A Study to Evaluate the Effects of a Fiber Supplement on Gut Health

NCT07755735 | Completed

• 2 other identifiers: 20719legacy-20719
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloating; Gastrointestinal Symptoms; Gut Health; Irregular Bowel Movements

Outcome Measures

Primary Outcomes (9)

• Change in Overall Gut Health Score

  Mean change in GSRS (Gastrointestinal Symptoms Rating Scale) total score from baseline as assessed via self-reported questionnaire

  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

  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

  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

  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

  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

  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

  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

  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

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (7)

• 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

Study Arms (2)

Active Supplement

EXPERIMENTAL

Dietary Supplement: Active Supplement

Placebo Comparator

PLACEBO COMPARATOR

Dietary Supplement: Placebo Comparator

Interventions

Active Supplement DIETARY_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.

Active Supplement

Placebo Comparator DIETARY_SUPPLEMENT

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.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belli Welli Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89101, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 26, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

US (1)