Skip to main content
OpenTrials
Completed

NCT Number: NCT06023082

A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management

This study will evaluate the efficacy of Colon Broom Premium on gut health, metabolism, weight management, and energy levels. The study will be conducted as a virtual single-group trial in which all 120 participants will use the test product. This study will last 12 weeks, and participants will take the product daily. Participants will complete study-specific questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12. Participants will also provide body weight measurements and body circumference measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12.

Before & after photographs will be provided at Baseline and Week 12.

The Colon Broom Premium supplement contains psyllium seed husk powder, L-carnitine tartrate, CapsimaxⓇ cayenne fruit extract, chromium (as chromium picolinate), vitamin B6 (as pyridoxine HCl), vitamin B12 (as cyanocobalamin), and Iron.

The study Sponsor and product name will remain anonymous to participants throughout the trial. The Sponsor name or product name will not be included in any participant-facing documentation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gut Health Body Weight Body Weight Changes Energy Metabolism Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female between ages 30-50
  • Have a BMI of 25 or more
  • Have self-reported issues with gas, bloating, constipation, heartburn/acid reflux, abdominal pain, or digestion at least three times per week
  • Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study
  • Be generally healthy - do not live with any uncontrolled chronic disease

Exclusion criteria

  • Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Anyone who is currently undergoing, or planning to to undergo any gut or weight-related procedures in the next 12 week.
  • Anyone with a history of severe allergic reactions including but not limited to psyllium seed husk powder and strawberries
  • Anyone taking any prescription medications targeting the gut
  • Anyone taking any supplements targeting the gut in the past month
  • Use of antibiotics in the past 3 months
  • Women who are pregnant, breastfeeding, or attempting to become pregnant
  • Anyone unwilling to follow the study protocol
  • Anyone following any particular dietary regime, such as a ketogenic diet or intermittent fasting.
  • Anyone who has had bariatric surgery in the past 6 months
  • Anyone who has chronic constipation
  • Anyone who has Irritable Bowel Disease (IBD)
  • Anyone diagnosed with severe digestive issues

Treatment and study plan

Colon Broom Premium supplement

Dietary Supplement

The product contains the following ingredients:

Psyllium Seed Husk Powder L-Carnitine Tartrate Capsimax® Cayenne Fruit Extract Chromium (as Chromium Picolinate) Vitamin B6 (as Pyridoxine HCl) Vitamin B12 (as Cyanocobalamin) Iron

Primary outcomes

  1. Changes in Body Weight. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Participants will provide body weight measurements using a weighing scales.

  2. Changes in Waist Circumference. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Participants will independently measure their waist circumference in inches.

  3. Changes in Hip Circumference. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Participants will independently measure their hip circumference in inches.

  4. Changes in Thigh Circumference. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Participants will independently measure their thigh circumference in inches.

Secondary outcomes

  1. Changes in Overall Health. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in overall health. On the scale, 1=worst response, and 5= the most favorable response.

  2. Changes in Energy Levels. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in energy levels. On the scale, 1=worst response, and 5= the most favorable response.

  3. Changes in Tiredness. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in tiredness. On the scale, 1=worst response, and 5= the most favorable response.

  4. Changes in Overall Mood. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in overall mood. On the scale, 1=worst response, and 5= the most favorable response.

  5. Changes in Mental Wellbeing. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in mental wellbeing. On the scale, 1=worst response, and 5= the most favorable response.

  6. Changes in Ability to Focus. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-perceived changes in ability to focus. On the scale, 1=worst response, and 5= the most favorable response.

  7. Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in the amount of daily leisure time spent active. On the scale, 1=least amount of time, and 5= the most amount of time. 1= 0-15min; 2= 15-30min; 3= 30-60min; 4=60-90 min; 5=more than 90min

  8. Changes in Frequency of Constipation. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 1= Never; 2= Less than once per week; 3= Once per week; 4= 2-5 times per week; 5= More than 5 times per week.

  9. Changes in Severity of Constipation. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of constipation. On the scale, 1=worst response, and 5= the most favorable response. 1= Not noticeable; 2= Barely noticeable; 3= Moderate; 4= Distracting ; 5= Severe.

  10. Changes in Bowel Movement Regularity. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in bowel movement regularity. On the scale, 1=worst response, and 5= the most favorable response. 1= Never; 2= Less than once per week; 3= Once per week; 4= 2-5 times per week; 5= More than 5 times per week.

  11. Changes in Frequency of Gas. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of gas. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.

  12. Changes in Severity of Gas. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of gas. On the scale, 1=worst response, and 5= the most favorable response. 5= Not noticeable; 4= Barely noticeable; 3= Moderate; 2= Distracting; 1= Severe.

  13. Changes in Frequency of Bloating. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of bloating. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.

  14. Changes in Severity of Bloating. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of bloating. On the scale, 1=worst response, and 5= the most favorable response. 5= Not noticeable; 4= Barely noticeable; 3= Moderate; 2= Distracting; 1= Severe.

  15. Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10

    Survey-based assessment on a 7-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 7= the most favorable response. 7= No discomfort at all; 6= Minor discomfort; 5= Mild discomfort; 4= Moderate discomfort; 3= Moderately severe discomfort; 2= Severe discomfort; 1= Very severe discomfort.

  16. Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-report changes in frequency of feeling hungry even after eating a meal. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.

  17. Changes in Number of Bowel Movements Per Week. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Participants were asked to report the number of bowel movements they had in the previous week.

  18. Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.

  19. Changes in Frequency of Overeating. [Baseline to Week 12]

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12

    Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.

Other outcomes

  1. Visual Changes in Weight. [Baseline to Week 12]

    Time frame: 12 weeks

    At baseline and endline, participants provided three photos from their chin down to their knees at the following angles: front-facing, side profile, and facing backward. These photos were not analyzed or included in the data analysis.

Sponsors and collaborators

Lead sponsor

Gut Health, UAB

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Jan 13, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.