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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06023082
Other study ID # 20349
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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