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

NCT06023082 | Completed Results

• 1 other identifier: 20349
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

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

  Participants will provide body weight measurements using a weighing scales.

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

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

  Participants will independently measure their waist circumference in inches.

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

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

  Participants will independently measure their hip circumference in inches.

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

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

  Participants will independently measure their thigh circumference in inches.

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

Secondary Outcomes (19)

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

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

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

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

• Changes in Tiredness. [Baseline to Week 12]

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

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

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

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

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

Other Outcomes (1)

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

  12 weeks

Study Arms (1)

Colon Broom Premium supplement

EXPERIMENTAL

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

Interventions

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

Colon Broom Premium supplement

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gut Health, UAB: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Reliance on self-reported data.

Results Point of Contact

• Title: Patrick Renner
• Organization: Citruslabs

hello@citruslabs.com

(805) 292-0714

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blinded to the brand and name of the supplement they are taking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: July 26, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 26, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11

Locations

US (1)