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Completed
NCT07755735
A Study to Evaluate the Effects of a Fiber Supplement on Gut Health
Conditions: Gut Health, Bloating, Irregular Bowel Movements, Gastrointestinal Symptoms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Belli Welli Inc.
Location: Citruslabs Las Vegas Nevada
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07755735). StuddyBuddy aggregates publicly available trial information.