Recruiting

Multi-Fiber Supplement

Sponsor:

Brown University

Code:

NCT07787026

Conditions

Mixed Fiber Supplementation for Healthy Adults

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prebiotic

Placebo

Study Details

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.

Conditions

Mixed Fiber Supplementation for Healthy Adults

Study ID

NCT07787026

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Mixed Fiber Supplementation Intervention Arm

placebo comparator: Placebo Supplementation Arm

Interventions

Prebiotic

Formulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity

Placebo

Placebo supplementation intervention, with only flavoring agents and no prebiotic fiber

Primary outcome measure

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

Central Contacts and Locations

Locations

Biomedical Center

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

BioMed Facilities Planning and Operations

401-863-1000biomed_facilities@brown.edu

Principal Investigator:

Peter Belenky, PhD

More Information

Sponsor

Brown University

Last update posted

Aug 26, 2026

Last verified

Jul, 2026

Keywords

  • Dietary fiber
  • Prebiotic
  • Stool regularity
  • Randomized controlled trial
  • Healthy adults
  • Microbiome
  • Microbiota
  • Fiber supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-08-26.