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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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.
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.
Citruslabs
Las Vegas, Nevada, United States
Change in Overall Gut Health Score
Mean change in GSRS (Gastrointestinal Symptoms Rating Scale) total score from baseline as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Bowel Movement Quality
Mean change in stool form and consistency as assessed via the Bristol Stool Scale self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hydration
Mean change in self-reported hydration as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Bloating
Mean change in self-reported bloating as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Waist Circumference
Mean change in waist circumference from baseline as assessed via tape measure waist measurement
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Body Weight
Mean change in body weight from baseline as assessed via Withings Smart Scale
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Muscle Mass
Mean change in muscle mass from baseline as assessed via Withings Smart Scale
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Fat Mass
Mean change in fat mass from baseline as assessed via Withings Smart Scale
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Visceral Fat Mass
Mean change in visceral fat mass from baseline as assessed via Withings Smart Scale
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Regularity
Mean change in participant-perceived bowel movement regularity as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hydration
Mean change in participant-perceived hydration as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Stool Feeling
Mean change in participant-perceived stool feeling as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Energy Levels
Mean change in participant-perceived energy levels as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hair
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Skin
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Nail Support
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
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