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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06023082
• Other study ID #: 20349
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2023
• Source: Kilo Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Energy
• Gut Health
• Metabolism
• Weight Loss

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Kilo Health	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut health. [Baseline to Week 12]	Survey-based assessment (0-5 scale) of participant-perceived gut health parameters.	12 weeks
Primary	Changes in metabolism. [Baseline to Week 12]	Survey-based assessment (0-5 scale) of participants' perception of their metabolism.	12 weeks
Secondary	Changes in body weight. [Baseline to Week 12]	Participants will provide body weight measurements using a weighing scales.	12 weeks
Secondary	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
Secondary	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