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

Last updated: January 27, 2026
Sponsor: Supplement Formulators, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Constipation

Colic

Treatment

Placebo

Butyrate + Polyphenol Formulation

Clinical Study ID

NCT07371975
CL116
  • Ages 25-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, age 25-70 years

  2. Body mass index 18.5-34.9 kg/m2

  3. A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinalsymptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may beincluded at the discretion of the PI/Sub-I

  4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, orconstipation)

  5. Healthy based on medical history and without chronic disease (unless permitted inthe judgment of the PI/Sub-I)

  6. Weight stable for the past six months (±6 lbs.)

  7. Willing and able to give written informed consent

  8. Ability to communicate and read in English

  9. Ability to comply with study requirements

Exclusion

Exclusion Criteria:

  1. Currently participating in another clinical research study

  2. Pregnant, planning pregnancy, or breastfeeding

  3. Unable to swallow capsules, tablets, or softgels

  4. Male participants and females of childbearing potential who are unwilling to use anacceptable method of contraception from screening through 30 days after studycompletion.

  5. Typically goes longer than 3 days without a bowel movement

  6. Current diagnosis of cardiovascular disease, history of an abnormalelectrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except fornon-melanoma skin cancer) within the past 5 years

  7. Having had a medical or surgical event in the past 5 years involvinghospitalization, outpatient, or emergency care that requires ongoing monitoring.

  8. Planning to undergo a major medical procedure or surgical event within the next 30days

  9. Currently being treated for any infectious disease

  10. Currently consuming more than 6 standard alcoholic drinks per week for women and 10drinks per week for men (a standard alcoholic drink is defined as one bottle/can ofbeer, one glass of wine, or one ounce of hard liquor)

  11. Smoking or use of nicotine products daily within 30 days prior to screening

  12. Using substances of abuse or recreational drugs/substances, includingtetrahydrocannabinol (THC), within the past 14 days

  13. History of intolerance or allergic reaction to product ingredients, includingbutyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamonextract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)

  14. Having donated blood or received a blood/plasma transfusion within 30 days beforebaseline

  15. History of a major change in dietary habits within the past 1 month

  16. Currently taking any supplements containing butyrate, tributyrin, or polyphenols andnot willing to stop for the duration of study participation

  17. Currently taking any laxatives on a daily basis

  18. Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior toscreening.

  19. On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.

  20. History of oral or IV antibiotic use within the past 3 months prior to Baseline

  21. Not willing to refrain from taking any over-the-counter medications or supplementsfor gastrointestinal concerns or discomfort (except if on a stable dose for > 3months before Screening and unlikely to change) unless in the judgment of thePI/Sub-I

  22. Current or previous history of medically diagnosed and treated gastrointestinaldisease, including gallbladder problems, gallstones, biliary obstruction,inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiacdisease, or gastrointestinal cancer

  23. Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)

  24. Currently experiencing or previously having a gastrointestinal infection (viral orbacterial) or food poisoning within the past month

  25. Currently experiencing or previously having a parasitic infection within the past 3months

  26. Currently experiencing or having a history of severe endometriosis

  27. History of gastrointestinal surgery, which might influence gastrointestinal function

  28. History or presence of a clinically significant diagnosis or circumstance that, inthe judgment of the Study Investigator/Sub-I, would interfere with theinterpretation of the study results and preclude participation in the study -

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
October 16, 2025
Estimated Completion Date:
July 30, 2026

Study Description

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.

Connect with a study center

  • Life Extension Clinical Research, Inc.

    Fort Lauderdale 4155966, Florida 4155751 33304
    United States

    Active - Recruiting

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