Assessing the Short-Term Effects of Multi-Fiber Supplementation on Gut Health

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT07787026
Status
Recruiting

Conditions

  • Mixed Fiber Supplementation for Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Prebiotic — DIETARY_SUPPLEMENT
    Formulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity
  • Placebo — DIETARY_SUPPLEMENT
    Placebo supplementation intervention, with only flavoring agents and no prebiotic fiber

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mixed Fiber Supplementation Intervention Arm
  • Placebo Comparator: Placebo Supplementation Arm

Primary Outcome Measure

Change in metagenomically inferred SCFA production potential [ Time Frame: Change observed from baseline sample (Day 0) to second sample (Day 10) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Biomedical CenterProvidenceRhode Island02912
BioMed Facilities Planning and Operations
401-863-1000
Peter Belenky, PhD (PRINCIPAL_INVESTIGATOR)

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