| Primary | Changes in Body Weight. [Baseline to Week 12] | Participants will provide body weight measurements using a weighing scales. | | Posted | | Mean | Standard Deviation | Pounds (lbs) | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
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| OG000 | 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 |
| | | Title | Denominators | Categories |
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| Baseline | | | | Week 1 | | | | Week 2 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANOVA | | <0.0001 | Baseline to Week 12 comparison. | | | | | | | | | | | | | Other | | |
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| Primary | Changes in Waist Circumference. [Baseline to Week 12] | Participants will independently measure their waist circumference in inches. | | Posted | | Mean | Standard Deviation | Inches | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Primary | Changes in Hip Circumference. [Baseline to Week 12] | Participants will independently measure their hip circumference in inches. | | Posted | | Mean | Standard Deviation | Inches | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Primary | Changes in Thigh Circumference. [Baseline to Week 12] | Participants will independently measure their thigh circumference in inches. | | Posted | | Mean | Standard Deviation | Inches | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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 | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | Number of bowel movements per week | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| 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. | | Not Posted | | | | | | 12 weeks | | Participants | | | | |