IP Library › Granted Patent US 12,485,101
Granted Patent B2
US 12,485,101 · App. 19/003,866 · Granted Dec 2, 2025

Compositions containing short-chain fatty acid, methods of use, and methods of making thereof

Inventors: Bruce W. Kneller (Howell, NJ); Brandon S. Sojka (Port Jefferson, NY); Timothy N. Ziegenfuss (Chardon, OH)
Assignee: Velocity Life Sciences, LLC
A61K31/195A61K9/0056A61K9/0095
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Quick Facts
Patent No.
US 12,485,101
App. No.
19/003,866
Granted
Dec 2, 2025
Kind
B2
Abstract

A food product comprises L-lysine butyrate. The food product does not contain gluten and is not a baked product. Alternatively, the product is an oral dosage form comprising 25 mg to 5.0 g L-lysine butyrate. The oral dosage form is a tablet, a capsule, or a sealed packet containing powder. In another alternative, orally administering L-lysine butyrate may be used to: supplementing butyrate, provide a nootropic effect, treat a condition, losing weight, improve cognition, induce or maintain ketosis, improve athletic performance, or treat or mitigate mild-to-moderate pain.

Claims (23)

1 . A food product, comprising L-lysine butyrate, wherein the food product does not contain gluten and is not a baked product.

2 . The food product of claim 1 , wherein the food product is selected from the group consisting of ready-to-mix powder formulation, gummies, beverage, chocolate bars, cereals, lollipops, candies, lozenges, hard candies, chocolates, nut butters, ice cream, popsicles, yogurts, cottage cheese, powdered coffee creamers, gluten-free powdered waffle and gluten-free pancakes mixes, protein and nutritional drinks, hydration and electrolyte drinks and flavored drink mixes.

3 . The food product of claim 1 , wherein the food product is ready-to-mix powder formulation selected from the group consisting of infant formula, protein supplement, hydration drink and electrolyte drinks.

4 . The food product of claim 1 , further comprising:

a flavoring agent, and

a sweetening agent.

5 . The food product of claim 4 , wherein the food product is a ready-to-mix powder formulation, or a beverage.

6 . The food product of claim 5 , further comprising a probiotic bacteria or bacterial spores selected from the group consisting of Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, Escherichia, Bacillus , and mixtures thereof.

7 . The food product of claim 1 , wherein the L-lysine butyrate is present in an amount of 25 mg to 5 g.

8 . The food product of claim 1 , wherein the L-lysine butyrate is present in an amount of 500 mg to 2 g.

9 . A method of supplementing butyrate in a person, comprising orally administering the food product of claim 1 to the person.

10 . The method of claim 9 , further comprising:

preparing a beverage from a ready-to-mix powder comprising the L-lysine butyrate, by mixing the ready-to-mix powder with water or an aqueous liquid;

wherein the orally administering comprises the person drinking the beverage.

11 . The method of claim 9 , wherein the the food product orally administered contains 0.5 g to 2 g of the L-lysine butyrate.

12 . A method of providing a nootropic effect to a person, comprising supplementing butyrate in the person by the method of claim 9 .

13 . The method of claim 12 , wherein the nootropic effect provided is at least one effect selected from the group consisting of the person becoming, within 30 minutes of administration: more relaxed, less tired, more sociable, calm and able to concentrate on tasks more effectively.

14 . A method of treating a condition, comprising supplementing butyrate in the person by the method of claim 9 , wherein:

the person is a patient in need thereof,

the amount of L-lysine butyrate administered is an amount effect to treat the condition, and

the condition is at least one selected from the group consisting of solid tumor cancers, malignancies, hematological diseases, blood dyscrasias, epilepsy, metabolic diseases, type 2 diabetes, cardiovascular diseases, cardiac diseases, inflammatory diseases, arthritis, gut dysbiosis, constipation, diarrhea, leaky gut syndrome, Crohn's disease, inflammatory bowel disease, obesity, ulcerative colitis, drug addiction, alcoholism, depression, anxiety, Alzheimer's disease, pain and Parkinson's Disease.

15 . A method of losing weight, improving cognition, inducing or maintaining ketosis, or improving athletic performance, the method comprising supplementing butyrate in the person by the method of claim 9 .

16 . A method of treating or mitigating mild-to-moderate pain, the method comprising supplementing butyrate in the person by the method of claim 9 .

Continuity (2)
Continuation 18651454 · Apr 30, 2024
Related Publication 20250360098A1 · Nov 27, 2025
References Cited (70)
US 3015567A · Hause et al. · 1962 [cited by applicant]
US 3024272A · Hyson et al. · 1962 [cited by applicant]
US 5939455A · Rephacli · 1999 [cited by applicant]
US 10696437B2 · Geffard · 2020 [cited by applicant]
US 12226383B1 · Kneller · 2025 [cited by examiner]
US 20180353552A1 · De Vos et al. · 2018 [cited by applicant]
US 20220142978A1 · Arzumanyan · 2022 [cited by applicant]
CA 1209037 · 1986 [cited by applicant]
CN 114558061 · 2022 [cited by applicant]
WO 2010045368 · 2010 [cited by applicant]
WO 2016134858 · 2016 [cited by applicant]
WO 2023217675 · 2023 [cited by applicant]
WO WO2023217675A1 · 2023 [cited by examiner]
9, Jul. 29, 2024, U.S. Appl. No. 18/651,454, US. [cited by applicant]
11, Sep. 24, 2024, U.S. Appl. No. 18/651,454, US. [cited by applicant]
13, Nov. 18, 2024, U.S. Appl. No. 18/651,454, US. [cited by applicant]
2, Jan. 8, 2024, U.S. Appl. No. 18/651,454, US. [cited by applicant]
6, Jul. 2, 2025, U.S. Appl. No. 19/003,866, US. [cited by applicant]
Bartolomaeus, H. et al., “Short-chain fatty acid propionate protects from hypertensive cardiovascular damage”, Circulation, vol. 139, pp. 1407-1421, (2019). [cited by applicant]
Bourassa, M.W. et al., “Butyrate, neuroepigenetics and the gut microbiome: Can a high fiber diet improve brain health?”, Neuroscience Letters, vol. 625, pp. 56-63, (2016). [cited by applicant]
Byrne, C.S. et al., “The role of short chain fatty acids in appetite regulation and energy homeostasis”. International Journal of Obesity, vol. 39, pp. 1331-1338, (2015). [cited by applicant]
Canfora, E.E. et al., “Short-chain fatty acids in control of body weight and insulin sensitivity”. Nature Reviews, Endocrinology, vol. 11. pp. 577-591, (2015). [cited by applicant]
Conley, B.A. et al., “Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors”, Clinical Cancer Research, vol. 4, pp. 628-634, (1998). [cited by applicant]
Edelman, M.J. et al., “Clinical and pharmacologic study of tributyrin: an oral butyrate prodrug”, Cancer Chemotherapy and Pharmacology. vol. 51, pp. 439-444, (2003). [cited by applicant]
Egorin, M.J. et al., “Plasma pharmacokinetics of butyrate after intravenous administration of sodium butyrate or oral administration of tributyrin or sodium butyrate to mice and rats”, Cancer Chemotherapy and pharmacolo… [cited by applicant]
Faller, D.V. et al., “Short-term exposure to arginine butyrate, in combination with ganciclovir, is as effective as continuous exposure for virus-targeted therapy of EBV-positive lymphomas”, Blood, vol. 114, No. 22, abs… [cited by applicant]
Guerron, A.D. et al., “Functional and molecular effects of arginine butyrate and prednisone on muscle and heart in the mdx mouse model of Duchenne muscular dystrophy”, PLoS One, vol. 5, issue 6, e11220, pp. 1-12, (2010). [cited by applicant]
Hamer, H.M. et al., “Butyrate modulates oxidative stress in the colonic mucosa of healthy humans”, Clinical Nutrition, vol. 28, pp. 88-93, (2009). [cited by applicant]
Kaye. D.M. et al., “Deficiency of prebiotic fiber and insufficient signaling through gut metabolite-sensing receptors leads to cardiovascular disease”, Circulation, vol. 141, pp. 1393-1403, (2020). [cited by applicant]
Kim, S. et al., “Imbalance of gut microbiome and intestinal epithelial barrier dysfunction in patients with high blood pressure”, Clinical Science, vol. 132, pp. 701-718, (2018). [cited by applicant]
Kuefer. R. et al., “Antagonistic effects of sodium butyrate and N-(4-Hydroxyphenyl)-retinamide on prostate cancer”, Neoplasia, vol. 9, No. 3, pp. 246-253, (2007). [cited by applicant]
Bell, F.P., “The effect of fat-soluble xenobiotics on intestinal lipid, apoprotein, and lipoprotein synthesis and secretion”, In Fat Absorption, Chapter 7, pp. 167-188, (2018). [cited by applicant]
Lupton, J.R., “Microbial degradation products influence colon cancer risk: the butyrate controversy”, The Journal of Nutrition, vol. 134, No. 2, pp. 479-482, (2004). [cited by applicant]
Marques, F.Z. et al., “High-fiber diet and acetate supplementation change the gut microbiota and prevent the development of hypertension and heart failure in hypertensive mice”, Circulation. vol. 135. pp. 964-977, (2017… [cited by applicant]
McGovern, M.M. et al., “Biochemical effect of intravenous arginine butyrate in x-linked adrenoleukodystrophy”, The Journal of Pediatrics. vol. 142. No. 6, pp. 709-713, (2003). [cited by applicant]
McMahon, L. et al., “A randomized phase II trial of arginine butyrate with standard local therapy in refractory sickle cell leg ulcers”, British Journal of Haematology, vol. 151, pp. 516-524, (2010). [cited by applicant]
Merchak, A. et al., “Microbial metabolites and immune regulation: New targets for major depressive disorder”, Brain, Behavior, & Immunity—Health, vol. 9, No. 100169, pp. 1-10, (2020). [cited by applicant]
Miller, S.J., “Cellular and physiological effects of short-chain fatty acids”, Mini-Reviews in Medicinal Chemistry, vol. 4, pp. 839-845, (2004). [cited by applicant]
Miller, A.A. et al., “Clinical pharmacology of sodium butyrate in patients with acute leukemia”, European Journal of Cancer and Clinical Oncology, vol. 23, No. 9, pp. 1283-1287, (1987). [cited by applicant]
Morrison, D.J. et al., “formation of short chain fatty acids by the gut microbiota and their impact on human metabolism”, Gut Microbes, vol. 7, No. 3, pp. 189-200, (2016). [cited by applicant]
Moss, G.P. et al., “Glossary of class names of organic compounds and reactive intermediates based on structure”, Pure and Applied Chemistry, vol. 67, No. 8/9, pp. 1307-1375, (1995). [cited by applicant]
Mueller, N.T. et al., “Effects of high-fiber diets enriched with carbohydrate, protein, or unsaturated fat on circulating short chain fatty acids; results from the omniheart randomized trail”, The American Journal of Cl… [cited by applicant]
Newmark, H.L. et al., “Butyrate and phenylacetate as differentiating agents: Practical problems and opportunities”, Journal of Cellular Biochemistry, supplement 22, pp. 247-253, (1995). [cited by applicant]
Newmark, H.L. et al., “Butyrate as a differentiating agent: pharmacokinetics, analogues and current status”, Cancer Letters, vol. 78, pp. 1-5, (1994). [cited by applicant]
Offermanns, S. et al., “International union of basic and clinical pharmacology, LXXXII: Nomenclature and classification of hydroxy-carboxylic acid receptors (GPR81, GPR109A, and GPR109B)”, Pharmacological Reviews, vol. … [cited by applicant]
Perrine, S.P. et al., “A phase 1/2 trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies”, Blood, vol. 109, No. 6, pp. 2571-2578, (2007). [cited by applicant]
National Institutes of Health, “Probiotics Fact Sheet for Health Professionals, Office of Dietary Supplements”, National Institutes of Health, pp. 1-12, found at ods.od.nih.gov/factsheets/probiotics-healthprofessional, … [cited by applicant]
Rhys-Jones, D. et al., “Microbial interventions to control and reduce blood pressure in Australia (MICRoBiA): rationale and design of a double-blinded randomized cross-over placebo controlled trial”, Trials, vol. 22, pp… [cited by applicant]
Xu, Q. et al., “The influence of bile salts on small intestinal motility in the guinea pig in vitro”, Gastroenterology, vol. 103, pp. 29-35, (1992). [cited by applicant]
Seedorf, H. et al., “The genome of clostridium kluyveri, a strict anaerobe with unique metabolic features”, PNAS, vol. 105, No. 6, pp. 2128-2133, (2008). [cited by applicant]
Serpe, L. et al., “Cholesteryl butyrate solid lipid nanoparticles as a butyric acid pro-drug: effects on cell proliferation, cell-cycle distribution and c-myc expression in human leukemic cells”, Anti-Cancer Drigs, vol.… [cited by applicant]
Sher, G.D. et al., “Extended therapy with intravenous arginine butyrate in patients with β-hemoglobinopathies”, The New England Journal of Medicine, vol. 332, No. 24, pp. 1606-1610, (1995). [cited by applicant]
Urbano, A. et al., “Arginine butyrate downregulates p [cited by applicant]
Wong, J.M.W. et al., “Colonic health: Fermentation and short chain fatty acids”, Journal of Clinical Gastroenterology, vol. 40, No. 3, pp. 235-243, (2006). [cited by applicant]
Coppola S. et al., “The protective role of butyrate against obesity and obesity-related diseases”, Molecules, vol. 26, No. 3, 682. pp. 1-19, (2021). [cited by applicant]
Dziedzic, A. et al., “The power of psychobiotics in depression: A modern approach through the microbiota-gut-brain axis: A literature review”, Nutrients, vol. 16, No. 7, 1054, pp. 1-24 (2024). [cited by applicant]
Muller, M. et al., “Circulating but not faecal short-chain fatty acids are related to insulin sensitivity, lipolysis and GLP-1 concentrations in humans”, Scientific Reports, vol. 9, No. 1, pp. 1-9, (2019). [cited by applicant]
Chen, J.S. et al., “Short-chain fatty acid inhibitors of histone deacetylases: Promising anticancer therapeutics?”, Current Cancer Drug Targets, vol. 3, No. 3, pp. 219-236, (2003). [cited by applicant]
Kantharaj, E. et al., “Histone deacetylase inhibitors as therapeutic agents for cancer therapy: Drug metabolism and pharmacokinetic properties”, Drug Development—A case study based insight into modern strategies, pp. 10… [cited by applicant]
Kuksis, A., “Biochemistry of glycerolipids and formation of chylomicrons”, Fat Digestion and Absorption, Chapter 7, pp. 119-181, (2000). [cited by applicant]
Pizzorno, J.E. et al., “Inflammatory bowel disease, in the Clinician's handbook of natural medicine E-Book”, 3 [cited by applicant]
Scheppach. W. et al., “Effect of butyrate enemas on the colonic mucosa in distal ulcerative colitis”, Gastroenterology, vol. 103, No. 1, pp. 51-56, (1992). [cited by applicant]
Gasiorowska, A. et al., “Effects of microencapsulated sodium butyrate, probiotics and short chain fructooligosaccharides in patients with irritable bowel syndrome: A study protocol of a randomized double-blind placebo-c… [cited by applicant]
International Search Report and written opinion dated Sep. 21, 2025 for PCT application No. PCT/US2025/025762. [cited by applicant]
Just, B., “Nutrashure formulates ready-to-mix drinkable butyrate”, Food Business News, pp. 1-1. found at www.foodbusinessnews.net/articles/26008-nutrashure-formulates-ready-to-mix-drinkable-butyrate, (May 2, 2024). [cited by applicant]
Chany, C et al., “Antitumor effect of arginine butyrate in conjunction with corynebacterium parvum and interferon”, International Journal of Cancer, vol. 30, No. 4, pp. 489-493, (1982). [cited by applicant]
Banasiewicz, T. et al., “Determination of butyric acid dosage based on clinical and experimental studies—a literature review”, Gastroenterology Review/Przeglas Gastroenterologiczny, vol. 15, No. 2, pp. 119-125, (2020). [cited by applicant]
Database GNPD. “Formula for young children”, Mintel, Database accession No. 8516913, pp. 1-4, (2021). [cited by applicant]
Database GNPD, “Lactic food powder”, Mintel, Database accession No. 806652, pp. 1-3, (2007). [cited by applicant]
Extended European Search Report dated Jul. 10, 2025 for European application No. 25152687.7-1105, 51 pages. [cited by applicant]