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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

Primary Purpose

Gut Health, Metabolism, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colon Broom Premium supplement
Sponsored by
Kilo Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gut Health

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colon Broom Premium supplement

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in body weight. [Baseline to Week 12]
Participants will provide body weight measurements using a weighing scales.
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.
Changes in tape measurements of the body. [Baseline to Week 12]
Participants will provide tape measurements of their waist, hips, and individual thighs.

Full Information

First Posted
August 28, 2023
Last Updated
August 28, 2023
Sponsor
Kilo Health
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT06023082
Brief Title
A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kilo Health
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Health, Metabolism, Weight Loss, Energy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants will be blinded to the brand and name of the supplement they are taking.
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colon Broom Premium supplement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Colon Broom Premium supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in gut health. [Baseline to Week 12]
Description
Survey-based assessment (0-5 scale) of participant-perceived gut health parameters.
Time Frame
12 weeks
Title
Changes in metabolism. [Baseline to Week 12]
Description
Survey-based assessment (0-5 scale) of participants' perception of their metabolism.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight. [Baseline to Week 12]
Description
Participants will provide body weight measurements using a weighing scales.
Time Frame
12 weeks
Title
Visual changes in weight. [Baseline to Week 12]
Description
Participants will provide "before" and "after" pictures for virtual photo grading of visual changes in weight or body composition.
Time Frame
12 weeks
Title
Changes in tape measurements of the body. [Baseline to Week 12]
Description
Participants will provide tape measurements of their waist, hips, and individual thighs.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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