Mixed Fiber Supplementation for Healthy Adults
Conditions
Keywords
Dietary fiber, Prebiotic, Stool regularity, Randomized controlled trial, Healthy adults, Microbiome, Microbiota, Fiber supplementation
Brief summary
This is a randomized, parallel-group interventional study evaluating the short-term gastrointestinal effects of a standardized multi-fiber supplement in healthy adults. Approximately 100 participants (50 per arm) aged 18 and older will be randomized to receive either the multi-fiber supplement or a control (flavoring agent only) daily for 10 days. Objectives include assessing effects on stool characteristics, specifically frequency and consistency, as well as changes in metagenomically inferred short-chain fatty acid production potential from the microbiota. Eligible participants must be free of chronic disease, acute illness, and recent antibiotic, probiotic, or prebiotic use. Total participation duration is 10 days.
Interventions
DIETARY_SUPPLEMENTPrebiotic
Formulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity
DIETARY_SUPPLEMENTPlacebo
Placebo supplementation intervention, with only flavoring agents and no prebiotic fiber
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* in self-reported good health (i.e. no chronic disease, no acute illness)
Exclusion criteria
* chronic disease * acute illness * antibiotic, or probiotic, or prebiotic use in the prior 3 months * allergies to any of the following: psyllium husk powder, mustard, sesame, soy, tree nuts, pectin, citric acid, wheat, milk, egg, beta-glucan, barley, inulin, agave, resistant maltodextrin, arabinoxylan * adherence to any food-group strict diet (e.g. vegan, vegetarian, keto, etc.) * any of the following groups: adults unable to consent, individuals that are not yet adult, pregnant women, prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in metagenomically inferred SCFA production potential | Change observed from baseline sample (Day 0) to second sample (Day 10) | Through metagenomic sequencing analysis, change in relative abundance of short-chain fatty acid producing genes from sequenced timepoint stool samples will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Movement Regularity | Change observed over time from baseline (Day 0) through completion of the study (Day 10) | From a questionnaire that participants will fill out each day of the study, the number of bowel movements, the Bristol stool scale value, and amount of strain experienced during defecation will be assessed. |
Countries
United States
Outcome results
None listed