NCT07787026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026Aug 2029

Study Start

First participant enrolled

August 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 26, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

August 20, 2026

Last Update Submit

August 24, 2026

Conditions

Mixed Fiber Supplementation for Healthy Adults

Keywords

Dietary fiberPrebioticStool regularityRandomized controlled trialHealthy adultsMicrobiomeMicrobiotaFiber supplementation

Outcome Measures

Primary Outcomes (1)

  • Change in metagenomically inferred SCFA production potential

    Through metagenomic sequencing analysis, change in relative abundance of short-chain fatty acid producing genes from sequenced timepoint stool samples will be assessed.

    Change observed from baseline sample (Day 0) to second sample (Day 10)

Secondary Outcomes (1)

  • Bowel Movement Regularity

    Change observed over time from baseline (Day 0) through completion of the study (Day 10)

Other Outcomes (1)

  • Observed changes in stool microbiome composition as profiled by metagenomic sequencing analysis

    Change observed from baseline sample (Day 0) to second sample (Day 10)

Study Arms (2)

Mixed Fiber Supplementation Intervention Arm

EXPERIMENTAL
Dietary Supplement: Prebiotic

Placebo Supplementation Arm

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

PrebioticDIETARY_SUPPLEMENT

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

Mixed Fiber Supplementation Intervention Arm
PlaceboDIETARY_SUPPLEMENT

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

Placebo Supplementation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in self-reported good health (i.e. no chronic disease, no acute illness)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Center

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 26, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

August 26, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)