A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Supplement Formulators, Inc.
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.
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.
Eligibility
- Age range
- 25–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 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 4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation) 5. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I) 6. Weight sta…
Interventions
- Dietary SupplementButyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation
- Dietary SupplementPlacebo
Placebo
Location
- Life Extension Clinical Research, Inc.Fort Lauderdale, Florida