Evaluating Butyrate and Butyrate + Polyphenol for Gut Health
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
This study is testing whether two different treatments, Butyrate alone and Butyrate with Polyphenols, can improve gut health and related symptoms for people who have digestive issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Supplement Formulators, Inc. Industry-sponsored |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06419231 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness and safety of two formulations: Butyrate and Butyrate combined with Polyphenols, on gut health and related symptoms. It employs a double-blind, randomized, placebo-controlled design, enrolling up to 105 participants who will be monitored over a 28-day period. Participants will undergo laboratory assessments and complete various questionnaires to evaluate gastrointestinal symptoms and quality of life. Remote video calls will facilitate participant engagement throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21-70 who experience gastrointestinal symptoms at least three times a week.
Not a fit: Patients with a history of gastrointestinal disease or those currently on certain restricted diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new dietary interventions for improving gut health and alleviating gastrointestinal discomfort.
How similar studies have performed: Previous studies have shown promising results with butyrate supplementation for gut health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ambulatory, male or female, 21-70 years of age 2. A BMI of 18.5 -34.9 3. . Experiences at least three conditions involving gastrointestinal health on a weekly basis 4. Are comfortable fasting overnight 5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days 6. Considered to be generally healthy on the basis of medical history 7. Willing to follow study instructions, including compliance with the study procedures and requirements Exclusion Criteria: 1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick 2. Currently on a galactose/lactose restricted diet 3. Having taken proton pump inhibitors within the past 3 months 4. History of oral antibiotic use within the past 3 months 5. Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters 6. A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study 7. Current or previous history of diabetes 8. History of a major change in dietary habits with the past 1 month 9. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose 10. Women who are lactating, pregnant or planning pregnancy within the next two months 11. Having donated blood or received a blood transfusion within 30 days before screening 12. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening
Where this trial is running
Fort Lauderdale, Florida
- Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Swick, Ph.D — Life Extension
- Study coordinator: Steven Hirsh, RPh, DPM
- Email: shirsh@lifeextension.com
- Phone: 954-202-7679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.