Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males.
Maartje C P Cleophas, Jacqueline M Ratter, Siroon Bekkering...
https://pubmed.ncbi.nlm.nih.gov/30692581Actively Recruiting
Phase Not Applicable
Age: 25Years - 70Years
All Genders
Healthy Volunteers
ID07371975
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Led by Supplement Formulators, Inc. · Updated on 2026-01-29
124
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a butyrate and polyphenol formulation on gut health and related symptoms in healthy adults aged 25 to 70 who experience moderate to severe gastrointestinal discomfort. The study aims to understand how this formulation affects the gut microbiome and gastrointestinal symptoms using questionnaires and lab assessments. This is a double-blind, randomized, placebo-controlled study sponsored by Supplement Formulators, Inc. Participants will be randomly assigned to receive either the butyrate plus polyphenol formulation or a placebo. The treatment period lasts 14 days, during which participants take the assigned supplement. The study includes laboratory testing to assess the gut microbiome and various questionnaires to evaluate gastrointestinal symptoms and quality of life. During the study, participants will complete laboratory assessments and several questionnaires, including the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome, digestion-related quality of life surveys, and stool form scales. Researchers will monitor changes in gut microbiome composition and gastrointestinal symptoms over the 14-day period. The study also tracks safety and symptom improvement through standardized scales and quality of life measures.
CONDITIONS
Brief Title
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Who Can Participate
Age: 25Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female, age 25-70 years
- Body mass index 18.5-34.9 kg/m2
- GSRS-IBS score of 21 or higher indicating moderate or severe gastrointestinal symptoms (or lower at investigator discretion)
- Experiencing at least three weekly symptoms such as gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation
- Healthy based on medical history without chronic disease unless allowed by investigator
- Weight stable within ±16 lbs for the past six months
- Willing and able to provide written informed consent
- Able to communicate and read in English
- Able to comply with study requirements
You will not qualify if you...
- Currently enrolled in another clinical research study
- Pregnant, planning pregnancy, or breastfeeding
- Unable to swallow capsules, tablets, or softgels
- Male or female participants of childbearing potential unwilling to use contraception from screening through 30 days post-study
- Typically goes longer than 3 days without a bowel movement
- Diagnosis of cardiovascular disease, abnormal ECG history, diabetes, or cancer (except non-melanoma skin cancer) in past 5 years
- Recent medical or surgical events requiring hospitalization or ongoing monitoring within past 5 years
- Planning major medical procedure or surgery within 30 days
- Being treated for any infectious disease currently
- Consuming more than 6 (women) or 10 (men) alcoholic drinks per week
- Daily smoking or nicotine use within 30 days prior to screening
- Use of recreational drugs including THC within past 14 days
- History of allergy or intolerance to study product ingredients
- Blood donation or transfusion within 30 days before baseline
- Major dietary changes within past month
- Taking supplements containing butyrate, tributyrin, or polyphenols and unwilling to stop during study
- Daily use of laxatives
- Started GLP-1 medication within 3 months prior to screening
- On stable proton pump inhibitors within 3 months prior to screening
- Antibiotic use within 3 months prior to baseline
- Unwilling to refrain from OTC GI medications or supplements unless stable for over 3 months
- History or current diagnosis of gastrointestinal diseases including IBD, Crohn's, Ulcerative Colitis, Celiac disease, GI cancer
- Diagnosed or treated for Irritable Bowel Syndrome currently
- Recent gastrointestinal infection or food poisoning within past month
- Parasitic infection within past 3 months
- Severe endometriosis history or current
- History of GI surgery affecting function
- Any other significant condition that may interfere with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants receive either the butyrate-polyphenol formulation or a placebo to evaluate effects on gut health and associated symptoms.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33304
Actively Recruiting
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Research Team
S
Steven Hirsh
B
Barbara Martinez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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B A Conley, M J Egorin, N Tait...
https://pubmed.ncbi.nlm.nih.gov/9533530The Role of Polyphenols in Human Health and Food Systems: A Mini-Review.
Hannah Cory, Simone Passarelli, John Szeto...
https://pubmed.ncbi.nlm.nih.gov/30298133Current evidence on the effect of dietary polyphenols intake on chronic diseases.
Chiara Costa, Aristidis Tsatsakis, Charalampos Mamoulakis...
https://pubmed.ncbi.nlm.nih.gov/29042289Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial.
Fernanda Cristofori, Francesco Maria Calabrese, Ilaria Iacobellis...
https://pubmed.ncbi.nlm.nih.gov/40635319Butyrate's role in human health and the current progress towards its clinical application to treat gastrointestinal disease.
Kendra Hodgkinson, Faiha El Abbar, Peter Dobranowski...
https://pubmed.ncbi.nlm.nih.gov/36502573Dietary Polyphenol Intake in US Adults and 10-Year Trends: 2007-2016.
Qiushi Huang, Barbara H Braffett, Samuel J Simmens...
https://pubmed.ncbi.nlm.nih.gov/32807722Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: A population study.
Brjánn Ljótsson, Michael Jones, Nicholas J Talley...
https://pubmed.ncbi.nlm.nih.gov/32213021Cinnamon (Cinnamomum cassia) water extract improves diarrhea symptoms by changing the gut environment: a randomized controlled trial.
Soo-Yeon Park, Yong Dae Kim, Min Seo Kim...
https://pubmed.ncbi.nlm.nih.gov/36655542Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial.
Anna Pietrzak, Marcin Banasiuk, Mariusz Szczepanik...
https://pubmed.ncbi.nlm.nih.gov/36014789