many carbon sources, including but not limited to glycerol, methanol, and glucose. In at least one embodiment, Pichia pastoris is cultivated in a bioreactor using fed-batch, fill and draw, or continuous mode processes known in the art. Typically, a small bolus of live Pichia pastoris yeast fermentation broth is added to the bioreactor under agitation. Oxygen is supplied in the form of air or pure oxygen via spargers or other means understood in the art. Carbon sources such as dextrose, glucose, glycerol, methanol, or combinations thereof can be added in a carbon-limited manner to avoid buildup, along withDocket No. 38592-15 other nutrients including nitrogen, usually in the form of ammonia salts. The yeast is generally grown at a cell density ranging from 50 g / L to 120 g / L dry cell weight (DCW), with a specific growth rate ranging from 0.002 gram / gram to 0.11 gram / gram. After fermentation, Pichia pastoris yeast may be separated from the fermentation broth to achieve a concentration optimized for downstream drying processes using methods such as transverse flow filtration (TFT), filter pressing, centrifugation, continuous centrifugation, vacuum drum filtration, vacuum disk filtration, clarification, and precipitation. These processes can increase the yeast concentration by 2-4 times or higher, reaching approximately 100 g / L to 500 g / L DCW.

[0024] As used herein, “fermentation broth” refers to an aqueous solution / suspension comprising whole cells, water, media, biomolecules excreted by the whole cells, and other constituents within the fermentation vessel. The broth can be separated into the whole cell fraction and a cleaned fermentation broth. The cleaned fermentation broth comprises water, media, biomolecules excreted by the cells, and other constituents.

[0025] Prior to drying, Pichia yeast may undergo intermediary processes that reduce cell viability and increase digestibility by facilitating cell wall rupture, resulting in a yeast extract. In this process, the yeast cell walls are ruptured (lysed), and the soluble portion of the yeast lysate may or may not be separated from the insoluble portions, which primarily comprise the yeast cell wall, using methods known in the art. These processes include, but are not limited to: (1) mechanical disruption, such as high-pressure cell disruption where cells are passed through a high-pressure gradient causing cell wall rupture; (2) thermal disruption, where the yeast is subjected to elevated temperatures between 55°C and 65°C for 30 minutes to 16 hours in a solution capable of activating intrinsic enzymes that digest yeast components; and (3) lysis via chemical means or osmotic pressure, as known in the art.

[0026] The separated Pichia yeast or extracts thereof may be dried into a powder. Drying processes include, but are not limited to, spray drying and drum drying, which may optionally include a grinding step. The properties of the dried yeast are critical to cell viability and flowability necessary for downstream processing and safety. Specifically, 100% of the dried yeast powder must pass through a 14 mesh screen and 50% must pass through a 30 mesh screen. Furthermore, moisture levels should be less than or equal to 5% by weight, and more preferably less than 2% by weight, with an angle of repose of less than or equal to about 40°. For example, angle of repose may be about 20°, about 25°, about 30°, about 35°, about 40°, or within any range defined by and inclusive of these values (e.g., from about 20° to about 30°). Angle of repose is a measure of the maximum angle at which a pile of powder remains stable without slumping, and it serves as an important indicator of powder flowability. A lower angle of repose generally corresponds to better flow properties, meaning the powder will move more easilyDocket No. 38592-15 during handling and processing. Angle of repose, as referred to herein, is measured per U.S. Pharmacopeia (USP) <1174>, available at www.usp.org, which is hereby incorporated by reference herein in its entirety. Flow property for different angles of repose may be characterized as follows: excellent flow corresponds to 25° to 30°; good corresponds to greater than 30° to 35°; fair without the need of flow aid corresponds to greater than 35° to 40°; passable corresponds to greater than 40° to 45°; poor (which requires agitation or vibration) corresponds to greater than 45° to 55°; very poor corresponds to greater than 55° to 65°; and extremely poor corresponds to greater than 65°.

[0027] In various embodiments, it is preferable that the yeast cells are rendered unviable as measured by colony forming units (CFUs) after optional intermediate processes and drying described above. In at least one embodiment, about 90% or more of the yeast cells are rendered unviable. In at least one embodiment, about 91% or more, about 92% or more, about 93% or more, about 94% or more, about 95% or more, about 96% or more, about 97% or more, about 98% or more, about 99% or more, about 99.5% or more, or about 99.9% or more of the yeast cells are rendered unviable. Various methods may be utilized to render yeast cells unviable, such as thermal inactivation. Thermal inactivation may be performed by subjecting the yeast cells to elevated temperatures during processes like spray drying, drum drying, or oven drying. In at least one embodiment, the yeast cells have a cell viability of less than about 10 x 105CFU / g, about 9 x 105CFU / g, about 8 x 105CFU / g, about 7 x 105CFU / g, about 6 x 105CFU / g, about 5 x 105CFU / g, about 4 x 105CFU / g, about 3 x 105CFU / g, about 2 x 105CFU / g, about1 x 105CFU / g, less than about 1 x 105CFU / g, or within any range defined by and inclusive of any of these values (e.g., from about 3 x 105CFU / g to about 7 x 105CFU / g).

[0028] Table 1 shows cell viabilities after various pretreatments, but prior to spray-drying. The procedures for thermal shock, high-pressure cell disruption, and slow pasteurization are described in below in Example 2. Table 2 shows cell viabilities for the various pre-treatments after spray-drying for different substrate compositions.Table 1 : Quantification of cell viability after pretreatments and before spray-dryingDocket No. 38592-15Table 2: Quantification of cell viability after spray-drying

[0029] The resultant particle sizes of dried powder of Pichia pastoris or extracts thereof may range from about 1 micrometers to about 1000 micrometers, as measurable by electron microscopy. A target particle size may be achieved by varying parameters associated with a spray-drying process. In at least one embodiment, the mean particle size is less than about 1000 micrometers, less than about 600 micrometers, less than about 300 micrometers, less than about 150 micrometers down to about 100 micrometers, about 75 micrometers, about 10 micrometers, about 5 micrometers, about 1 micrometer, or within any range defined by and inclusive of any of these values (e.g., from about 75 micrometers to about 300 micrometers).

[0030] In at least one embodiment, the dried yeast component or extract thereof (e.g., Pichia pastoris in powder form) may be compounded (mixed) together with other edible additives.Such additives can include, but are not limited to, microorganisms such as microalgae or cyanobacteria, including but not limited to spirulina, Arthrospira platensis, Arthospira fiisiformis, Arthrospira maxima, Chlorella vulgaris, tetraselmis, isochrysis, or nanochloropsis.

[0031] In at least one embodiment, the additives may include one or more yeasts, including, but not limited to, Baker’s yeast, Brewer’s yeast, Saccharomyces cerevisiae, Saccharomyces boulardii, Torula yeast, Candida utilis, Yarrowia lipolytica, or Cenovis.

[0032] In at least one embodiment, the additives may include one or more probiotic bacteria, including, but not limited to, Lactobacillus acidophilus, Lactobacillus ramnosis, LactobacillusDocket No. 38592-15 paracasei, Lactobacillus plantarum, Bifidobacterium bifidum, Bifidobacterium lactis, or Lactococcus lactis.

[0033] In at least one embodiment, the additives may include one or more flavorings, including, but not limited to, chocolate, vanilla, hazelnut, peanut, almond, coconut, banana, strawberry, blueberry, watermelon, and mint.

[0034] In at least one embodiment, the additives may include fruit blends. The fruit blends may be blends of one or more fruits, including, but not limited to, acerola, blueberry powder, bilberry powder, strawberry powder, cranberry powder, and pomegranate powder.

[0035] In at least one embodiment, the additives may include binders, including, but not limited to, desiccants, flow additives, silicon dioxide, magnesium stearate, and talc.

[0036] In at least one embodiment, the additives may include protein concentrate, including, but not limited to, whey protein, soy protein isolate, and pea protein.

[0037] In at least one embodiment, the additives may include powder or extract thereof of dried plant, herb, mushroom, berry, groundnut, nut, or seed, including but not limited to cocoa, vanilla, acai berry, banana, blueberry, blueberry skin, chia seed, pumpkin seed, peanut, almond, walnut, hazelnut, pistachio, basil, garlic, coconut, kale, flax seed, hemp seed, butternut squash seed, sesame seed, sunflower seed, pomegranate seed, pine nuts, quinoa, coffee, kola nut, beet powder, Rhodiola Rosea, Bacopa Monnieri, Ginseng, Ginkgo Biloba, Saw palmetto, Lions Mane mushroom, Reishi mushroom, Turkey tail, Cordyceps militaris, Ashwagandha root, Tribulus terrestrius, Safed musli root, Maca root, Shilagit root, Black pepper extract, Moringa leaf, and alfalfa.

[0038] In at least one embodiment, the additives may include collagen powder or collagen peptides.

[0039] In at least one embodiment, the additives may include vitamins and minerals, including, but not limited to, caffeine, thiamin, riboflavin, niacin, pantothenic acid, pyroxine, biotin, folate, cyanobalamin, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin K, calcium salts, powdered eggshells, magnesium salts, zinc salts, potassium salts, iron salts, phosphorous salts, selenium salts, beta glucan, cellulose, and creatine phosphate.

[0040] In at least one embodiment, the additives may include essential amino acids, including, but not limited to, L-citrulline, L-arginine, L-ornithine, methionine, tryptophan, threonine, histidine, lysine, leucine, valine, and phenylalanine.

[0041] In at least one embodiment, the yeast powder is disposed within a digestible capsule, compressed into a tablet and / or granule, or extruded into a pellet such that the capsule, tablet, granule, or pellet may be consumed by a human as a dietary supplement or by an animal as anDocket No. 38592-15 animal feed. In at least one embodiment, the powder may be combined with fruit, nuts, binders, chocolate, or other components and formed into a nutritional bar or other form factor.

[0042] In at least one embodiment, yeast powder (e.g., Pichia pastoris or extract thereof in powder form) and one or more additives may be contained in a bag, a bottle, a can, or other container, such that the powder can be consumed directly by humans or animals, or may be added to other food or beverages. In at least one embodiment, beverages may be pre-formulated or formulated in situ (e.g., home-made smoothies). Such beverages may include Pichia pastoris powder in addition to a liquid selected from water, milk, soy milk, oat milk, almond milk, coffee, teas, and fruit juices. The beverage may optionally include other ingredients including but not limited to yogurt, sweeteners including honey and sugar, protein powders including whey protein and pea protein, collagen and collagen peptides, additional vitamins and minerals, powdered nutritional herbs / berries / fruits / vegetables / mushrooms or extracts thereof, probiotics, prebiotics, caffeine, algae, amino acids, or combinations thereof.

[0043] In at least one embodiment, the macronutritional and micronutritional constituents of Pichia pastoris yeast can be modulated by the specific protocols used, particularly the composition of the feed media during growth. For example, the total protein content of Pichia pastoris grown with a glycerol feed is approximately 45-50% by weight (excluding moisture), and this increases to about 60-65% by weight when a methanol carbon source is used. Protein content can be measured using various methods known in the art, such as total nitrogen composition, the Lowry assay, and the Bradford assay. As referred to herein, total protein content is determined using the total nitrogen composition method. In at least one embodiment, the protein content of the yeast component (e.g., Pichia pastoris) or extract thereof is (excluding moisture) about 35% by weight, about 36% by weight, about 37% by weight, about 38% by weight, about 39% by weight, about 40% by weight, about 41% by weight, about 42% by weight, about 43% by weight, about 44% by weight, about 45% by weight, about 46% by weight, about 47% by weight, about 48% by weight, about 49% by weight, about 50% by weight, about 51% by weight, about 52% by weight, about 53% by weight, about 54% by weight, about 55% by weight, about 56% by weight, about 57% by weight, about 58% by weight, about 59% by weight, about 60% by weight, about 61% by weight, about 62% by weight, about 63% by weight, about 64% by weight, about 65% by weight, about 66% by weight, about 67% by weight, about 68% by weight, about 69% by weight, about 70% by weight, or within any range defined by and inclusive of any of these values (e.g., from about 45% by weight to about 65% by weight).

[0044] The amino acid composition of the protein was analyzed and found to contain 20 amino acids typically present in eukaryotes (with the exception of selenocysteine, the twenty -Docket No. 38592-15 first amino acid, which was not measured). Essential amino acids are those that cannot be synthesized by humans. Of the twenty amino acids common to all life forms (excluding selenocysteine), humans are unable to synthesize nine: histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine. Proteins that contain all essential amino acids are considered complete. In various embodiments described herein, the amino acid profile of Pichia pastoris protein present in the nutritional compositions was measured and found to include all essential amino acids, making it a complete protein source.

[0045] As used herein, “media” refers to a solution comprising the carbon and chemical energy source (typically one or more of glucose, sugars, methanol, glycerol, or other carbon containing molecules), water, and optionally one or more of nitrogen containing molecules (e.g., ammonia salts), phosphate, and other salts and nutrients, including optional yeast extract, needed to promote microbial growth.

[0046] It was found that Pichia pastoris is rich in beta glucan, with the content of beta glucan being modulated by the carbon source used as feed. Glycerol-fed Pichia pastoris contains approximately 8% beta glucan by weight, while methanol-fed Pichia pastoris contains approximately 12% beta glucan by weight. Beta glucan is a polysaccharide fiber found in the cell wall of Pichia pastoris yeast and is known to have significant health benefits, including but not limited to: (1) reduction of blood pressure, blood glucose concentration, and cholesterol; (2) improvement of immune function; (3) slowing sugar uptake from the digestive system into the bloodstream, reducing insulin spikes, and lowering the risk of metabolic syndrome, type 2 diabetes, and obesity; (4) potential reduction in the risk of certain cancers; and (5) reduction in the incidence and symptoms of colitis and other autoimmune diseases.

[0047] In at least one embodiment, the dried yeast component or extract thereof (e.g., Pichia pastoris) has a beta glucan content greater than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture. In at least one embodiment, the yeast component or extract thereof has a beta glucan content of (excluding moisture) about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, about 20% by weight, about 21% by weight, about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight, about 27% by weight, about 28% by weight, about 29% by weight, about 30% by weight, or within any range defined by and inclusive of any of these values (e.g., from about 3% by weight to about 20% by weight).Docket No. 38592-15

[0048] It has been found that Pichia pastoris contains certain B vitamins, with glycerol-fed Pichia pastoris being particularly rich in niacin and riboflavin. Additionally, Pichia pastoris is very low in sugar, with sugar content around 4% by weight for glycerol-fed Pichia pastoris, and this level may be further reduced to undetectable amounts when fed with methanol. In at least one embodiment, the yeast component or extract thereof (e.g., Pichia pastoris) has a sugar content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture. In at least one embodiment, the yeast component or extract thereof (e.g., Pichia pastoris) has a sugar content of (excluding moisture) about 0.5% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, or within any range defined by and inclusive of any of these values (e.g., from about 1% by weight to about 10% by weight).

[0049] Pichia pastoris also has a low fat content, ranging from approximately 3.5% to 4% by weight, with the majority of this fat consisting of monounsaturated and polyunsaturated fats. In at least one embodiment, the yeast component or extract thereof (e.g., Pichia pastoris) has a total fat content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1% or more than about 1% excluding moisture. In at least one embodiment, the yeast component or extract thereof (e.g., Pichia pastoris) has a total fat content of (excluding moisture) about 0.5% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, or within any range defined by and inclusive of any of these values (e.g., from about 1% by weight to about 5% by weight).

[0050] In at least one embodiment, the total fat content of the yeast component (e.g., Pichia pastoris) has a monounsaturated fat content of (based on total fat content) about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41%, about 42%, about 43%, about44%, about 45%, about 46%, about 47%, about 48%, about 49%, about 50%, about 51%, about52%, about 53%, about 54%, about 55%, about 56%, about 57%, about 58%, about 59%, about60%, about 61%, about 62%, about 63%, about 64%, about 65%, or within any range defined by and inclusive of any of these values (e.g., from about 40% to about 60%).

[0051] In at least one embodiment, the total fat content of the yeast component (e.g., Pichia pastoris) has a polyunsaturated fat content of (based on total fat content) about 15%, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%,Docket No. 38592-15 about 33%, about 34%, about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, or within any range defined by and inclusive of any of these values (e.g., from about 25% to about 40%).

[0052] In at least one embodiment, the yeast component (e.g., Pichia pastoris) has a fiber content of (excluding moisture) about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, about 35%, or within any range defined by and inclusive of any of these values (e.g., from about 10% to about 30%).

[0053] The following exemplary embodiments are now described.

[0054] Embodiment 1 : A nutritional composition comprising a dried yeast component or extract thereof and optionally one or more additives, wherein the dried yeast component or extract thereof is incorporated into the nutritional composition in the form of a powder.

[0055] Embodiment 2: The nutritional composition of Embodiment 1, wherein the nutritional composition is in the form of a powder, an encapsulated powder, a tablet, a granule, a pellet, or a bar.

[0056] Embodiment 3 : The nutritional composition of either Embodiment 1 or Embodiment 2, wherein the dried yeast component or extract thereof comprises one or more of Pichia pastoris, Saccharomyces cerevisiae, Saccharomyces boulardii, Kluyveromyces marxianus, Candida ulilis, Hansenula polymorpha, Yarrowia lipolylica, or combinations thereof.

[0057] Embodiment 4: The nutritional composition of any one of the preceding Embodiments, wherein the dried yeast component or extract thereof comprises Pichia pastoris.

[0058] Embodiment 5 : The nutritional composition of any one of the preceding Embodiments, wherein a total protein content of the dried yeast component or extract thereof is greater than about 45% by weight excluding moisture and optionally up to or up to about 75% by weight excluding moisture.

[0059] Embodiment 6: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a total protein content greater than about 62% by weight excluding moisture.

[0060] Embodiment 7 : The nutritional composition of any one of the precedingEmbodiments, the dried yeast component or extract thereof having a complete amino acid composition.

[0061] Embodiment 8: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a beta glucan content greaterDocket No. 38592-15 than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture.

[0062] Embodiment 9: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a beta glucan content greater than about 7% by weight excluding moisture.

[0063] Embodiment 10: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a beta glucan content greater than about 10% by weight excluding moisture.

[0064] Embodiment 11 : The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a moisture content of less than about 15% and optionally more than about 0.001%, more than about 0.01%, or more than about 0.1%.

[0065] Embodiment 12: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a moisture content of less than about 10%.

[0066] Embodiment 13: The nutritional composition of any one of the preceding Embodiments, wherein dried yeast component or extract thereof is dried via drum drying or spray drying.

[0067] Embodiment 14: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a mean particle diameter of less than about 1000 pm and optionally more than about 10 pm, about 50 pm, or about 75 pm to about 100 pm.

[0068] Embodiment 15: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a mean particle diameter of less than about 600 pm.

[0069] Embodiment 16: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a mean particle diameter of less than about 300 pm.

[0070] Embodiment 17: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a mean particle diameter of less than about 150 pm.

[0071] Embodiment 18: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having an angle of repose of less than 40°.Docket No. 38592-15

[0072] Embodiment 19: The nutritional composition of any one of the preceding Embodiments, wherein 100% of the dried yeast component in powder form is passable through 14 mesh and at least about 50% of the dried yeast in powder form passes through 30 mesh.

[0073] Embodiment 20: The nutritional composition of any one of the preceding Embodiments, the dried yeast component or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0074] Embodiment 21: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise a microorganism.

[0075] Embodiment 22: The nutritional composition of Embodiment 21, wherein the microorganism comprises a microalgae or cyanobacteria.

[0076] Embodiment 23: The nutritional composition of Embodiment 22, wherein the microalgae or cyanobacterial comprisings spirulina, Arthrospira platensis, Arthospira fusiformis, Arthrospira maxima, Chlorella vulgaris, tetraselmis, isochrysis, nanochloropsis, or a combination thereof.

[0077] Embodiment 24: The nutritional composition of Embodiment 21, wherein the microorganism comprises Baker’s yeast, Brewer’ s yeast, Saccharomyces cerevisiae, Saccharomyces boulardii, Torula yeast, Candida utilis, Yarrowia lipolytica, Cenovis, or a combination thereof.

[0078] Embodiment 25: The nutritional composition of Embodiment 21, wherein the microorganism comprises probiotic bacteria.

[0079] Embodiment 26: The nutritional composition of Embodiment 25, wherein the probiotic bacteria comprises Lactobacillus acidophilus, Lactobacillus ramnosis, Lactobacillus paracasei, Lactobacillus plantarum, Bifidobacterium bifidum, Bifidobacterium lactis, Lactococcus lactis, or a combination thereof.

[0080] Embodiment 27: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise a flavoring composition.

[0081] Embodiment 28: The nutritional composition of Embodiment 27, wherein the flavoring composition comprises chocolate, vanilla, hazelnut, peanut, almond, coconut, banana, strawberry, blueberry, watermelon, mint, stevia extract, or a combination thereof.

[0082] Embodiment 29: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise binders, desiccants, flow additives, silicon dioxide, magnesium stearate, talc, or a combination thereof.Docket No. 38592-15

[0083] Embodiment 30: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise a dried protein concentrate.

[0084] Embodiment 31 : The nutritional composition of Embodiment 30, wherein the dried protein concentrate comprises whey protein, soy protein isolate, pea protein, or a combination thereof.

[0085] Embodiment 32: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additive comprises a powder or extract thereof of dried plant, herb, root, mushroom, berry, groundnut, nut, seed, or a combination thereof.

[0086] Embodiment 33 : The nutritional composition of Embodiment 32, wherein the powder or extract thereof comprises cocoa, vanilla, acai berry, banana, blueberry, blueberry skin, chia seed, pumpkin seed, peanut, almond, walnut, hazelnut, pistachio, basil, garlic, coconut, kale, flax seed, hemp seed, butternut squash seed, sesame seed, sunflower seed, pomegranate seed, pine nuts, quinoa, coffee, kola nut, beet powder, rhodiola rosea, bacopa monnieri, ginseng, ginkgo biloba, saw palmetto, lion’s mane mushroom, reishi mushroom, turkey tail, cordyceps militaris, ashwagandha root, tribulus terrestrius, safed musli root, maca root, shilagit root, black pepper extract, moringa leaf, alfalfa, or a combination thereof.

[0087] Embodiment 34: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise collagen powder or collagen peptides.

[0088] Embodiment 35: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise caffeine, thiamin, riboflavin, niacin, pantothenic acid, pyroxine, biotin, folate, cyanobalamin, vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, calcium salts, powdered eggshells, magnesium salts, zinc salts, potassium salts, iron salts, phosphorous salts, selenium salts, beta glucan, cellulose, creatine phosphate, or a combination thereof.

[0089] Embodiment 36: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise essential amino acids, L-citrulline, L-arginine, L-ornithine, methionine, tryptophan, threonine, histidine, lysine, leucine, valine, phenylalanine, or a combination thereof.

[0090] Embodiment 37: The nutritional composition of any one of the preceding Embodiments, wherein the dried yeast component or extract thereof comprises Pichia pasloris. wherein the Pichia pastoris has a sugar content less than about 10% by weight excludingDocket No. 38592-15 moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture.

[0091] Embodiment 38: The nutritional composition of Embodiment 37, wherein the Pichia pastoris has a sugar content less than about 7% by weight excluding moisture.

[0092] Embodiment 39: The nutritional composition of Embodiment 37, wherein the Pichia pastoris has a sugar content less than about 5% by weight excluding moisture.

[0093] Embodiment 40: The nutritional composition of Embodiment 37, wherein the Pichia pastoris has a sugar content less than about 2% by weight excluding moisture.

[0094] Embodiment 41 : The nutritional composition of Embodiment 37, wherein the Pichia pastoris has a fiber content of about 10% to about 30% by weight excluding moisture.

[0095] Embodiment 42: The nutritional composition of any one of the preceding Embodiments, wherein the dried yeast component or extract thereof comprises Pichia pastoris, wherein the Pichia pastoris has a total fat content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1% or more than about 1% excluding moisture.

[0096] Embodiment 43: The nutritional composition of Embodiment 42, wherein the Pichia pastoris has a total fat content less than about 7% by weight excluding moisture.

[0097] Embodiment 44: The nutritional composition of Embodiment 42, wherein the Pichia pastoris has a total fat content less than about 5% by weight excluding moisture.

[0098] Embodiment 45: The nutritional composition of Embodiment 42, wherein the Pichia pastoris has a total fat content less than about 2% by weight excluding moisture.

[0099] Embodiment 46: The nutritional composition of Embodiment 42, wherein the total fat content comprises about 35% to about 65% by weight of monounsaturated fats and about 15% to 40% by weight of polyunsaturated fats.

[0100] Embodiment 47: The nutritional composition of any one of the preceding Embodiments, wherein the nutritional composition is formulated into a liquid.

[0101] Embodiment 48: The nutritional composition of Embodiment 47, wherein the liquid comprises water, milk, oat milk, soy milk, almond milk, fruit juices, coffee, or tea.

[0102] Embodiment 49: The nutritional composition of any one of the preceding Embodiments, comprising the one or more additives, wherein the one or more additives comprise yogurt, nut powders, peanut powder, almond powder, algae powder, spirulina algae, collagen powder, collagen peptide, kale, spinach, beet, acai berry, blueberry, banana, or a combination thereof.

[0103] Embodiment 50: A nutritional composition comprising dried yeast component or extract thereof and optionally one or more additives, wherein the dried yeast component orDocket No. 38592-15 extract thereof is incorporated into the nutritional composition in the form of a powder, the dried yeast component or extract thereof having an angle of repose of less than 40°.

[0104] Embodiment 51 : A nutritional composition comprising dried yeast component or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0105] Embodiment 52: A nutritional composition comprising dried Pichia pastoris yeast or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0106] Embodiment 53: A nutritional composition comprising a powder comprising: Pichia pastoris or extract thereof; Chlorella vulgaris or extract thereof; spirulina; alfalfa leaf; moringa leaf; and a fruit blend, wherein a beta glucan content of the Pichia pastoris or extract thereof is from about 5% to about 20% by weight.

[0107] Embodiment 54: Dried Pichia pastoris or an extract thereof having: a protein content of about 45% to about 70% by weight excluding moisture, preferably greater than about 55% by weight excluding moisture; a beta glucan content greater than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture; a sugar content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture; a fiber content of about 10% to about 30% by weight excluding moisture; a total fat content less than about 7% by weight excluding moisture, wherein the total fat content comprises about 35% to about 65% by weight of monounsaturated fats and about 15% to 40% by weight of polyunsaturated fats; or a combination thereof.

[0108] Embodiment 55: A method of forming a powder comprising Pichia pastoris or extract thereof, the method comprising: spray-drying the Pichia pastoris or extract thereof to form the powder.

[0109] Embodiment 56: The method of Embodiment 55, wherein the powder has a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

[0110] Embodiment 57: The method of either Embodiment 55 or Embodiment 56, wherein the powder has an angle of repose of less than 40°.[oni] Embodiment 58: The method of any one of Embodiments 55-57, further comprising: pretreating the Pichia pastoris via one or more of thermal shock treatment, high-pressure cell disruption, or slow pasteurization.

[0112] Embodiment 59: A nutritional blend comprising: a dried yeast component or extract thereof of Pichia pastoris present from about 50% by weight to about 90% by weight excludingDocket No. 38592-15 moisture; and a fruit or vegetable blend present from about 10% by weight to about 50% by weight excluding moisture.

[0113] Embodiment 60: A method of forming a beverage comprising adding the nutritional composition of any one of Embodiments 1-53, the Pichia pastoris or an extract thereof of Embodiments 54-58, or the nutritional blend of Embodiment 59 to a liquid.

[0114] Embodiment 61 : A method of providing nutritional benefit to a patient in need thereof comprising administering the nutritional composition of any of nutritional composition of any one of Embodiments 1-53, the Pichia pastoris or an extract thereof of Embodiments 54-58, or the nutritional blend of Embodiment 59 to a liquid to the patient.

[0115] Embodiment 62: A method of treating malnutrition and to an underweight patient in need thereof comprising administering the nutritional composition of any one of Embodiments 1-53, the Pichia pastoris or an extract thereof of Embodiments 54-58, or the nutritional blend of Embodiment 59 to a liquid to the patient.ILLUSTRATIVE EXAMPLES

[0116] The following examples are set forth to assist in understanding the disclosure and should not be construed as specifically limiting the invention described and claimed herein. Such variations of the invention, including the substitution of all equivalents now known or later developed, which would be within the purview of those skilled in the art, and changes in formulation or minor changes in experimental design, are to be considered to fall within the scope of the invention incorporated herein.Example 1: Fermentation of Pichia pastoris

[0117] The Komagatella phaffh (Pichia pastoris) BSYBG10 strain provided by bisy GmbH (Hofstatten an der Raab, Austria) is used. The fermentation procedure is described as follows.

[0118] First, a working cell bank (WCW) was stored at -80°C / -112°F and then introduced into 1 L shake flasks, each filled with 150 mL of YPG medium. The YPG medium contained, per liter of distilled water: 20 g glycerol, 20 g peptone, and 10 g yeast extract.

[0119] A fed-batch composition contained, per liter of distilled water: 1.8 g citric acid, 40 g glycerol, 12.6 g (NH4)2HPO4, 0.5 g MgSO47H2O, 0.9 g KC1, 0.02 g CaCl22H2O, 0.05 ml antifoam Glanapon 2000kz, 0.4 mg biotin, and 4.6 ml trace salts solution. The trace salts solution contained, per liter: 6.0 g CuSO45H2O, 0.08 g Nal, 3.36 g MnSO4H2O, 0.2 g Na2MoO42H2O, 0.02 g H3BO3, 0.82 g CoCl2, 20.0 g ZnCl2, 65.0 g FeSO47H2O, and 5.0 ml H2SO4(98%).Docket No. 38592-15

[0120] Temperature was maintained at 32°C, dissolved oxygen was maintained above >30%, and pH was maintained at 6 for all conditions with the addition of 15% NH4OH.Example 2: Pretreatment Protocols

[0121] The following different pre-treatments were tested and implemented.

[0122] Thermal Shock treatment: 100 mL concentrated biomass at approximately 100 g / L was heat-treated at 55°C (131°F) for 16 hours at 180 rpm in a shaker incubator.

[0123] High-Pressure Cell Disruption: 100 mL concentrated biomass at approximately 100 g / L was mechanically disrupted using a one-shot cell disruptor (Constant Systems, Daventry, UK) at 4°C (39.2°F). Two kbars and up to three passes were selected as the optimal working pressure.

[0124] Slow Pasteurization: 100 mL concentrated biomass at approximately 100 g / L was subjected to slow pasteurization by passing the sample at 1 mL / min through a 30 cm holding tube immersed in a thermal bath at 65°C (149°F), corresponding to 30 minutes of heat treatment, and then immediately placed in an ice-water bath.Example 3: Spray-Drying

[0125] Untreated or treated biomass was subjected to spray drying using a Mini Spray Dryer B-290 (Buchi, Switzerland) under the following conditions: inlet temperature of 120, 140, or 160 °C (248, 284, or 320 °F), air flow rate of 50 L / min, aspirator set to 90%, pump set to 10% (120 mL / h), and nozzle cleaner engaged.Example 4: Characterization of Samples

[0126] Total protein content was determined by measuring nitrogen using the Dumas method (FP828, Leco, St. Joseph, USA) and calculating crude protein with a conversion factor of 6.25 (Leco Application Note: Determination of nitrogen / protein in flour. LECO Corporation, Saint Joseph, MI, USA).

[0127] Moisture content was determined by measuring the loss in weight of the sample after heating at 105 °C in a convection oven for 24 hours.

[0128] To perform amino acid profiling, the dried samples were subjected to digestion in a microwave-assisted digestion system (Ethos One, Milestone Sri, Sorisole, Italy) at 170 °C for 15 min with 6 M hydrochloric acid. For tryptophan analysis, digestion was performed with 5 M sodium hydroxide for 40 min at 170 °C. Following digestion, the samples were diluted in 0.1 M hydrochloric acid or water (the latter for tryptophan determination) and analyzed by HPLC- DAD-FLD (1100 series, Agilent Technologies, Santa Clara, CA, USA), based on the methodDocket No. 38592-15 outlined by Willmann (2024). Separation was conducted using a Zorbax Eclipse AAA column 4.6 x 150 mm, 3.5 pm (Agilent Technologies) at 40 °C. The mobile phase consisted of 10 mM sodium hydrogen phosphate and 10 mM sodium tetraborate buffer (pH 8.2) as phase A, while phase B comprised a mixture of acetonitrile / methanol / water (45:45: 10 v / v / v). Samples were derivatized with o-phthalaldehyde and 9-fluorenylmethyl chloroformate (Agilent Technologies) using an automated vial sampler (1260 Infinity II, Agilent Technologies). Peak identification was performed by comparing retention time and spectral information with pure standard solutions (Agilent P / N 5061-3330, Agilent Technologies Inc., Santa Clara, CA, USA). Quantification was carried out using internal standards (norvaline and sarcosine) by fluorescence detection at 345 / 455 nm (excitation / emission), except for proline, which was quantified by fluorescence at 265 / 315 nm, and cysteine, by diode-array at 338 nm (Agilent Series 1200;Agilent Technologies Inc., Santa Clara, CA, USA).

[0129] The amino acid profiles of various Pichia pastoris yeast samples is shown in FIG. 1. Different feeding conditions included 100% MeOH feeding, 70% MeOH and 30% glycerol feeding, and 100% glycerol feeding.

[0130] Nutritional content for glycerol-fed Pichia pastoris is shown in Tables 3 and 4, and nutritional content for methanol-fed Pichia pastoris is shown in Tables 5 and 6. Beta glucan content was determined using a beta glucan assay (Megazyme, K-YBGL). Riboflavin content was determined by Microbiological Method B2FV S. Vitamin B12 content was determined by Microbiological Method B12F S. Water soluble vitamin content (thiamin, niacin, pyridoxine, and biotin) was determined by LC-MS / MS (BLCMS_S).Table 3 : Nutritional content for glycerol-fed Pichia pastorisDocket No. 38592-15Table 4: Beta glucan and vitamin content for glycerol-fed Pichia pastorisTable 5: Nutritional content for methanol-fed Pichia pastorisDocket No. 38592-15Table 6: Beta glucan and vitamin content for methanol-fed Pichia pastorisExample 5: In vitro protein digestibility (IVPD)

[0131] In vitro protein digestibility (IVPD) was assessed using the multienzyme method described by Hsu et al. (1977). The sample was dispersed in 10 mL ultrapure water (6.25 mg protein / mL) and adjusted to pH 8.0 at 37 °C in a water bath. Then, 1.0 mL of enzyme mix solution (also at pH 8.0, 37 °C) was added, containing trypsin from porcine pancreas (2,112 U / mL; TCI Chemical Trading Co, Tokyo, Japan), a-chymotrypsin from bovine pancreas (18 U / mL; Sigma-Aldrich, Darmstadt, Germany), and pepsin from porcine gastric mucosa (4.57 U / mL; Sigma-Aldrich, Darmstadt, Germany). P-casein was used as a control sample. The pH drop was recorded after 10 minutes, and IVPD (%) was calculated as: IVPD (%) = 210.46 - 18.10 x (pH at 10 min).

[0132] In the foregoing description, numerous specific details are set forth, such as specific materials, dimensions, processes parameters, etc., to provide a thorough understanding of the embodiments of the present disclosure. The particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. The words “example” or “exemplary” are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as an “example” or “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the words “example” or “exemplary” is intended to present concepts in a concrete fashion.Docket No. 38592-15As used in this application, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless specified otherwise, or clear from context, “X includes A or B” is intended to mean any of the natural inclusive permutations. That is, if X includes A; X includes B; or X includes both A and B, then “X includes A or B” is satisfied under any of the foregoing instances. In addition, the use of the terms “a,” “an,” “the,” and similar referents in the context of describing the materials and methods discussed herein (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context.

[0133] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

[0134] Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments,” “an embodiment,” or “some embodiments” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment,” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0135] It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to illuminate certain materials and methods and does not pose a limitation on scope. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosed materials and methods.

[0136] Although the embodiments disclosed herein have been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of theDocket No. 38592-15 present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents, and the above-described embodiments are presented for the purposes of illustration and not of limitation.

Claims

Docket No. 38592-15What is claimed is:

1. A nutritional composition comprising a dried yeast component or extract thereof and optionally one or more additives, wherein the dried yeast component or extract thereof is incorporated into the nutritional composition in the form of a powder.

2. The nutritional composition of claim 1, wherein the nutritional composition is in the form of a powder, an encapsulated powder, a tablet, a granule, a pellet, or a bar.

3. The nutritional composition of claim 1, wherein the dried yeast component or extract thereof comprises one or more of Pichia pasloris. Saccharomyces cerevisiae. Saccharomyces boulardii, Kluyveromyces marxianus. Candida ulilis. Hansenula polymorpha, Yarrowia lipolylica. or combinations thereof.

4. The nutritional composition of claim 1, wherein the dried yeast component or extract thereof comprises Pichia pastoris.

5. The nutritional composition of claim 1, wherein a total protein content of the dried yeast component or extract thereof is greater than about 45% by weight excluding moisture and optionally up to or up to about 75% by weight excluding moisture.

6. The nutritional composition of claim 1, the dried yeast component or extract thereof having a total protein content greater than about 62% by weight excluding moisture.

7. The nutritional composition of claim 1, the dried yeast component or extract thereof having a complete amino acid composition.

8. The nutritional composition of claim 1, the dried yeast component or extract thereof having a beta glucan content greater than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture.

9. The nutritional composition of claim 1, the dried yeast component or extract thereof having a beta glucan content greater than about 7% by weight excluding moisture.Docket No. 38592-1510. The nutritional composition of claim 1, the dried yeast component or extract thereof having a beta glucan content greater than about 10% by weight excluding moisture.

11. The nutritional composition of claim 1, the dried yeast component or extract thereof having a moisture content of less than about 15% and optionally more than about 0.001%, more than about 0.01%, or more than about 0.1%.

12. The nutritional composition of claim 1, the dried yeast component or extract thereof having a moisture content of less than about 10%.

13. The nutritional composition of claim 1, wherein dried yeast component or extract thereof is dried via drum drying or spray drying.

14. The nutritional composition of claim 1, the dried yeast component or extract thereof having a mean particle diameter of less than about 1000 pm and optionally more than about 10 pm, about 50 pm, or about 75 pm to about 100 pm.

15. The nutritional composition of claim 1, the dried yeast component or extract thereof having a mean particle diameter of less than about 600 pm.

16. The nutritional composition of claim 1, the dried yeast component or extract thereof having a mean particle diameter of less than about 300 pm.

17. The nutritional composition of claim 1, the dried yeast component or extract thereof having a mean particle diameter of less than about 150 pm.

18. The nutritional composition of claim 1, the dried yeast component or extract thereof having an angle of repose of less than 40°.

19. The nutritional composition of claim 1, wherein 100% of the dried yeast component in powder form is passable through 14 mesh and at least about 50% of the dried yeast in powder form passes through 30 mesh.

20. The nutritional composition of claim 1, the dried yeast component or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.Docket No. 38592-1521. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise a microorganism.

22. The nutritional composition of claim 21, wherein the microorganism comprises a microalgae or cyanobacteria.

23. The nutritional composition of claim 22, wherein the microalgae or cyanobacterial comprisings spirulina, Arthrospira platensis, Arthospira fusiformis, Arthrospira maxima, Chlorella vulgaris, tetraselmis, isochrysis, nanochloropsis, or a combination thereof.

24. The nutritional composition of claim 21, wherein the microorganism comprises Baker’s yeast, Brewer’s yeast, Saccharomyces cerevisiae, Saccharomyces boulardii, Torula yeast, Candida utilis, Yarrowia lipolytica, Cenovis, or a combination thereof.

25. The nutritional composition of claim 22, wherein the microorganism comprises probiotic bacteria.

26. The nutritional composition of claim 25, wherein the probiotic bacteria comprises Lactobacillus acidophilus, Lactobacillus ramnosis, Lactobacillus paracasei, Lactobacillus plantarum, Bifidobacterium bifidum, Bifidobacterium lactis, Lactococcus lactis, or a combination thereof.

27. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise a flavoring composition.

28. The nutritional composition of claim 27, wherein the flavoring composition comprises chocolate, vanilla, hazelnut, peanut, almond, coconut, banana, strawberry, blueberry, watermelon, mint, stevia extract, or a combination thereof.

29. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise binders, desiccants, flow additives, silicon dioxide, magnesium stearate, talc, or a combination thereof.Docket No. 38592-1530. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise a dried protein concentrate.

31. The nutritional composition of claim 30, wherein the dried protein concentrate comprises whey protein, soy protein isolate, pea protein, or a combination thereof.

32. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additive comprises a powder or extract thereof of dried plant, herb, root, mushroom, berry, groundnut, nut, seed, or a combination thereof.

33. The nutritional composition of claim 32, wherein the powder or extract thereof comprises cocoa, vanilla, acai berry, banana, blueberry, blueberry skin, chia seed, pumpkin seed, peanut, almond, walnut, hazelnut, pistachio, basil, garlic, coconut, kale, flax seed, hemp seed, butternut squash seed, sesame seed, sunflower seed, pomegranate seed, pine nuts, quinoa, coffee, kola nut, beet powder, rhodiola rosea, bacopa monnieri, ginseng, ginkgo biloba, saw palmetto, lion’s mane mushroom, reishi mushroom, turkey tail, cordyceps militaris, ashwagandha root, tribulus terrestrius, safed musli root, maca root, shilagit root, black pepper extract, moringa leaf, alfalfa, or a combination thereof.

34. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise collagen powder or collagen peptides.

35. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise caffeine, thiamin, riboflavin, niacin, pantothenic acid, pyroxine, biotin, folate, cyanobalamin, vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, calcium salts, powdered eggshells, magnesium salts, zinc salts, potassium salts, iron salts, phosphorous salts, selenium salts, beta glucan, cellulose, creatine phosphate, or a combination thereof.

36. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise essential amino acids, L-citrulline, L-arginine, L-ornithine, methionine, tryptophan, threonine, histidine, lysine, leucine, valine, phenylalanine, or a combination thereof.Docket No. 38592-1537. The nutritional composition of claim 1, wherein the dried yeast component or extract thereof comprises Pichia pastoris, wherein the Pichia pastoris has a sugar content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture.

38. The nutritional composition of claim 37, wherein the Pichia pastoris has a sugar content less than about 7% by weight excluding moisture.

39. The nutritional composition of claim 37, wherein the Pichia pastoris has a sugar content less than about 5% by weight excluding moisture.

40. The nutritional composition of claim 37, wherein the Pichia pastoris has a sugar content less than about 2% by weight excluding moisture.

41. The nutritional composition of claim 37, wherein the Pichia pastoris has a fiber content of about 10% to about 30% by weight excluding moisture.

42. The nutritional composition of claim 1, wherein the dried yeast component or extract thereof comprises Pichia pastoris, wherein the Pichia pastoris has a total fat content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1% or more than about 1% excluding moisture.

43. The nutritional composition of claim 42, wherein the Pichia pastoris has a total fat content less than about 7% by weight excluding moisture.

44. The nutritional composition of claim 42, wherein the Pichia pastoris has a total fat content less than about 5% by weight excluding moisture.

45. The nutritional composition of claim 42, wherein the Pichia pastoris has a total fat content less than about 2% by weight excluding moisture.

46. The nutritional composition of claim 42, wherein the total fat content comprises about 35% to about 65% by weight of monounsaturated fats and about 15% to 40% by weight of polyunsaturated fats.Docket No. 38592-1547. The nutritional composition of claim 1, wherein the nutritional composition is formulated into a liquid.

48. The nutritional composition of claim 47, wherein the liquid comprises water, milk, oat milk, soy milk, almond milk, fruit juices, coffee, or tea.

49. The nutritional composition of claim 1, comprising the one or more additives, wherein the one or more additives comprise yogurt, nut powders, peanut powder, almond powder, algae powder, spirulina algae, collagen powder, collagen peptide, kale, spinach, beet, acai berry, blueberry, banana, or a combination thereof.

50. A nutritional composition comprising dried yeast component or extract thereof and optionally one or more additives, wherein the dried yeast component or extract thereof is incorporated into the nutritional composition in the form of a powder, the dried yeast component or extract thereof having an angle of repose of less than 40°.

51. A nutritional composition comprising dried yeast component or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

52. A nutritional composition comprising dried Pichia pastoris yeast or extract thereof having a cell viability of less than about 5 x 105colony forming units (CFU) per gram.

53. A nutritional composition comprising a powder comprising:Pichia pastoris or extract thereof;Chlorella vulgaris or extract thereof; spirulina; alfalfa leaf; moringa leaf; and a fruit blend, wherein a beta glucan content of the Pichia pastoris or extract thereof is from about 5% to about 20% by weight.

54. Dried Pichia pastoris or an extract thereof having: a protein content of about 45% to about 70% by weight excluding moisture, preferably greater than about 55% by weight excluding moisture;Docket No. 38592-15 a beta glucan content greater than about 5% by weight excluding moisture and optionally up to about 50%, up to about 35%, or up to about 20% by weight excluding moisture; a sugar content less than about 10% by weight excluding moisture and optionally more than about 0.001%, more than about 0.01%, more than about 0.1%, or more than about 1% by weight excluding moisture; a fiber content of about 10% to about 30% by weight excluding moisture; a total fat content less than about 7% by weight excluding moisture, wherein the total fat content comprises about 35% to about 65% by weight of monounsaturated fats and about 15% to 40% by weight of polyunsaturated fats; or a combination thereof.

55. A method of forming a powder comprising Pichia pastoris or extract thereof, the method comprising: spray-drying the Pichia pastoris or extract thereof to form the powder.

56. The method of claim 55, wherein the powder has a cell viability of less than about5 x 105colony forming units (CFU) per gram.

57. The method of claim 55, wherein the powder has an angle of repose of less than 40°.

58. The method of claim 55, further comprising: pretreating the Pichia pastoris via one or more of thermal shock treatment, high-pressure cell disruption, or slow pasteurization.

59. A nutritional blend comprising: a dried yeast component or extract thereof of Pichia pastoris present from about 50% by weight to about 90% by weight excluding moisture; and a fruit or vegetable blend present from about 10% by weight to about 50% by weight excluding moisture.

60. A method of forming a beverage comprising adding the nutritional composition of any one of claims 1-53 or the nutritional blend of claim 59 to a liquid.Docket No. 38592-1561. A method of providing nutritional benefit to a patient in need thereof comprising administering the nutritional composition of any of claims 1-53 or the nutritional blend of claim 59 to the patient.

62. A method of treating malnutrition and to an underweight patient in need thereof comprising administering the nutritional composition of any of claims 1-53 or the nutritional blend of claim 59 to the patient.

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