Bloating, Gastrointestinal Symptoms, Gut Health, Irregular Bowel Movements
Conditions
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.
Interventions
DIETARY_SUPPLEMENTActive Supplement
Participants receive BelliWelli Daily Fiber + Probiotics supplement containing Collagen Peptides (Bovine) (2 g), Niacin as Niacinamide (7.5 mg), Magnesium as Magnesium Citrate (75 mg), Sodium as Sea Salt (75 mg), Potassium as Potassium Chloride (100 mg), Bacillus coagulans MTCC 5856 (10 mg / 1 billion CFU), and Acacia Fiber (4.0 g), consumed twice per day for 12 weeks.
DIETARY_SUPPLEMENTPlacebo Comparator
Participants receive a taste- and appearance-matched placebo product containing Maltodextrin, Organic Cane Sugar, Natural Flavors, Citric Acid, Malic Acid, Silicon Dioxide, Stevia Leaf Extract, Beet Juice (color), and Fruit and Vegetable Juice (color), consumed twice per day for 12 weeks.
Sponsors
Belli Welli Inc.
Citruslabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Gut Health Score | 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 | 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 | 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 | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported bloating as assessed via self-reported questionnaire |
| Change in Waist Circumference | 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 | 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 | 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 | 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 | Baseline, Week 4, Week 8, and Week 12 | Mean change in visceral fat mass from baseline as assessed via Withings Smart Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Regularity | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived bowel movement regularity as assessed via self-reported questionnaire |
| Change in Self-Reported Hydration | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived hydration as assessed via self-reported questionnaire |
| Change in Self-Reported Stool Feeling | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived stool feeling as assessed via self-reported questionnaire |
| Change in Self-Reported Energy Levels | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived energy levels as assessed via self-reported questionnaire |
| Change in Self-Reported Hair | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire |
| Change in Self-Reported Skin | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire |
| Change in Self-Reported Nail Support | Baseline, Week 4, Week 8, and Week 12 | Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire |
Countries
United States
Outcome results
None listed