USOO92481.58B2 (12) United States Patent (10) Patent No.: US 9.248,158 B2 BrOWn et al. (45) Date of Patent: Feb. 2, 2016 (54) HERBAL SUPPLEMENTS AND METHODS OF 2008/022O101 A1* 9, 2008 Buchwald-Werner ... A23L 1,293 USE THEREOF 424,728 2008/0268024 A1* 10, 2008 Rull Prous et al. ........... 424/439 (71) Applicant: KBS Research, LLC, Plano, TX (US) 2010, 0008887 A1 1/2010 Nakamoto et al. (72) Inventors: Kenneth Brown, Plano, TX (US); FOREIGN PATENT DOCUMENTS Brandi M. Scott, Plano, TX (US) FR 2770228 A1 * 4, 1999 WO 2012131728 A2 10, 2012 (73) Assignee: KBS RESEARCH, LLC, Plano, TX (US) OTHER PUBLICATIONS (*) Notice: Subject to any disclaimer, the term of this Zotte et al., Dietary inclusion of tannin extract from red quebracho patent is extended or adjusted under 35 trees (Schinopsis spp.) in the rabbit meat production, 2009, Ital J U.S.C. 154(b) by 0 days. Anim Sci., 8:784-786.* Becker, K., et al. “Effects of dietary tannic acid and quebracho tannin on growth performance and metabolic rates of common carp (21) Appl. No.: 14/072,502 (Cyprinus carpio L.), Aquaculture, May 15, 1999, vol. 175, Issues Filed: Nov. 5, 2013 3-4, pp. 327-335. (22) Durmic, Z. et al. “Bioactive plants and plant products: Effects on Prior Publication Data animal function, health and welfare'. Animal Feed Science and Tech (65) nology, Sep. 21, 2012, vol. 176, Issues 1-4, pp. 150-162. US 2014/01.41108A1 May 22, 2014 Search Report and Written Opinion mailed Jan. 29, 2014, in corre sponding International Patent Application No. PCT/US2013/ Related U.S. Application Data O6855O. (60) Provisional application No. 61/728,893, filed on Nov. 21, 2012. * cited by examiner (51) Int. C. Primary Examiner — Terry A. McKelvey A636/77 (2006.01) Assistant Examiner — Catheryne Chen A6 IK36/534 (2006.01) (74) Attorney, Agent, or Firm — Ping Wang; Andrews Kurth A6 IK 36/24 (2006.01) LLP (52) U.S. C. CPC ................. A61K 36/77 (2013.01); A61K 36/24 (57) ABSTRACT (2013.01); A61 K36/534 (2013.01) In one embodiment, the present application provides an (58) Field of Classification Search herbal Supplement and method for treating bloating, consti None pation and/or weight gain in a human Subject comprising See application file for complete search history. orally administering to a subject in need thereof an effective amount of the herbal Supplement comprising a red quebracho (56) References Cited extract. In other embodiments, the Supplement may addition U.S. PATENT DOCUMENTS ally include a triterpenoid saponin, an anti-spasmodic agent, or both. 2007/0249543 A1* 10, 2007 Zadini et al. .................... 514, 26 2007/0254050 A1 1 1/2007 Quartet al. 12 Claims, No Drawings US 9.248,158 B2 1. 2 HERBAL SUPPLEMENTS AND METHODS OF directly influences the colonic transit time, colonic motility, USE THEREOF and rectal sensorimotor function resulting in lowered pain threshold. This application claims priority to U.S. Provisional Patent There is growing evidence that the microbiota plays a Application No. 61/728,893, filed Nov. 21, 2012. The entirety critical role in the determinant of nutrient uptake, energy of the aforementioned application is incorporated herein by regulation and ultimately weight and metabolic disorders. reference. Gut microbes can influence both the harvest of energy from components of the diet and how energy is stored and FIELD expended. In this regard, methane-producing bacteria have 10 been found to be present in greater abundance in obese mice The present application relates to herbal compositions and and humans compared with lean animals and individuals. It methods for treating diseases associated with bloating, con has been shown that hydrogen transfer between bacterial and stipation and/or weight gain. More particularly, the present archaeal species may increase energy uptake by the large application relates to an herbal Supplement and method com intestine via methanogens by removing fermentation inter prising oral administration of condensed tannins in human 15 mediates. Such as H2 or formate. This allows greater produc Subjects for treating bloating, constipation and/or weight tion and availability of short chain fatty acids for absorption across the intestinal lumen. The methane produced also acts ga1n. as a local paralytic allowing food Substrates to have longer contact with the absorptive villi in the small bowel. BACKGROUND Treatment options for gastrointestinal disorders and obe sity are limited. For example, although there are treatment Bowel disorders are often characterized by bloating and options for IBS including the use of bulking agents, such as constipation and are thought to affect at least 20% of the fiber, antispasmodics, antidepressants, and more recently population. Yet, to date no effective therapy is available. Such probiotics and antibiotics, such treatment options are not bowel disorders include irritable bowel syndrome (IBS), 25 sufficiently effective and do not treat the underlying problem. functional constipation, chronic pseudo-obstruction, and For example, bulking agents have not been shown to demon chronic abdominal bloating syndrome. Symptoms include strate an improvement in global IBS symptoms and actually abdominal pain, constipation, bloating, acid reflux, flatu have been shown to increase bloating and pain. Anti-spas lence, nausea and Vomiting, chronic lethargy and sleep dis modics available in the US for IBS include dicyclomine, orders. 30 hyoscyamine, and peppermint oil. A recent meta-analysis IBS is a gastrointestinal disorder characterized by chronic found only peppermint oil to be effective in improving global abdominal pain and altered bowel habits with either consti IBS symptoms. Antidepressants have shown poor and con pation (IBS-C), diarrhea (IBS-D) or both (IBS-M; mixed flicting results, ultimately demonstrating no relief in Symp type). IBS is the most commonly diagnosed GI condition. It is toms. Regarding probiotics, a large meta-analysis demon second only to the common cold as a cause of absence from 35 strated no Superior effect over placebo. And, of course, work. It is estimated that around 20% of the general popula obesity is an epidemic problem with few effective options. tion suffers from IBS, resulting in increased health care costs. Surveys have demonstrated that less than 14% of patients Annual direct and indirect costs are reported to be of up to S30 with IBS are satisfied with their treatment. Presently, there are billion. few dependable pharmaceutical treatment options for IBS or Functional constipation is the most common gastrointesti 40 obesity. nal complaint affecting the 63 million Americans with IBS. In view of the current shortcomings associated with bowel IBS is often characterized by hard stools or straining or hav disorder treatments, including IBS and functional constipa ing fewer than 3 bowel movements a week at least 25 percent tion, as well as obesity or undesired weight gain, there is a of the time. need for new treatments. The present application addresses Despite the seriousness of IBS as a health care issue the 45 this need and provides new methods and formulations for underlying causes remain largely unknown. The traditional treating Such disorders or diseases. focus has been on alterations in the GI motility and on visceral hypersensitivity. Recent reports suggest that Small intestinal SUMMARY bacterial overgrowth (SIBO) may play a significant role in the development of IBS, as well as obesity and type II diabetes. 50 The present application relates to herbal compositions and For example, multiple studies have demonstrated excessive methods for treating diseases associated with bloating, con coliform bacteria in the small intestines of IBS patients. stipation and/or weight gain. In one aspect, the present appli Methanogenic archaebacteria are an important group of cation provides a method for treating bloating, constipation or gut colonizing bacteria contributing to SIBO that grow pri weight gain comprising orally administering to a human Sub marily under anaerobic conditions and produce methane 55 ject in need thereof an herbal Supplement comprising con (CH) as a by-product of fermentation. The degradation of densed tannins in an amount effective to reduce bloating, carbohydrates by enteric bacteria, including methanogenic constipation and/or weight gain. bacteria, leads to the production of short chain fatty acids In Some embodiments, the method employs an herbal (butyrate, propionate, acetate), as well as carbon dioxide, Supplement comprising a red quebracho extract. In other hydrogen and methane. These products are associated with 60 embodiments, the Supplement additionally includes eitheran acidic stools, abdominal distension, flatulence, diarrhea, and herbal composition comprising a triterpenoid Saponin, an constipation. Methanogenic bacteria are unique, in that their herbal composition comprising an anti-spasmodic agent, or metabolism increases in the presence of products from other both. bacteria. They use hydrogen and ammonia from other bacte The compositions and methods may be applied to treating ria as Substrates for the production of methane. Intestinal 65 bowel disorders characterized by bloating or constipation, as methane production has been linked to IBS-C, functional well as obesity and other conditions characterized by unde constipation, obesity and type II diabetes. The methane sirable weight gain. Exemplary bowel disorders for treatment US 9.248,158 B2 3 4 include irritable bowel syndrome (IBS), functional constipa embodiments shown, but is to be accorded