A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms

Обзор

The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.

Подробное описание

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals.

Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.

Вмешательства

• Пищевая добавка Butyrate + Polyphenol Formulation
  Butyrate + Polyphenol Formulation
• Пищевая добавка Placebo
  Placebo

Первичные конечные точки

• The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version [Срок оценки: 14 days]
• Gut Microbiome Stool Test [Срок оценки: 14 days]

Вторичные конечные точки (5)

• Digestion-Associated Quality of Life Questionnaire (DQLQ) [Срок оценки: 14 days]
• Visual Analogue Scale (VAS) of abdominal pain [Срок оценки: 14 days]
• Bristol Stool Form Scale (BSFS) [Срок оценки: 14 days]
• Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI) [Срок оценки: 14 days]
• World Health Organization Quality of Life (WHOQOL-BREF) [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Male or female, age 25-70 years
• Body mass index 18.5-34.9 kg/m2
• A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
• Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
• Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
• Weight stable for the past six months (±6 lbs.)
• Willing and able to give written informed consent
• Ability to communicate and read in English
• Ability to comply with study requirements

Критерии исключения

• Currently participating in another clinical research study
• Pregnant, planning pregnancy, or breastfeeding
• Unable to swallow capsules, tablets, or softgels
• Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
• Typically goes longer than 3 days without a bowel movement
• Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years
• Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
• Planning to undergo a major medical procedure or surgical event within the next 30 days
• Currently being treated for any infectious disease
• Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
• Smoking or use of nicotine products daily within 30 days prior to screening
• Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
• History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
• Having donated blood or received a blood/plasma transfusion within 30 days before baseline
• History of a major change in dietary habits within the past 1 month
• Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
• Currently taking any laxatives on a daily basis
• Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
• On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
• History of oral or IV antibiotic use within the past 3 months prior to Baseline
• Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for > 3 months before Screening and unlikely to change) unless in the judgment of the PI/Sub-I
• Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer
• Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
• Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
• Currently experiencing or previously having a parasitic infection within the past 3 months
• Currently experiencing or having a history of severe endometriosis
• History of gastrointestinal surgery, which might influence gastrointestinal function
• History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator/Sub-I, would interfere with the interpretation of the study results and preclude participation in the study -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Life Extension Clinical Research, Inc. — Fort Lauderdale

Публикации

• Administration, D. o. H. a. H. S. U. S. F. a. D. (2005). Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers : pharmacology and toxicology. Center for Drug Evaluation and Research.
• Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7. PMID 30692581
• Conley BA, Egorin MJ, Tait N, Rosen DM, Sausville EA, Dover G, Fram RJ, Van Echo DA. Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors. Clin Cancer Res. 1998 Mar;4(3):629-34. PMID 9533530
• Cory H, Passarelli S, Szeto J, Tamez M, Mattei J. The Role of Polyphenols in Human Health and Food Systems: A Mini-Review. Front Nutr. 2018 Sep 21;5:87. doi: 10.3389/fnut.2018.00087. eCollection 2018. PMID 30298133
• Costa C, Tsatsakis A, Mamoulakis C, Teodoro M, Briguglio G, Caruso E, Tsoukalas D, Margina D, Dardiotis E, Kouretas D, Fenga C. Current evidence on the effect of dietary polyphenols intake on chronic diseases. Food Chem Toxicol. 2017 Dec;110:286-299. doi: 10.1016/j.fct.2017.10.023. Epub 2017 Oct 14. PMID 29042289
• Cristofori F, Calabrese FM, Iacobellis I, Santamaria M, Celano G, Ferrocino I, Di Sabato E, Pergola R, Dargenio VN, Paulucci L, De Angelis M, Francavilla R. Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):551-561. doi: 10.1002/jpn3.70154. Epub 2025 Jul 9. PMID 40635319
• Grosicki, G. (2021). Effects of 3-week Tributyrin Supplementation on the Gut Microbiome: A Pilot Study. Journal of the Academy of Nutrition and Dietetics, 121(9), A23.
• Hodges, J. Z., M.; Cao, S.; Pokala, A.; Rezaei, S.; Sasaki, G.; Vodovotz, Y.; Bruno, R. (2022). Catechin-Rich Green Tea Extract Reduced Intestinal Inflammation and Fasting Glucose in Metabolic Syndrome and Healthy Adults: A Randomized, Controlled, Crossover Trial. Current Developments in Nutrition, 6, 981. https://doi.org/10.1093/cdn/nzac068.010

Идентификаторы

NCT: NCT07371975 · CL116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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