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Completed

NCT Number: NCT07755735

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

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.

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Key information

Conditions

Gut Health Bloating Gastrointestinal Symptoms Irregular Bowel Movements

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  1. Change in Self-Reported Regularity

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived bowel movement regularity as assessed via self-reported questionnaire

  2. Change in Self-Reported Hydration

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived hydration as assessed via self-reported questionnaire

  3. Change in Self-Reported Stool Feeling

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived stool feeling as assessed via self-reported questionnaire

  4. Change in Self-Reported Energy Levels

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived energy levels as assessed via self-reported questionnaire

  5. Change in Self-Reported Hair

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire

  6. Change in Self-Reported Skin

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire

  7. Change in Self-Reported Nail Support

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire

Sponsors and collaborators

Lead sponsor

Belli Welli Inc.

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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