Clinical trial NCT06023082: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Metabolism
Weight Loss
Energy
Lead sponsor: Gut Health, UAB
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Changes in Body Weight. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Waist Circumference. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Hip Circumference. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Thigh Circumference. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Secondary outcomes:
measure: Changes in Overall Health. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Energy Levels. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Tiredness. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Overall Mood. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Mental Wellbeing. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Ability to Focus. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Frequency of Constipation. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Severity of Constipation. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Bowel Movement Regularity. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Frequency of Gas. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Severity of Gas. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Frequency of Bloating. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Severity of Bloating. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10
measure: Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Number of Bowel Movements Per Week. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
measure: Changes in Frequency of Overeating. [Baseline to Week 12]
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Other outcomes:
measure: Visual Changes in Weight. [Baseline to Week 12]
timeFrame: 12 weeks
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: