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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
120
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
Citruslabs
Santa Monica, California, United States
Changes in Body Weight. [Baseline to Week 12]
Participants will provide body weight measurements using a weighing scales.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Overall Health. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in overall health. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: 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]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in energy levels. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: 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]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in tiredness. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: 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]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in overall mood. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: 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]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in mental wellbeing. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Ability to Focus. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-perceived changes in ability to focus. On the scale, 1=worst response, and 5= the most favorable response.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in the amount of daily leisure time spent active. On the scale, 1=least amount of time, and 5= the most amount of time. 1= 0-15min; 2= 15-30min; 3= 30-60min; 4=60-90 min; 5=more than 90min
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Frequency of Constipation. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 1= Never; 2= Less than once per week; 3= Once per week; 4= 2-5 times per week; 5= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Severity of Constipation. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of constipation. On the scale, 1=worst response, and 5= the most favorable response. 1= Not noticeable; 2= Barely noticeable; 3= Moderate; 4= Distracting ; 5= Severe.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in bowel movement regularity. On the scale, 1=worst response, and 5= the most favorable response. 1= Never; 2= Less than once per week; 3= Once per week; 4= 2-5 times per week; 5= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Frequency of Gas. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of gas. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Severity of Gas. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of gas. On the scale, 1=worst response, and 5= the most favorable response. 5= Not noticeable; 4= Barely noticeable; 3= Moderate; 2= Distracting; 1= Severe.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Frequency of Bloating. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of bloating. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Severity of Bloating. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in severity of bloating. On the scale, 1=worst response, and 5= the most favorable response. 5= Not noticeable; 4= Barely noticeable; 3= Moderate; 2= Distracting; 1= Severe.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Survey-based assessment on a 7-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 7= the most favorable response. 7= No discomfort at all; 6= Minor discomfort; 5= Mild discomfort; 4= Moderate discomfort; 3= Moderately severe discomfort; 2= Severe discomfort; 1= Very severe discomfort.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10
Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-report changes in frequency of feeling hungry even after eating a meal. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Number of Bowel Movements Per Week. [Baseline to Week 12]
Participants were asked to report the number of bowel movements they had in the previous week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Changes in Frequency of Overeating. [Baseline to Week 12]
Survey-based assessment on a 5-point Likert scale of participant-reported changes in frequency of constipation. On the scale, 1=worst response, and 5= the most favorable response. 5= Never; 4= Less than once per week; 3= Once per week; 2= 2-5 times per week; 1= More than 5 times per week.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
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