Assessing the Short-Term Effects of Multi-Fiber Supplementation on Gut Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
in self-reported good health (i.e. no chronic disease, no acute illness)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prebiotic
Dietary supplementFormulated prebiotic supplement designed to be accessible to gut microbiota members and assist with bowel movement regularity
Placebo
Dietary supplementPlacebo supplementation intervention, with only flavoring agents and no prebiotic fiber
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mixed Fiber Supplementation Intervention ArmExperimental treatment 1 intervention
Group B: Placebo Supplementation ArmPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
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.
Time frame
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
Statistically significant shifts in composition, diversity, and functionality
Time frame
Change observed from baseline sample (Day 0) to second sample (Day 10)Sponsors and contacts
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Source ClinicalTrials.gov