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

NCT ID: NCT06023082

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2023-11-26

Brief Summary

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.

Conditions

Gut Health; Metabolism; Weight Loss; Energy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Colon Broom Premium supplement

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.

Group Type: EXPERIMENTAL

Colon Broom Premium supplement

Intervention Type: 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

Interventions

Colon Broom Premium 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Gut Health, UAB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20349

Identifier Type: -

Identifier Source: org_study_id