Mixed Fiber Supplementation for Healthy AdultsNCT07787026
Assessing the Short-Term Effects of Multi-Fiber Supplementation on Gut Health
A study testing Prebiotic in people with Mixed Fiber Supplementation for Healthy Adults, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mixed Fiber Supplementation for Healthy Adults
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in self-reported good health (i.e. no chronic disease, no acute illness)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biomedical Center
Providence, Rhode Island, 02912
BioMed Facilities Planning and Operations, 401-863-1000, biomed_facilities@brown.edu
Peter Belenky, PhD
About this study
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.
- Being tested
- Prebiotic, Placebo
- Keywords
- Dietary fiber, Prebiotic, Stool regularity, Randomized controlled trial, Healthy adults, Microbiome, Microbiota, Fiber supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Formulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity
PlaceboDietary supplement
Placebo supplementation intervention, with only flavoring agents and no prebiotic fiber
| Study group | Role | What they receive |
|---|---|---|
| Mixed Fiber Supplementation Intervention Arm | Experimental | Not described Receives: Dietary Supplement: Prebiotic |
| Placebo Supplementation Arm | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change observed from baseline sample (Day 0) to second sample (Day 10)
Secondary outcomes (1)
Bowel Movement Regularity
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.
Measured: Change observed over time from baseline (Day 0) through completion of the study (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Fiber Supplementation for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787026
- Sponsor's protocol ID
- STUDY00000994
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Short-Term Effects of Multi-Fiber Supplementation on Gut Health
- ClinicalTrials.gov ID
- NCT07787026
- Acronym / sponsor ID
- STUDY00000994
- Keywords
- Dietary fiber, Prebiotic, Stool regularity, Randomized controlled trial, Healthy adults, Microbiome, Microbiota, Fiber supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed Fiber Supplementation Intervention Arm | Experimental | Dietary Supplement: Prebiotic |
| Placebo Supplementation Arm | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in self-reported good health (i.e. no chronic disease, no acute illness)
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticFormulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity | Dietary supplement | Mixed Fiber Supplementation Intervention Arm |
| PlaceboPlacebo supplementation intervention, with only flavoring agents and no prebiotic fiber | Dietary supplement | Placebo Supplementation Arm |
Primary outcome
Change in metagenomically inferred SCFA production potential
Time frame: 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.
1 secondary outcome
Bowel Movement Regularity
Time frame: Change observed over time from baseline (Day 0) through completion of the study (Day 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Mixed Fiber Supplementation for Healthy Adults, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metagenomically inferred SCFA production potential (time frame: Change observed from baseline sample (Day 0) to second sample (Day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.