A Study to Evaluate the Effects of a Fiber Supplement on Gut Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Overall Gut Health Score
Study Overview
Brief Summary
This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo product, taken twice daily.
Participants will complete questionnaires and provide waist and body composition measurements at Baseline, Week 4, Week 8, and Week 12. The primary outcomes include changes in overall gut health scores, waist circumference, and body composition. Secondary outcomes include participant-perceived effects on bloating, regularity, hydration, energy, and hair, skin, and nail support.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be male or female
- •Be aged 18 or older
- •Experiencing issues regarding all of the following over the past 4 weeks: bloating, irregular bowel movements, and self-perceived poor gut health
- •Generally healthy - does not live with any uncontrolled chronic disease
- •Willing to discontinue any other supplements or herbal remedies that target gut or digestive health
- •Not planning on introducing any products or any new forms of prescription medication or supplements that target gut health for the study duration
- •Willing to maintain current diet, sleep pattern, and activity levels for the duration
- •Resides in the United States
- •Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration
Exclusion Criteria
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries
- •Anyone with any allergies or sensitivities to any of the study product ingredients
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- •Anyone who is vegan and/or does not consume animal products for any reasons
- •Anyone unwilling to follow the study protocol
- •Anyone with a history of substance abuse
Arms & Interventions
Placebo Comparator
Intervention: Placebo Comparator (Dietary Supplement)
Active Supplement
Intervention: Active Supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Overall Gut Health Score
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in GSRS (Gastrointestinal Symptoms Rating Scale) total score from baseline as assessed via self-reported questionnaire
Change in Bowel Movement Quality
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in stool form and consistency as assessed via the Bristol Stool Scale self-reported questionnaire
Change in Self-Reported Hydration
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported hydration as assessed via self-reported questionnaire
Change in Self-Reported Bloating
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported bloating as assessed via self-reported questionnaire
Change in Waist Circumference
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in waist circumference from baseline as assessed via tape measure waist measurement
Change in Body Weight
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in body weight from baseline as assessed via Withings Smart Scale
Change in Muscle Mass
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in muscle mass from baseline as assessed via Withings Smart Scale
Change in Fat Mass
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in fat mass from baseline as assessed via Withings Smart Scale
Change in Visceral Fat Mass
Time Frame: Baseline, Week 4, Week 8, and Week 12
Mean change in visceral fat mass from baseline as assessed via Withings Smart Scale
Secondary Outcomes
- Change in Self-Reported Regularity(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Hydration(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Stool Feeling(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Energy Levels(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Hair(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Skin(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Nail Support(Baseline, Week 4, Week 8, and Week 12)