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

Study Overview
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Brief Summary
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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.

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

Conditions
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Energy, Gut Health, Metabolism, Weight Loss

Intervention / Treatment
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* Dietary Supplement: Colon Broom Premium supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colon Broom Premium supplement<br>Participants will add 1 scoop (0.23 oz/ 6.47 g) to 12-14 fl oz of water, mix well and drink immediately. Participants will take the supplement 30 -60 minutes before their meal and will then drink an additional glass of water. Participants will be instructed not to take the supplement less than 2 hours before bedtime. The test product may be consumed before breakfast, lunch, or dinner. First week: Start with 1 serving per day Rest of the study period: Increase to 2 servings per day at 2 different times during the day. | Dietary Supplement: Colon Broom Premium supplement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut health. [Baseline to Week 12] | Survey-based assessment (0-5 scale) of participant-perceived gut health parameters. | 12 weeks | 
| Changes in metabolism. [Baseline to Week 12] | Survey-based assessment (0-5 scale) of participants' perception of their metabolism. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight. [Baseline to Week 12] | Participants will provide body weight measurements using a weighing scales. | 12 weeks | 
| Visual changes in weight. [Baseline to Week 12] | Participants will provide before and after pictures for virtual photo grading of visual changes in weight or body composition. | 12 weeks | 
| Changes in tape measurements of the body. [Baseline to Week 12] | Participants will provide tape measurements of their waist, hips, and individual thighs. | 12 weeks |