Energy, Gut Health, Metabolism, Weight Loss
Conditions
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.
Interventions
DIETARY_SUPPLEMENTColon 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
Sponsors
Citruslabs
Gut Health, UAB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants will be blinded to the brand and name of the supplement they are taking.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Thigh Circumference. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | Participants will independently measure their thigh circumference in inches. |
| Changes in Body Weight. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | Participants will provide body weight measurements using a weighing scales. |
| Changes in Waist Circumference. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | Participants will independently measure their waist circumference in inches. |
| Changes in Hip Circumference. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | Participants will independently measure their hip circumference in inches. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Overall Mood. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Mental Wellbeing. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Ability to Focus. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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 |
| Changes in Frequency of Constipation. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Severity of Constipation. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Bowel Movement Regularity. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Frequency of Gas. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Frequency of Bloating. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Severity of Bloating. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10 | 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. |
| Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | Participants were asked to report the number of bowel movements they had in the previous week. |
| Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Frequency of Overeating. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Severity of Gas. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Overall Health. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Energy Levels. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
| Changes in Tiredness. [Baseline to Week 12] | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Changes in Weight. [Baseline to Week 12] | 12 weeks | At baseline and endline, participants provided three photos from their chin down to their knees at the following angles: front-facing, side profile, and facing backward. These photos were not analyzed or included in the data analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colon Broom Premium Supplement 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.
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 | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Side effects | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Colon Broom Premium Supplement |
|---|---|
| Age, Continuous | 41.69 years STANDARD_DEVIATION 6.97 |
| Body Mass Index (BMI) | 32.1535 kg/m2 STANDARD_DEVIATION 7.220633559 |
| Bodyweight | 198.0341667 Pounds (llbs) STANDARD_DEVIATION 43.11105358 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Mixed race | 7 Participants |
| Race/Ethnicity, Customized White | 87 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 5 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Baseline | 194.81 Pounds (lbs) | Standard Deviation 39.48 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 1 | 194.35 Pounds (lbs) | Standard Deviation 39.32 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 2 | 194.17 Pounds (lbs) | Standard Deviation 39.64 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 3 | 193.68 Pounds (lbs) | Standard Deviation 40.03 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 4 | 192.84 Pounds (lbs) | Standard Deviation 40.18 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 6 | 192.81 Pounds (lbs) | Standard Deviation 39.43 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 8 | 192.18 Pounds (lbs) | Standard Deviation 39.76 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 10 | 191.19 Pounds (lbs) | Standard Deviation 39.65 |
| Colon Broom Premium Supplement | Changes in Body Weight. [Baseline to Week 12] | Week 12 | 189.86 Pounds (lbs) | Standard Deviation 41.21 |
p-value: <0.0001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 8 | 42.80 Inches | Standard Deviation 5.98 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 6 | 43.06 Inches | Standard Deviation 6.02 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Baseline | 44.24 Inches | Standard Deviation 6.34 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 1 | 43.84 Inches | Standard Deviation 5.85 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 2 | 43.32 Inches | Standard Deviation 5.64 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 3 | 43.56 Inches | Standard Deviation 5.79 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 4 | 43.21 Inches | Standard Deviation 5.71 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 10 | 42.45 Inches | Standard Deviation 6.61 |
| Colon Broom Premium Supplement | Changes in Hip Circumference. [Baseline to Week 12] | Week 12 | 42.21 Inches | Standard Deviation 6.15 |
p-value: <0.0001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Baseline | 25.12 Inches | Standard Deviation 4.63 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 1 | 24.84 Inches | Standard Deviation 4.36 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 2 | 24.79 Inches | Standard Deviation 4.03 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 3 | 24.36 Inches | Standard Deviation 3.31 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 4 | 24.68 Inches | Standard Deviation 4.12 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 6 | 24.37 Inches | Standard Deviation 4.19 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 8 | 24.13 Inches | Standard Deviation 3.91 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 10 | 23.80 Inches | Standard Deviation 4.12 |
| Colon Broom Premium Supplement | Changes in Thigh Circumference. [Baseline to Week 12] | Week 12 | 24.03 Inches | Standard Deviation 3.94 |
p-value: <0.0001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Baseline | 38.43 Inches | Standard Deviation 6.3 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 1 | 38.74 Inches | Standard Deviation 5.76 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 2 | 38.35 Inches | Standard Deviation 5.61 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 3 | 38.44 Inches | Standard Deviation 5.97 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 4 | 37.89 Inches | Standard Deviation 5.87 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 6 | 38.14 Inches | Standard Deviation 5.46 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 8 | 37.38 Inches | Standard Deviation 6.17 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 10 | 37.36 Inches | Standard Deviation 6.1 |
| Colon Broom Premium Supplement | Changes in Waist Circumference. [Baseline to Week 12] | Week 12 | 37.05 Inches | Standard Deviation 5.82 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Baseline | 3.11 score on a scale | Standard Deviation 0.93 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 1 | 3.55 score on a scale | Standard Deviation 0.79 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 2 | 3.65 score on a scale | Standard Deviation 0.79 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 3 | 3.68 score on a scale | Standard Deviation 0.72 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 4 | 3.66 score on a scale | Standard Deviation 0.86 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 6 | 3.63 score on a scale | Standard Deviation 0.92 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 8 | 3.59 score on a scale | Standard Deviation 0.85 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 10 | 3.69 score on a scale | Standard Deviation 0.82 |
| Colon Broom Premium Supplement | Changes in Ability to Focus. [Baseline to Week 12] | Week 12 | 3.77 score on a scale | Standard Deviation 0.89 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Baseline | 2.61 score on a scale | Standard Deviation 1.08 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 1 | 3.04 score on a scale | Standard Deviation 1.15 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 2 | 3.08 score on a scale | Standard Deviation 1.07 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 3 | 3.23 score on a scale | Standard Deviation 1.17 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 4 | 3.11 score on a scale | Standard Deviation 1.1 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 6 | 3.13 score on a scale | Standard Deviation 1.18 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 8 | 3.05 score on a scale | Standard Deviation 1.16 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 10 | 3.15 score on a scale | Standard Deviation 1.14 |
| Colon Broom Premium Supplement | Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] | Week 12 | 3.21 score on a scale | Standard Deviation 1.21 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Baseline | 3.94 score on a scale | Standard Deviation 0.84 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 1 | 4.34 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 2 | 4.28 score on a scale | Standard Deviation 0.75 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 3 | 4.39 score on a scale | Standard Deviation 0.67 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 4 | 4.34 score on a scale | Standard Deviation 0.88 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 6 | 4.46 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 8 | 4.41 score on a scale | Standard Deviation 0.67 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 10 | 4.15 score on a scale | Standard Deviation 1.03 |
| Colon Broom Premium Supplement | Changes in Bowel Movement Regularity. [Baseline to Week 12] | Week 12 | 4.31 score on a scale | Standard Deviation 0.9 |
p-value: 0.001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Baseline | 3.86 score on a scale | Standard Deviation 1.11 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 1 | 5.27 score on a scale | Standard Deviation 1.14 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 2 | 5.52 score on a scale | Standard Deviation 1.14 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 3 | 5.64 score on a scale | Standard Deviation 1.26 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 4 | 5.58 score on a scale | Standard Deviation 1.3 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 6 | 5.71 score on a scale | Standard Deviation 1.26 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 8 | 5.82 score on a scale | Standard Deviation 1.11 |
| Colon Broom Premium Supplement | Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] | Week 10 | 5.72 score on a scale | Standard Deviation 1.3 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Baseline | 2.47 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 1 | 3.01 score on a scale | Standard Deviation 0.64 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 2 | 3.05 score on a scale | Standard Deviation 0.65 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 3 | 3.11 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 4 | 3.15 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 6 | 3.16 score on a scale | Standard Deviation 0.81 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 8 | 3.13 score on a scale | Standard Deviation 0.91 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 10 | 3.18 score on a scale | Standard Deviation 0.77 |
| Colon Broom Premium Supplement | Changes in Energy Levels. [Baseline to Week 12] | Week 12 | 3.22 score on a scale | Standard Deviation 0.87 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Baseline | 2.13 score on a scale | Standard Deviation 0.94 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 1 | 2.71 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 2 | 3.16 score on a scale | Standard Deviation 1.23 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 3 | 3.22 score on a scale | Standard Deviation 1.22 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 4 | 3.41 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 6 | 3.52 score on a scale | Standard Deviation 1.21 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 8 | 3.50 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | week 10 | 3.66 score on a scale | Standard Deviation 1.26 |
| Colon Broom Premium Supplement | Changes in Frequency of Bloating. [Baseline to Week 12] | Week 12 | 3.66 score on a scale | Standard Deviation 1.2 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Baseline | 3.01 score on a scale | Standard Deviation 1.02 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 1 | 3.64 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 2 | 3.94 score on a scale | Standard Deviation 1.03 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 3 | 3.95 score on a scale | Standard Deviation 1.16 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 4 | 4.01 score on a scale | Standard Deviation 1.1 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 6 | 3.98 score on a scale | Standard Deviation 1.19 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 8 | 3.91 score on a scale | Standard Deviation 1.18 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 10 | 3.99 score on a scale | Standard Deviation 1.14 |
| Colon Broom Premium Supplement | Changes in Frequency of Constipation. [Baseline to Week 12] | Week 12 | 4.10 score on a scale | Standard Deviation 1.12 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Baseline | 2.54 score on a scale | Standard Deviation 1.1 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 1 | 3.38 score on a scale | Standard Deviation 1.24 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 2 | 3.69 score on a scale | Standard Deviation 1.24 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 3 | 3.71 score on a scale | Standard Deviation 1.17 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 4 | 3.71 score on a scale | Standard Deviation 1.09 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 6 | 3.78 score on a scale | Standard Deviation 1.17 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 8 | 3.81 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 10 | 3.80 score on a scale | Standard Deviation 1.07 |
| Colon Broom Premium Supplement | Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] | Week 12 | 3.86 score on a scale | Standard Deviation 1.16 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Baseline | 1.71 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 1 | 2.32 score on a scale | Standard Deviation 1.1 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 2 | 2.63 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 3 | 2.73 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 4 | 2.93 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 6 | 2.93 score on a scale | Standard Deviation 1.27 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 8 | 3.00 score on a scale | Standard Deviation 1.24 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 10 | 3.11 score on a scale | Standard Deviation 1.26 |
| Colon Broom Premium Supplement | Changes in Frequency of Gas. [Baseline to Week 12] | Week 12 | 3.16 score on a scale | Standard Deviation 1.25 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Baseline | 2.47 score on a scale | Standard Deviation 1.14 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 1 | 3.35 score on a scale | Standard Deviation 1.19 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 2 | 3.60 score on a scale | Standard Deviation 1.13 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 3 | 3.53 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 4 | 3.71 score on a scale | Standard Deviation 1.15 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 6 | 3.64 score on a scale | Standard Deviation 1.24 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 8 | 3.70 score on a scale | Standard Deviation 1.22 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 10 | 3.74 score on a scale | Standard Deviation 1.2 |
| Colon Broom Premium Supplement | Changes in Frequency of Overeating. [Baseline to Week 12] | Week 12 | 3.75 score on a scale | Standard Deviation 1.16 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Baseline | 3.47 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 1 | 3.81 score on a scale | Standard Deviation 0.62 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 2 | 3.81 score on a scale | Standard Deviation 0.6 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 3 | 3.78 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 4 | 3.78 score on a scale | Standard Deviation 0.71 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 6 | 3.80 score on a scale | Standard Deviation 0.8 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 8 | 3.67 score on a scale | Standard Deviation 0.79 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 10 | 3.82 score on a scale | Standard Deviation 0.73 |
| Colon Broom Premium Supplement | Changes in Mental Wellbeing. [Baseline to Week 12] | Week 12 | 3.84 score on a scale | Standard Deviation 0.8 |
p-value: 0.0016ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Baseline | 5.63 Number of bowel movements per week | Standard Deviation 3.96 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 1 | 7.13 Number of bowel movements per week | Standard Deviation 4.15 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 2 | 7.19 Number of bowel movements per week | Standard Deviation 4.51 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 3 | 7.26 Number of bowel movements per week | Standard Deviation 4.05 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 4 | 7.75 Number of bowel movements per week | Standard Deviation 4.71 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 6 | 7.59 Number of bowel movements per week | Standard Deviation 4.52 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 8 | 7.21 Number of bowel movements per week | Standard Deviation 4.68 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 10 | 7.41 Number of bowel movements per week | Standard Deviation 4.48 |
| Colon Broom Premium Supplement | Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] | Week 12 | 7.21 Number of bowel movements per week | Standard Deviation 4.1 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Baseline | 3.75 score on a scale | Standard Deviation 0.77 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 1 | 3.86 score on a scale | Standard Deviation 0.66 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 2 | 3.85 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 3 | 3.90 score on a scale | Standard Deviation 0.72 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 4 | 3.89 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 6 | 3.89 score on a scale | Standard Deviation 0.65 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 8 | 3.74 score on a scale | Standard Deviation 0.81 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 10 | 3.95 score on a scale | Standard Deviation 0.67 |
| Colon Broom Premium Supplement | Changes in Overall Health. [Baseline to Week 12] | Week 12 | 3.91 score on a scale | Standard Deviation 0.85 |
p-value: 0.4907ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Baseline | 3.30 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 1 | 3.75 score on a scale | Standard Deviation 0.62 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 2 | 3.74 score on a scale | Standard Deviation 0.67 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 3 | 3.69 score on a scale | Standard Deviation 0.65 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 4 | 3.75 score on a scale | Standard Deviation 0.68 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 6 | 3.71 score on a scale | Standard Deviation 0.74 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 8 | 3.69 score on a scale | Standard Deviation 0.81 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 10 | 3.77 score on a scale | Standard Deviation 0.77 |
| Colon Broom Premium Supplement | Changes in Overall Mood. [Baseline to Week 12] | Week 12 | 3.80 score on a scale | Standard Deviation 0.75 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Baseline | 2.75 score on a scale | Standard Deviation 0.88 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 1 | 3.47 score on a scale | Standard Deviation 0.95 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 2 | 3.74 score on a scale | Standard Deviation 0.92 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 3 | 3.73 score on a scale | Standard Deviation 0.99 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 4 | 3.79 score on a scale | Standard Deviation 1.03 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 6 | 3.97 score on a scale | Standard Deviation 0.93 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 8 | 3.84 score on a scale | Standard Deviation 0.96 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 10 | 3.92 score on a scale | Standard Deviation 1.02 |
| Colon Broom Premium Supplement | Changes in Severity of Bloating. [Baseline to Week 12] | Week 12 | 4.03 score on a scale | Standard Deviation 0.86 |
Comparison: Baseline to Week 12 comparison.p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Baseline | 3.34 score on a scale | Standard Deviation 0.9 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 1 | 3.70 score on a scale | Standard Deviation 0.82 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 2 | 3.89 score on a scale | Standard Deviation 0.87 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 3 | 3.96 score on a scale | Standard Deviation 0.92 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 4 | 3.97 score on a scale | Standard Deviation 0.94 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 6 | 4.06 score on a scale | Standard Deviation 0.91 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 8 | 3.81 score on a scale | Standard Deviation 0.98 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 10 | 3.88 score on a scale | Standard Deviation 0.93 |
| Colon Broom Premium Supplement | Changes in Severity of Constipation. [Baseline to Week 12] | Week 12 | 4.34 score on a scale | Standard Deviation 0.87 |
p-value: 0.0002ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Baseline | 2.76 score on a scale | Standard Deviation 0.69 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 1 | 3.35 score on a scale | Standard Deviation 0.88 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 2 | 3.58 score on a scale | Standard Deviation 0.89 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 3 | 3.64 score on a scale | Standard Deviation 0.95 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 4 | 3.82 score on a scale | Standard Deviation 0.86 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 6 | 3.84 score on a scale | Standard Deviation 0.9 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 8 | 3.74 score on a scale | Standard Deviation 0.97 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 10 | 3.82 score on a scale | Standard Deviation 0.92 |
| Colon Broom Premium Supplement | Changes in Severity of Gas. [Baseline to Week 12] | Week 12 | 3.92 score on a scale | Standard Deviation 0.91 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Baseline | 1.94 score on a scale | Standard Deviation 0.97 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 1 | 2.77 score on a scale | Standard Deviation 1.23 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 2 | 2.95 score on a scale | Standard Deviation 1.17 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 3 | 3.16 score on a scale | Standard Deviation 1.13 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 4 | 3.27 score on a scale | Standard Deviation 1.15 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 6 | 3.23 score on a scale | Standard Deviation 1.24 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 8 | 3.28 score on a scale | Standard Deviation 1.23 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 10 | 3.42 score on a scale | Standard Deviation 1.25 |
| Colon Broom Premium Supplement | Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] | Week 12 | 3.47 score on a scale | Standard Deviation 1.24 |
p-value: <0.0001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Baseline | 1.80 score on a scale | Standard Deviation 0.72 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 1 | 2.52 score on a scale | Standard Deviation 0.98 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 2 | 2.52 score on a scale | Standard Deviation 0.99 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 3 | 2.75 score on a scale | Standard Deviation 1.05 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 4 | 2.67 score on a scale | Standard Deviation 1.12 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 6 | 2.71 score on a scale | Standard Deviation 1.08 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 8 | 2.69 score on a scale | Standard Deviation 1.11 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 10 | 2.70 score on a scale | Standard Deviation 1.18 |
| Colon Broom Premium Supplement | Changes in Tiredness. [Baseline to Week 12] | Week 12 | 2.90 score on a scale | Standard Deviation 1.07 |
p-value: <0.0001ANOVA
Other Pre-specified
Visual Changes in Weight. [Baseline to Week 12]
At baseline and endline, participants provided three photos from their chin down to their knees at the following angles: front-facing, side profile, and facing backward. These photos were not analyzed or included in the data analysis.
Time frame: 12 weeks