Purified Animal Colostrum Nutritional Supplement

Abstract

Provided is a method of optimizing animal colostrum for human consumption by removing allergenic components and combining one or more immune factors to enable the composition to target the mucosal barriers, thereby enhancing mucosal integrity and increasing immune support. The composition is purified to remove one or more of lactose, casein proteins, fats, and/or oils, thereby creating a product that is devoid of allergenic components. The composition may be combined with a prebiotic, and/or natural sweeteners, additional vitamins, herbs, and/or minerals, and flavoring ingredients. The resulting product forms an instantly dissolvable powder that can be distributed in single serve packets, aerosolized spray, and/or in a chewable form. Furthermore, the composition can be used as an ingredient in food and beverages, in infant formula, in medical foods, or in over-the-counter drugs. Also provided is a method of manufacturing the bioactive composition.

Claims

1. A method of optimizing animal colostrum for human consumption, comprising: removing allergenic components comprising one or more of lactose, casein proteins, fats, and oils, and combining immune factors to formulate a composition comprising bioactive peptides including PrP, IgG, IgA, protein, fat, moisture, ash, milk oligosaccharides, IgM, Lactoperoxidase, Alpha-Lactalbumin, sIgA, Lactoferrin, Beta-lactoglobulin, Animal Serum Albumin, milk minerals, growth factors and minor components, and sialic acid, wherein said optimized composition targets the mucosal barrier.

2. The method of claim 1, wherein said composition comprises PrP in the range of 0-40%, IgG in the range of 0-60%, IgA in the range of 0-40%, protein in the range of 0-40%, fat in the range of 0-40%, moisture in the range of 0-10%, ash in the range of 0-40%, milk oligosaccharides in the range of 0-40%, IgM in the range of 0-40%, Lactoperoxidase in the range of 0-40%, Alpha-Lactalbumin in the range of 0-40%, moisture in the range of 0-10%, sIgA in the range of 0-40%, Lactoferrin in the range of 0-40%, Beta-lactoglobulin in the range of 0-40%, Animal Serum Albumin in the range of 0-40%, milk minerals in the range of 0-40%, and growth factors and minor components in the range of 0-40%.

3. The method of claim 1, wherein said composition comprises PrP at a concentration of 8.40%, IgG at a concentration of 37.35%, IgM at a concentration of 3.27%, Lactoperoxidase at a concentration of 0.19%, Alpha-Lactalbumin at a concentration of 6.72%, sIgA at a concentration of 4.20%, Lactoferrin at a concentration of 0.37%, Beta-lactoglobulin at a concentration of 14.01%, Animal Serum Albumin at a concentration of 2.43%, milk minerals at a concentration of 14.57%, growth factors and minor components at a concentration of 1.03%, and milk oligosaccharides at a concentration of 1.00%.

4. The method of claim 1, wherein said composition is combined with a prebiotic, and/or natural sweeteners, additional vitamins, herbs, and/or minerals, and flavoring ingredients.

5. The method of claim 1, wherein said composition comprises an instantly dissolvable powder that can be distributed in single serve packets, and/or in a chewable form.

6. The method of claim 1, wherein said composition comprises an ingredient in food and beverages, in infant formula, in medical foods, or in over-the-counter drugs.

7. A method of optimizing animal colostrum for human consumption, comprising: removing allergenic components comprising one or more of lactose, casein proteins, fats, and oils, and combining immune factors, wherein said optimized composition targets the mucosal barrier.

8. The method of claim 7, wherein said immune factors comprise IgG, IgA, protein, fat, moisture, ash, and oligosaccharide containing carbohydrates.

9. The method of claim 7, wherein said immune factors comprise IgG at a concentration of 32%, IgA at a concentration of 2%, protein at a concentration of 64%, fat at a concentration of 2%, moisture at a concentration of 4.8%, ash at a concentration of 5.5%, and oligosaccharide containing carbohydrates at a concentration of 24%.

10. The method of claim 7, wherein said composition comprises PrP at a concentration of 8.40%, IgG at a concentration of 37.35%, IgM at a concentration of 3.27%, Lactoperoxidase at a concentration of 0.19%, Alpha-Lactalbumin at a concentration of 6.72%, sIgA at a concentration of 4.20%, Lactoferrin at a concentration of 0.37%, Beta-lactoglobulin at a concentration of 14.01%, Animal Serum Albumin at a concentration of 2.43%, milk minerals at a concentration of 14.57%, growth factors and minor components at a concentration of 1.03%, and milk oligosaccharides at a concentration of 1.00%.

11. The method of claim 7, wherein said composition is combined with a prebiotic, and/or natural sweeteners, additional vitamins, herbs, and/or minerals, and flavoring ingredients.

12. The method of claim 7, wherein said composition comprises an instantly dissolvable powder that can be distributed in single serve packets, and/or in a chewable form.

13. The method of claim 7, wherein said composition comprises an ingredient in food and beverages, in infant formula, in medical foods, or in over-the-counter drugs.

14. A method of optimizing animal colostrum for human consumption, comprising: removing allergenic components comprising one or more of lactose, casein proteins, fats, and oils, and combining immune factors comprising PrP in the range of 0-40%, IgG at a concentration of 32%, IgA at a concentration of 2%, protein at a concentration of 64%, fat at a concentration of 2%, moisture at a concentration of 4.8%, ash at a concentration of 5.5%, and oligosaccharide containing carbohydrates at a concentration of 24%, IgM in the range of 0-40%, Lactoperoxidase in the range of 0-40%, Alpha-Lactalbumin in the range of 0-40%, water in the range of 0-10%, Lactoferrin in the range of 0-40%, Beta-lactoglobulin in the range of 0-40%, Animal Serum Albumin in the range of 0-40%, milk minerals in the range of 0-40%, and growth factors and minor components in the range of 0-40%, wherein said optimized composition targets the mucosal barrier.

15. The method of claim 14, wherein said composition is combined with a prebiotic, and/or natural sweeteners, additional vitamins, herbs, and/or minerals, and flavoring ingredients.

16. The method of claim 14, wherein said composition comprises an instantly dissolvable powder that can be distributed in single serve packets, and/or in a chewable form.

17. The method of claim 14, wherein said composition comprises an ingredient in food and beverages, in infant formula, in medical foods, or in over-the-counter drugs.

Description

BRIEF DESCRIPTIONS OF THE DRAWINGS

[0026] Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself and manner in which it may be made and used may be better understood after a review of the following description, taken in connection with the accompanying drawings wherein like numeral annotations are provided throughout.

[0027] FIG. 1 shows the components of the purified composition.

[0028] FIG. 2 shows the components of the purified composition, their limits, and the method of assessment.

[0029] FIG. 3 shows the final test results related to the microbial purity of the final composition.

DETAILED DESCRIPTION OF THE INVENTION

[0030] Reference is made herein to the attached drawings. For the purposes of presenting a brief and clear description of the present invention, the preferred embodiment will be discussed as used as a supplement derived from animal colostrum for human consumption.

[0031] The methods and compositions of the present invention relate to an animal colostrum supplement that is optimized for human consumption. The composition is optimized in a twofold manner by removing allergenic components and by enhancing concentrations of one or more immune factors to enable the composition to target the mucosal barrier. The final product targets the human mucosal barrier, thereby enhancing mucosal integrity and increasing immune support. The composition prevents and/or treats conditions related to the disruption of the human mucosal barrier, including inflammation, allergic disease, infections and autoimmune conditions.

[0032] Many bioactive components found in colostrum are of particular importance to human health, and have been extensively studied. As a non-limiting example, secretory immunoglobulin A (SigA) confers passive immunity to newborn infants and is passed exclusively through human milk; predominantly, through colostrum. It is the predominant immunoglobulin present at mucosal surfaces. Research has demonstrated that bovine SigA is analogous to human SigA (Mach et al. Secretory IgA, a major immunoglobulin in most bovine external secretions, 1971. J. Immunol. 106:552-563), and elucidated its role in respiratory mucosal immunity, including excluding pathogen entry (Renegar et al. Role of IgA versus IgG in the control of influenza viral infection in the murine respiratory tract 2004, J. Immunol. 173, 1978-1986). SigA also plays a significant role in human mucosal immune defense by 1) excluding pathogens from making contact with epithelial cells; 2) trapping pathogens on the luminal surface via lectin binding; 3) cross-reacting with a broad range of pathogens; 4) does not activate complement efficiently; 5) is resistant to host and microbial proteases; and 6) maintains homeostasis of commensal bacteria required for follicle development (Mak et al. Mucosal and Cutaneous Immunity, The Immune Response 2006, Academic Press, 583-609).

[0033] Additionally, lactoferrin is a bioactive that plays an important role in human mucosal immunity by directly killing pathogens, inhibiting their binding and replication, and demonstrating an anti-inflammatory role. Lactoferrin also promotes barrier function at the mucosa. Several human studies have demonstrated lactoferrin's antiviral properties (van der Strate et al. Antiviral activities of lactoferrin 2001, Antiviral. Res. 52, 225-239), and ability to reduce the incidence of infections like sepsis, GI and respiratory disease in infants (Manzoni et al. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: A randomized Trial 2009, JAMA. 302:1421-1428; Ochoa et al. Clinical studies of lactoferrin in children 2012 Biochem. Cell Biol. 90:457-467; Manzoni et al. Bovine lactoferrin prevents invasive fungal infections in very low birth weight infants: A randomized controlled trial 2012, Pediatrics. 129:116-123).

[0034] Milk oligosaccharides are another important component in colostrum. Structurally, each oligosaccharide is built on a lactose backbone and is extended by the addition/combination of various molecules including galactose, fucose, sialic acid, and N-acetylglucosamine. Milk oligosaccharides pass largely intact to the colon where they serve as a prebiotic food source for the gut microbiome, thus encouraging populations of beneficial bacteria like bifidobacteria and lactobacilli. The benefit of milk oligosaccharides in human health include optimization of the intestinal microbiome, prevention of pathogen adhesion to the mucosa, antiviral activity, modulation of the intestinal epithelial cell response, and healthy immune system maturation (Wiciski et al. Human Milk Oligosaccharides: Health Benefits, Potential Applications in Infant Formulas, and Pharmacology 2020, Nutrients, 12(1), 266). Research suggests milk oligosaccharides have a role in reducing the incidence of various infections, allergies (Seppo et al. Human milk oligosaccharides and development of cow's milk allergy in infants 2017, J. Allergy Clin. Immunol. 139:708-11), auto-immune diseases, and inflammation (Vassilis et al. Immunological Effects of Human Milk Oligosaccharides 2018 Frontiers in Pediatrics 6:190).

[0035] The composition preferably includes a bioactive composition of animal colostrum processed via minimal heat pasteurization, followed by removal of one or more of lactose, casein protein, water, fats and oils from the raw material. The colostrum may be derived from any mammal, however, the present invention contemplates use of colostrum from bovine, porcine, ovine, human, or combinations thereof. In the preferred embodiment, the colostrum may be derived from bovine. As is well understood, colostrum is produced by mammals at the end of pregnancy and during the first 2-5 days postpartum. As compared to mature milk, colostrum contains elevated amounts of carbohydrates, including lactose, protein, and antibodies, which are in the form of immunoglobulins (IgA, IgD, IgG, IgE, and IgM). The total amount of immunoglobulins in natural bovine colostrum may be between 10-30% of the total protein content in colostrum, with IgG counting for up 85-90% of the total immunoglobulin content. As can be appreciated, the IgG concentration in bovine colostrum is much higher than that which is found in human colostrum. Proteins found in colostrum include casein, lactoferrin, lactalbumin, lactoglobulin, lactoperoxidase, proline rich polypeptides (PRPs) and growth factors, such as IGFs. Additionally, colostrum includes fat, vitamins, ash, milk oligosaccharides, minerals, and nutrients.

[0036] The colostrum can be collected by any method known in the art. Preferably, the colostrum is collected up to 24-72 hours postpartum. In some embodiments, lactose is removed, making the supplement optimal for consumption by lactose intolerant individuals. Alternately, the composition can be produced with lactose for use by individuals who are not sensitive to the sugar. With the removal of casein protein, water, fats/oil, and lactose, the final composition includes bioactive peptides, proteins, and oligosaccharides. In the preferred embodiment, the purified composition comprises the components listed in Table 1 and shown in FIG. 1.

TABLE-US-00001 TABLE 1 Components in the Composition Bioactive Peptides, including PrP IgG IgA Protein Fat Moisture Ash Milk Oligosaccharides IgM Lactoperoxidase Alpha-Lactalbumin sIgA Lactoferrin Beta-lactoglobulin Animal Serum Albumin Milk minerals Growth factors and minor components Sialic Acid

[0037] The components in the composition can be included in any percentage or w/w as desired. In the preferred embodiment, the composition includes Bioactive Peptides including PrP. In the preferred embodiment, the composition includes IgG. In the preferred embodiment, the composition includes IgA. In the preferred embodiment, the composition includes protein. In the preferred embodiment, the composition includes fat. In the preferred embodiment, the composition includes moisture. In the preferred embodiment, the composition includes Ash. In the preferred embodiment, the composition includes milk oligosaccharides. In the preferred embodiment, the composition includes IgM. In the preferred embodiment, the composition includes Lactoperoxidase. In the preferred embodiment, the composition includes Alpha-Lactalbumin. In the preferred embodiment, the composition includes water. In the preferred embodiment, the composition includes sIgA. In the preferred embodiment, the composition includes Lactoferrin. In the preferred embodiment, the composition includes Beta-lactoglobulin. In the preferred embodiment, the composition includes Animal Serum Albumin. In the preferred embodiment, the composition includes milk minerals. In the preferred embodiment, the composition includes growth factors and minor components. In the preferred embodiment, the composition includes sialic acid.

[0038] In one embodiment, the composition comprises the following components in the following amounts: IgG in the range of 0-40%, IgA in the range of 0-40%, protein in the range of 0-40%, fat in the range of 0-40%, moisture in the range of 0-40%, ash in the range of 0-40%, and oligosaccharide containing carbohydrates in the range of 0-40%. In another embodiment, the composition comprises the following components in the following amounts: IgG at a concentration of 30%, IgA at a concentration of 1.5%, protein at a concentration of 55%, fat at a concentration of 5%, moisture at a concentration of 5%, ash at a concentration of 10%, and oligosaccharide containing carbohydrates at a concentration of 30%.

[0039] In the preferred embodiment, the composition comprises the following components in the following amounts: IgG at a concentration of 32%, IgA at a concentration of 2%, protein at a concentration of 64%, fat at a concentration of 2%, moisture at a concentration of 4.8%, ash at a concentration of 5.5%, and oligosaccharide containing carbohydrates at a concentration of 24%.

[0040] The purified composition comprises the components and their percentages as listed in Table 2 and shown in FIG. 2.

TABLE-US-00002 TABLE 2 Preferred Components in the Composition and their Percentages Chemical Standards Limits Typical Method IgG 30% (Min) 32% HPLC/RID IgA 1.5% (Min) 2% RID Protein 55% (Min) 64% AOAC 992.15 Fat 5% (Min) 2% AOAC 932.06 Moisture 5% (Min) 4.8% AOAC 923.03 Ash 10% (Min) 5.5% SMEDP. 15.041 Oligosaccharide 30% (Min) 24% HPLC containing Carbohydrates

[0041] The limits of the various components in the purified composition of the present invention are optimized for human use. As compared to the natural components and their limits in bovine colostrum, as shown in Table 3, it is evident that the optimization method causes the limits or percentages of components to differ substantially from their natural limits. As can be appreciated, the optimization causes the components to be present in amounts that are ideal for targeting the human mucosal barrier.

TABLE-US-00003 TABLE 3 Typical components and percentages in bovine colostrum (Biodane Phamra, Contents in bovine colostrum (https://biodanepharma.info/contents-in-bovine-colostrum). Bovine Colostrum Limits IgG1 34.0-87.0 g/L IgG2 1.6-6.0 g/L IgA 1.7-6.2 g/L Fat 6.7% Ash 16442.7 mg/kg Oligosaccharide 2.5% containing Carbohydrates

[0042] In an alternate embodiment, the composition comprises the following components in the following amounts: Bioactive Peptides including PrP at a concentration of 8.40%, IgG at a concentration of 37.35%, IgM at a concentration of 3.27%, Lactoperoxidase at a concentration of 0.19%, Alpha-Lactalbumin at a concentration of 6.72%, water at a concentration of <7.42%, sIgA at a concentration of 4.20%, Lactoferrin at a concentration of 0.37%, Beta-lactoglobulin at a concentration of 14.01%, Animal Serum Albumin at a concentration of 2.43%, milk minerals at a concentration of 14.57%, growth factors and minor components at a concentration of 1.03%, and milk oligosaccharides at a concentration of 1.00%. The purified composition comprises the components and percentages thereof as listed in Table 4.

TABLE-US-00004 TABLE 4 Components in the Composition Bioactive Peptides including PrP 8.40% IgG 37.35% IgM 3.27% Lactoperoxidase 0.19% Alpha-Lactalbumin 6.72% Water <7.47% sIgA 4.20% Lactoferrin 0.37% Beta-lactoglobulin 14.01% Animal Serum Albumin 2.43% Milk minerals 14.57% Growth factors and minor components 1.03% Milk Oligosaccharides 1.00%

[0043] In an alternate embodiment, the purified composition comprises the following components in the following ranges: Bioactive Peptides including PrP in the range of 0-40%, IgG in the range of 0-60%, IgM in the range of 0-40%, Lactoperoxidase in the range of 0-40%, Alpha-Lactalbumin in the range of 0-40%, water in the range of 0-10%, sIgA in the range of 0-40%, Lactoferrin in the range of 0-40%, Beta-lactoglobulin in the range of 0-40%, Animal Serum Albumin in the range of 0-40%, milk minerals in the range of 0-40%, growth factors and minor components in the range of 0-40%, and milk oligosaccharides in the range of 0-40%. The components and percentages thereof as listed in Table 5.

TABLE-US-00005 TABLE 5 Components in the Composition Bioactive Peptides including PrP 0-40% IgG 0-60% IgM 0-40% Lactoperoxidase 0-40% Alpha-Lactalbumin 0-40% Water 0-10% sIgA 0-40% Lactoferrin 0-40% Beta-lactoglobulin 0-40% Animal Serum Albumin 0-40% Milk minerals 0-40% Growth factors and minor components 0-40% Milk Oligosaccharides 0-40%

[0044] The method of manufacturing the composition comprises the steps of pasteurization, centrifuging, filtration, and evaporation. In the preferred embodiment, the raw animal colostrum undergoes HTST and/or VAT pasteurization. As can be appreciated, HTST, or high temperature short time pasteurization rapidly brings the product to a high temperature, holds it at temperature for a short period, and rapidly cools the composition. Additionally, VAT, or batch pasteurization, heats the product at 145 F. (63 C.) for 30 minutes. The pasteurization process destroys all disease-producing bacteria, as well as 90-99% of all other bacteria that may affect product quality. The type and time of pasteurization can be readily determined by one of skill in the art, and can be carried out based on the desired final product. Such pasteurization processes are then followed by in-direct heat spray drying.

[0045] The centrifuging step separates the components of the colostrum based on the sedimentation principle. Centrifuging is particularly useful for removing casein from the raw material. The type and time for centrifugation can be readily determined by one of skill in the art, and can be carried out based on the desired components to be included in the final product.

[0046] Purification, likewise, can be used to remove one or more of lactose, casein protein, fats, and oils from the raw material. As can be appreciated, a variety of purification protocols are known and can be used to remove components from the colostrum. The type of purification can be readily determined by one of skill in the art, and can be carried out based on the desired components to be included in the final product.

[0047] It is desirable that the final product is free of allergens and contaminants. In example 1, the final product as listed in Table 1 above was subjected to AOAC analysis for contaminants. The results are provided in Table 6 and shown in FIG. 3.

TABLE-US-00006 TABLE 6 Microbial Standards Microbial Standards Limits Typical Method APC 10,000 cfu/g (Max) In spec AOAC 986.33, 989.10 Coliforms 10 cfu/g (Max) Absent AOAC 991.14 Escherichia coli Absent/g Absent AOAC 991.14 Yeast & Molds 10 cfu/g (Max) <10 cfu AOAC 997.02 Salmonella Absent/375 g Absent AOAC 2011.03 Listeria Absent/25 g Absent AOAC 2013.10 Coagulase positive Absent/g Absent AOAC 2003.08 Staph. aureus

[0048] Once the steps of pasteurization, centrifugation, and purification are complete, the composition is devoid of one or more of lactose, casein protein, fats, and oils. What remains are bioactive peptides, proteins, and oligosaccharides. The purified composition can then optionally be combined with a prebiotic, a natural sweetener (i.e., stevia and/or a sugar composite), and flavoring, and/or other vitamin and minerals, and can then be agglomerated with sunflower lecithin.

[0049] The final filtrate is preferably combined with other ingredients. In a non-limiting embodiment, the final filtrate is combined with additional prebiotic fiber. In a non-limiting embodiment, the final filtrate is combined with a natural sweetener selected from stevia, monkfruit, and sugar. In a non-limiting embodiment, the final filtrate is combined with additional vitamins, herbs and micronutrients. In a non-limiting embodiment, the final filtrate is combined with flavoring ingredients. Following the addition of other ingredients, the composition preferably undergoes agglomeration with sunflower lecithin in order to produce a water dispersible powder.