IP Library Granted Patent US 12,208,081
Granted Patent B2
US 12,208,081 · App. 18/073,632 · Granted Jan 28, 2025

Tannin-containing gastrointestinal formulations and methods of use

Inventors: Jess Dreher Reed (Madison, WI); Dhanansayan Shanmuganayagam (Madison, WI); Christian Gerald Krueger (Cambridge, WI); Kenneth Allan Kudsk (Madison, WI); Joseph Francis Pierre (Chicago, IL); Aaron F. Heneghan (Middleton, WI); Rodrigo P. Feliciano (Düsseldorf, DE)
Assignee: Wisconsin Alumni Research Foundation
A61K31/353A23L33/10A23L33/115A23L33/17A23L33/40A61K9/0029A23V2002/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,208,081
App. No.
18/073,632
Granted
Jan 28, 2025
Kind
B2
Abstract

Tannin-containing compositions and methods of using same to enhance or maintain immune function during simplified nutrition feeding. Pharmaceutical compositions, including enteral nutrition compositions, are provided. The compositions comprise such tannins as proanthocyanidins and/or hydrolysable tannins. Administering the tannins to the gastrointestinal tract of a subject receiving simplified nutrition, such as with enteral nutrition therapy or parenteral nutrition therapy, attenuates or prevents deleterious effects on the gastrointestinal immune system that would otherwise occur with the simplified nutrition.

Claims (39)

1. An enteral or parenteral nutrition composition, comprising:

one or more nutrients comprising:

amino acids and/or polypeptides in an amount of at least 16% of total calories in the composition; and

carbohydrates in an amount of at least 25% of total calories in the composition; and

proanthocyanidins from one or more sources selected from the group consisting of cranberries, blueberries, grapes, sorghum, pomegranates, and pine,

wherein:

the composition is in the form of a powder and comprises the proanthocyanidins in an amount of at least 0.1 wt %, or the composition is in the form of a liquid and comprises the proanthocyanidins in an amount of at least 0.1 mg/L.

2. The composition of claim 1 , wherein the composition comprises the proanthocyanidins in an amount effective to attenuate deleterious effects of an otherwise identical composition lacking the proanthocyanidins on intestinal barrier function when administered to a patient enterally or parenterally.

3. The composition of claim 1 , wherein the amino acids and/or polypeptides are included in the composition in an amount of at least 17% of total calories in the composition.

4. The composition of claim 1 , wherein the amino acids and/or polypeptides are included in the composition in an amount of at least 20% of total calories in the composition.

5. The composition of claim 1 , wherein the amino acids and/or polypeptides are included in the composition in an amount of 17-25% of total calories in the composition.

6. The composition of claim 1 , wherein the amino acids and/or polypeptides comprise hydrolyzed protein.

7. The composition of claim 1 , wherein the amino acids and/or polypeptides comprise amino acids.

8. The composition of claim 7 , wherein the composition is devoid of polypeptides.

9. The composition of claim 1 , wherein the carbohydrates are included in the composition in an amount of at least 30% of total calories in the composition.

10. The composition of claim 1 , wherein the carbohydrates are included in the composition in an amount of 25-48% of total calories in the composition.

11. The composition of claim 1 , wherein the carbohydrates comprise monosaccharides and/or disaccharides.

12. The composition of claim 1 , wherein:

the amino acids and/or polypeptides are included in the composition in an amount of at least 20% of total calories in the composition; and

the carbohydrates are included in the composition in an amount of at least 30% of total calories in the composition.

13. The composition of claim 1 , wherein:

the amino acids and/or polypeptides are included in the composition in an amount of 17-25% of total calories in the composition; and

the carbohydrates are included in the composition in an amount of 25-48% of total calories in the composition.

14. The composition of claim 1 , wherein the one or more nutrients further comprise fatty acids and/or fatty acid esters.

15. The composition of claim 14 , wherein the fatty acids and/or fatty acid esters are included in the composition in an amount of at least 30% of total calories in the composition.

16. The composition of claim 14 , wherein the fatty acids and/or fatty acid esters are included in the composition in an amount of 35-50% of total calories in the composition.

17. The composition of claim 14 , wherein the fatty acids and/or fatty acid esters comprise medium chain triglycerides.

18. The composition of claim 14 , wherein:

the amino acids and/or polypeptides are included in the composition in an amount of at least 20% of total calories in the composition;

the carbohydrates are included in the composition in an amount of at least 30% of total calories in the composition; and

the fatty acids and/or fatty acid esters are included in the composition in an amount of at least 30% of total calories in the composition.

19. The composition of claim 18 , wherein the proanthocyanidins comprise cranberry proanthocyanidins.

20. The composition of claim 14 , wherein:

the amino acids and/or polypeptides are included in the composition in an amount of 17-25% of total calories in the composition;

the carbohydrates are included in the composition in an amount of 25-48% of total calories in the composition; and

the fatty acids and/or fatty acid esters are included in the composition in an amount of 35-50% of total calories in the composition.

21. The composition of claim 20 , wherein the proanthocyanidins comprise cranberry proanthocyanidins.

22. The composition of claim 1 , wherein the proanthocyanidins comprise cranberry proanthocyanidins.

23. A method of preparing the enteral or parenteral nutrition composition of claim 1 , the method comprising adding the proanthocyanidins to the one or more nutrients.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 2, 2022
From: REED, JESS; HENEGHAN, AARON; SHANMUGANAYAGAM, DHANANSAYAN; KRUEGER, CHRISTIAN; FELICIANO, RODRIGO; KUDSK, KENNETH; PIERRE, JOSEPH
To: WISCONSIN ALUMNI RESEARCH FOUNDATION
Reel/Frame 061953/0087 →
Continuity (6)
Continuation 17111948 · Dec 4, 2020
Continuation 16102844 · Aug 14, 2018
Continuation 15347204 · Nov 9, 2016
Continuation 14152267 · Jan 10, 2014
Provisional Application 61751647 · Jan 11, 2013
Related Publication 20230114648A1 · Apr 13, 2023
References Cited (63)
US 4497800A · Larson et al. · 1985 [cited by applicant]
US 4938949A · Borch et al. · 1990 [cited by applicant]
US 5229136A · Mark et al. · 1993 [cited by applicant]
US 5723446A · Gray et al. · 1998 [cited by applicant]
US 6420572B1 · Romanczyk, Jr. et al. · 2002 [cited by applicant]
US 7122574B2 · Romanczyk et al. · 2006 [cited by applicant]
US 7196065B2 · Ernest · 2007 [cited by applicant]
US 7758893B2 · Hageman et al. · 2010 [cited by applicant]
US 7790209B2 · Ohmori et al. · 2010 [cited by applicant]
Beecher; Overview of Dietary Flavonoids: Nomenclature, Occurrence and Intake; Nutrition (2003) 32485-3254S. [cited by applicant]
Bergstrom et al., Muc2 Protects against Lethal Infectious Colitis by Disassociating Pathogenic and Commensal Bacteria from the Colonic Mucosa, PLoS Pathog (2010) 6:dl000902. [cited by applicant]
Braga et al, ESPEN Guidelines on parenteral nutrition: Surgery, Clinical Nutrition (2009) 28:378-386. [cited by applicant]
Conterno et al, Obesity and the gut microbiota: does up-regulating colonic fermentation protect against obesity and metabolic disease?, Genes Nub. (2011) 6:241-260. [cited by applicant]
De Vrese et al., Probiotics, prebiotics and synbiotics, Adv Biochein Eng Biotechno] (2008) 111:1-66. [cited by applicant]
Feng et al, Specific degree-of-polymerization of A-tvpe proanthocyanidin oligomers impacts [cited by applicant]
Fisher et al., Automated approach for ribasomal intergenic spacer analysis of microbial diversity and its application to freshwater bacterial communities, App Environ Microbiol (1999) 65(1G}:4630-4636. [cited by applicant]
Gauthier et al., Treatment of urinary tract infections among febrile young children with daily intravenous antibiotic therapy at a day treatment center. Pediatrics 2004; 114;e469, DOI: 10.1542/peds.2004-0421. [cited by applicant]
Guamer, F. Role of intestinal flora in health and disease Nutr Hosp. (2007) 22 Suppl 2:14-19. [cited by applicant]
Hanton, S.D., Mass spectrometry of polymers and polymer surfaces, Chem. Rev. (2001) 101:527-570. [cited by applicant]
Houde et al., Protective effects of grape seed proanthocyanidins against oxidative stress induced by lipopolysaccharides of periodontopathogens, J Periodontol (2006) 77(8):1371-1379. [cited by applicant]
Howell et al, Dosage effect on uropathogenic [cited by applicant]
Enteral and Parenteral Nutrition, American College of Gastroenterology, hRp://patients.gi.org/topics/enteral-and-parenteral-nutrition/, accessed Sep. 29, 2015. [cited by applicant]
Jepson et al, Cranberries for preventing urinary tract infections (Review) The Cochrane Collaboration Issue 4 (2009). [cited by applicant]
Jolliet et al. Enteral nutrition in intensive care patients: a practical approach, Intensive Care Med (1998) 24:848-859. [cited by applicant]
Kajiura et al., Change of intestinal microbiota with elemental diet and its impact on therapeutic effects in a murine model of chronic colitis, Dig. Dis. 8ci (2009) 54(9):1892-1900. [cited by applicant]
Kang et ah, p90 ribosomal S6 kinase 2 promotes invasion and metastasis of human head and neck squamous cell carcinoma cells, J. Clin. Invest (2010) 120:1165-1177. [cited by applicant]
Kirby et al, Enteral and parenteral nutrition, (2011), http://patients,gi.org/topics/enteral-and-parepteraLiiutrition/, accessed Sep. 29, 2015. [cited by applicant]
Kovacs et al., A systematic assessment of automated ribosomal intergenic spacer analysis (ARISA) as a tool for estimating bacterial richnesss, Res Microbiol (2010) 161(3):192-197. [cited by applicant]
Krueger et al., Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry of heteropolyflavan-3-ols and glucosylated heteropolyflavans in sorghum [Sorghum bicolor (L,) Moench], J. Agric. Food Chem. (2… [cited by applicant]
Lewis, R.J., John Wiley & Sons, New York, N.Y., 2001. [cited by applicant]
Li et al, Effects of parenteral and enteral nutrition 011 gut-associated lymphoid tissue, J. Trauma (1995) 39:44-51. [cited by applicant]
Li et al, Therapeutic effect and mechanism of proanythocyanidins from grape seeds in rats with TNBS-induced ulcerative colitis. Can J. Physiol. Pharmacol (2008) 86:841-849. [cited by applicant]
Maccaferri et al., Metagenomics: key to human gut microbiota Dig. Dis. (2011) 29(6):525-530. [cited by applicant]
Martin et al., Development of a novel pomegranate standard and new method for the quantitative measurement of pomegranate polyphenols, J. Sci Food Agric (2009) 89:157-162. [cited by applicant]
McClave et al, Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically IIS Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutri… [cited by applicant]
Moco, S. et al., Metabolomics view on gut microbiome modulation by polyphenol-rich foods, J. Proteome Res. (2012) 11(10):4781-4790. [cited by applicant]
Monograph, Oligomeric proanthocyanidins (QPCs), Alternative Medicine Review (2003)8(4):442-50. [cited by applicant]
Neto et al., MALDI-TOF MS Characterization of proanthocyanidins from cranberry fruit ( [cited by applicant]
Ofman et al., Clinical economics review: nutritional support, Ailment Pharmacol Their (1997) 11:453-471. [cited by applicant]
Ott et al., Reduction in diversity of the colonic mucosa associated bacterial microflora in patients with active inflammatory bowel disease, Gut (2004) 53{5}:685-693. [cited by applicant]
Ottaviani et al.. Intake of dietary procyanidins does not contribute to the pool of circulating flavanols in humans, Am J Clin Nutr (2012) 95(4):851-858. [cited by applicant]
Parrish et al, Enteral formula selection: A review of selected product categories, Practical Gastroenterology (2005) Series No. 28:44-74. [cited by applicant]
Parrish et al., Elemental and semi-elemental formulas: Are they superior to polymeric formulas? Practical Gastroenterolojgv (2005) Series No. 34:59-72. [cited by applicant]
Pierre. Parenteral and elemental nutrition decreases intestine mucosal immunity, Which is partially restored by dietary proanthocyanidins and IL,-25. (2012) Doctoral Thesis. [cited by applicant]
Pierre et al., Cranberry Proanthocyanidins Improve the Gut Mucous Layer Morphology and Function in Mice Receiving Elemental Enteral Nutrition) Journal of Parenteral and Enteral Nutrition (2013) 37(3):401-409 e-published… [cited by applicant]
Pierre et ai, Cranberry Proanthocyanidins Improve Intestinal slgA During Elemental Enteral Nutrition Journal of Parenteral and Enteral Nutrition (2013). [cited by applicant]
Porter et al, Cranberry proanthocyanidins associate with low-density lipoprotein and inhibit in yjtro Cu [cited by applicant]
Preisner et al, Enteral feeding with a solution enriched with antioxidant vitamins A, C, and E enhances the resistance to oxidative stress, Crit Care Med (2000)28(12):3828-3832. [cited by applicant]
Quideau et al., Ellagitannin Chemistry, Chem. Rev. (1996) 96 :475-503. [cited by applicant]
Reed et al., MALDI-TOF mass spectrometry of oligomeric food polyphenols, Phytochem (2005) 66:2248-2263. [cited by applicant]
Sano et al., Parenteral nutrition maintains pulmonary IgA antibody transport capacity, but not active transport, following injury, Am J. Surg. (2009) 198:105-109. [cited by applicant]
Scalbert et al, Dietary polyphenols and the prevention of diseases, Grit Rev Food Sci Nutr. (2005) 45(4);287-306. [cited by applicant]
Singleton et al., Colorimetry of Total Phenolics with Phosphomolybdic-Phosphotungstic Acid Reagents, Amer. J. Enology and Viticulture (1965) 16:144-58. [cited by applicant]
Sitren et al., parenteral nutrition in the mouse: development of a technique, J Parenter Enteral Nutr. (1983) 7:582-6. [cited by applicant]
Tuohy et al, Up-regulating the Human Intestinal Microbiome Using Whole Plant Foods, Polyphenos and/or Fiber, J Agric Food Chem. (2012) 60(36):8?76-8782. [cited by applicant]
Walpole et al, The weight of nations: An estimation of adult human biomass, Public Health (2012) 12:439. [cited by applicant]
White et al., Proximate and polyphenolic characterization of cranberry pomace, J. Agric Food Chem. (2010) 58:4030-6. [cited by applicant]
Yuste et al, The effect of proanthocyanidin-rich hulls and proanthocyamdin extracts from bean ( [cited by applicant]
U.S. Appl. No. 17/111,948, Jess Dreher Reed, filed Dec. 4, 2020. [cited by applicant]
U.S. Appl. No. 16/102,844, Jess Dreher Reed, filed Aug. 14, 2018. [cited by applicant]
U.S. Appl. No. 15/347,204, Jess Dreher Reed, filed Nov. 9, 2016. [cited by applicant]
U.S. Appl. No. 14/152,267, Jess Dreher Reed, filed Jan. 10, 2014. [cited by applicant]
U.S. Appl. No. 61/751,647, Jess Dreher Reed, filed Jan. 11, 2013. [cited by applicant]