Trial Outcomes & Findings for A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management (NCT NCT06023082)
NCT ID: NCT06023082
Last Updated: 2025-01-13
Results Overview
Participants will provide body weight measurements using a weighing scales.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Side effects
|
5
|
Baseline Characteristics
A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management
Baseline characteristics by cohort
| Measure |
Colon Broom Premium Supplement
n=120 Participants
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
|
|---|---|
|
Age, Continuous
|
41.69 years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
7 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.1535 kg/m2
STANDARD_DEVIATION 7.220633559 • n=5 Participants
|
|
Bodyweight
|
198.0341667 Pounds (llbs)
STANDARD_DEVIATION 43.11105358 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Participants will provide body weight measurements using a weighing scales.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Body Weight. [Baseline to Week 12]
Baseline
|
194.81 Pounds (lbs)
Standard Deviation 39.48
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 1
|
194.35 Pounds (lbs)
Standard Deviation 39.32
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 2
|
194.17 Pounds (lbs)
Standard Deviation 39.64
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 3
|
193.68 Pounds (lbs)
Standard Deviation 40.03
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 4
|
192.84 Pounds (lbs)
Standard Deviation 40.18
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 6
|
192.81 Pounds (lbs)
Standard Deviation 39.43
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 8
|
192.18 Pounds (lbs)
Standard Deviation 39.76
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 10
|
191.19 Pounds (lbs)
Standard Deviation 39.65
|
|
Changes in Body Weight. [Baseline to Week 12]
Week 12
|
189.86 Pounds (lbs)
Standard Deviation 41.21
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Participants will independently measure their waist circumference in inches.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Waist Circumference. [Baseline to Week 12]
Baseline
|
38.43 Inches
Standard Deviation 6.30
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 1
|
38.74 Inches
Standard Deviation 5.76
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 2
|
38.35 Inches
Standard Deviation 5.61
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 3
|
38.44 Inches
Standard Deviation 5.97
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 4
|
37.89 Inches
Standard Deviation 5.87
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 6
|
38.14 Inches
Standard Deviation 5.46
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 8
|
37.38 Inches
Standard Deviation 6.17
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 10
|
37.36 Inches
Standard Deviation 6.10
|
|
Changes in Waist Circumference. [Baseline to Week 12]
Week 12
|
37.05 Inches
Standard Deviation 5.82
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Participants will independently measure their hip circumference in inches.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Hip Circumference. [Baseline to Week 12]
Baseline
|
44.24 Inches
Standard Deviation 6.34
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 1
|
43.84 Inches
Standard Deviation 5.85
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 2
|
43.32 Inches
Standard Deviation 5.64
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 3
|
43.56 Inches
Standard Deviation 5.79
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 4
|
43.21 Inches
Standard Deviation 5.71
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 6
|
43.06 Inches
Standard Deviation 6.02
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 8
|
42.80 Inches
Standard Deviation 5.98
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 10
|
42.45 Inches
Standard Deviation 6.61
|
|
Changes in Hip Circumference. [Baseline to Week 12]
Week 12
|
42.21 Inches
Standard Deviation 6.15
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Participants will independently measure their thigh circumference in inches.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Baseline
|
25.12 Inches
Standard Deviation 4.63
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 1
|
24.84 Inches
Standard Deviation 4.36
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 2
|
24.79 Inches
Standard Deviation 4.03
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 3
|
24.36 Inches
Standard Deviation 3.31
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 4
|
24.68 Inches
Standard Deviation 4.12
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 6
|
24.37 Inches
Standard Deviation 4.19
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 8
|
24.13 Inches
Standard Deviation 3.91
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 10
|
23.80 Inches
Standard Deviation 4.12
|
|
Changes in Thigh Circumference. [Baseline to Week 12]
Week 12
|
24.03 Inches
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Overall Health. [Baseline to Week 12]
Baseline
|
3.75 score on a scale
Standard Deviation 0.77
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 1
|
3.86 score on a scale
Standard Deviation 0.66
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 2
|
3.85 score on a scale
Standard Deviation 0.68
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 3
|
3.90 score on a scale
Standard Deviation 0.72
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 4
|
3.89 score on a scale
Standard Deviation 0.68
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 6
|
3.89 score on a scale
Standard Deviation 0.65
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 8
|
3.74 score on a scale
Standard Deviation 0.81
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 10
|
3.95 score on a scale
Standard Deviation 0.67
|
|
Changes in Overall Health. [Baseline to Week 12]
Week 12
|
3.91 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Energy Levels. [Baseline to Week 12]
Baseline
|
2.47 score on a scale
Standard Deviation 0.68
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 1
|
3.01 score on a scale
Standard Deviation 0.64
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 2
|
3.05 score on a scale
Standard Deviation 0.65
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 3
|
3.11 score on a scale
Standard Deviation 0.71
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 4
|
3.15 score on a scale
Standard Deviation 0.68
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 6
|
3.16 score on a scale
Standard Deviation 0.81
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 8
|
3.13 score on a scale
Standard Deviation 0.91
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 10
|
3.18 score on a scale
Standard Deviation 0.77
|
|
Changes in Energy Levels. [Baseline to Week 12]
Week 12
|
3.22 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Tiredness. [Baseline to Week 12]
Baseline
|
1.80 score on a scale
Standard Deviation 0.72
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 1
|
2.52 score on a scale
Standard Deviation 0.98
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 2
|
2.52 score on a scale
Standard Deviation 0.99
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 3
|
2.75 score on a scale
Standard Deviation 1.05
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 4
|
2.67 score on a scale
Standard Deviation 1.12
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 6
|
2.71 score on a scale
Standard Deviation 1.08
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 8
|
2.69 score on a scale
Standard Deviation 1.11
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 10
|
2.70 score on a scale
Standard Deviation 1.18
|
|
Changes in Tiredness. [Baseline to Week 12]
Week 12
|
2.90 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Overall Mood. [Baseline to Week 12]
Baseline
|
3.30 score on a scale
Standard Deviation 0.68
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 1
|
3.75 score on a scale
Standard Deviation 0.62
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 2
|
3.74 score on a scale
Standard Deviation 0.67
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 3
|
3.69 score on a scale
Standard Deviation 0.65
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 4
|
3.75 score on a scale
Standard Deviation 0.68
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 6
|
3.71 score on a scale
Standard Deviation 0.74
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 8
|
3.69 score on a scale
Standard Deviation 0.81
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 10
|
3.77 score on a scale
Standard Deviation 0.77
|
|
Changes in Overall Mood. [Baseline to Week 12]
Week 12
|
3.80 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Baseline
|
3.47 score on a scale
Standard Deviation 0.71
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 1
|
3.81 score on a scale
Standard Deviation 0.62
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 2
|
3.81 score on a scale
Standard Deviation 0.60
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 3
|
3.78 score on a scale
Standard Deviation 0.71
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 4
|
3.78 score on a scale
Standard Deviation 0.71
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 6
|
3.80 score on a scale
Standard Deviation 0.80
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 8
|
3.67 score on a scale
Standard Deviation 0.79
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 10
|
3.82 score on a scale
Standard Deviation 0.73
|
|
Changes in Mental Wellbeing. [Baseline to Week 12]
Week 12
|
3.84 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Ability to Focus. [Baseline to Week 12]
Baseline
|
3.11 score on a scale
Standard Deviation 0.93
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 1
|
3.55 score on a scale
Standard Deviation 0.79
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 2
|
3.65 score on a scale
Standard Deviation 0.79
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 3
|
3.68 score on a scale
Standard Deviation 0.72
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 4
|
3.66 score on a scale
Standard Deviation 0.86
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 6
|
3.63 score on a scale
Standard Deviation 0.92
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 8
|
3.59 score on a scale
Standard Deviation 0.85
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 10
|
3.69 score on a scale
Standard Deviation 0.82
|
|
Changes in Ability to Focus. [Baseline to Week 12]
Week 12
|
3.77 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.10
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Baseline
|
3.01 score on a scale
Standard Deviation 1.02
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 1
|
3.64 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 2
|
3.94 score on a scale
Standard Deviation 1.03
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 3
|
3.95 score on a scale
Standard Deviation 1.16
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 4
|
4.01 score on a scale
Standard Deviation 1.10
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 6
|
3.98 score on a scale
Standard Deviation 1.19
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 8
|
3.91 score on a scale
Standard Deviation 1.18
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 10
|
3.99 score on a scale
Standard Deviation 1.14
|
|
Changes in Frequency of Constipation. [Baseline to Week 12]
Week 12
|
4.10 score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Baseline
|
3.34 score on a scale
Standard Deviation 0.90
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 1
|
3.70 score on a scale
Standard Deviation 0.82
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 2
|
3.89 score on a scale
Standard Deviation 0.87
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 3
|
3.96 score on a scale
Standard Deviation 0.92
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 4
|
3.97 score on a scale
Standard Deviation 0.94
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 6
|
4.06 score on a scale
Standard Deviation 0.91
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 8
|
3.81 score on a scale
Standard Deviation 0.98
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 10
|
3.88 score on a scale
Standard Deviation 0.93
|
|
Changes in Severity of Constipation. [Baseline to Week 12]
Week 12
|
4.34 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Baseline
|
3.94 score on a scale
Standard Deviation 0.84
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 1
|
4.34 score on a scale
Standard Deviation 0.71
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 2
|
4.28 score on a scale
Standard Deviation 0.75
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 3
|
4.39 score on a scale
Standard Deviation 0.67
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 4
|
4.34 score on a scale
Standard Deviation 0.88
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 6
|
4.46 score on a scale
Standard Deviation 0.71
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 8
|
4.41 score on a scale
Standard Deviation 0.67
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 10
|
4.15 score on a scale
Standard Deviation 1.03
|
|
Changes in Bowel Movement Regularity. [Baseline to Week 12]
Week 12
|
4.31 score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Baseline
|
1.71 score on a scale
Standard Deviation 0.68
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 1
|
2.32 score on a scale
Standard Deviation 1.10
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 2
|
2.63 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 3
|
2.73 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 4
|
2.93 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 6
|
2.93 score on a scale
Standard Deviation 1.27
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 8
|
3.00 score on a scale
Standard Deviation 1.24
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 10
|
3.11 score on a scale
Standard Deviation 1.26
|
|
Changes in Frequency of Gas. [Baseline to Week 12]
Week 12
|
3.16 score on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Severity of Gas. [Baseline to Week 12]
Baseline
|
2.76 score on a scale
Standard Deviation 0.69
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 1
|
3.35 score on a scale
Standard Deviation 0.88
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 2
|
3.58 score on a scale
Standard Deviation 0.89
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 3
|
3.64 score on a scale
Standard Deviation 0.95
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 4
|
3.82 score on a scale
Standard Deviation 0.86
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 6
|
3.84 score on a scale
Standard Deviation 0.90
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 8
|
3.74 score on a scale
Standard Deviation 0.97
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 10
|
3.82 score on a scale
Standard Deviation 0.92
|
|
Changes in Severity of Gas. [Baseline to Week 12]
Week 12
|
3.92 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Baseline
|
2.13 score on a scale
Standard Deviation 0.94
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 1
|
2.71 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 2
|
3.16 score on a scale
Standard Deviation 1.23
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 3
|
3.22 score on a scale
Standard Deviation 1.22
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 4
|
3.41 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 6
|
3.52 score on a scale
Standard Deviation 1.21
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 8
|
3.50 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
week 10
|
3.66 score on a scale
Standard Deviation 1.26
|
|
Changes in Frequency of Bloating. [Baseline to Week 12]
Week 12
|
3.66 score on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Baseline
|
2.75 score on a scale
Standard Deviation 0.88
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 1
|
3.47 score on a scale
Standard Deviation 0.95
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 2
|
3.74 score on a scale
Standard Deviation 0.92
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 3
|
3.73 score on a scale
Standard Deviation 0.99
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 4
|
3.79 score on a scale
Standard Deviation 1.03
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 6
|
3.97 score on a scale
Standard Deviation 0.93
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 8
|
3.84 score on a scale
Standard Deviation 0.96
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 10
|
3.92 score on a scale
Standard Deviation 1.02
|
|
Changes in Severity of Bloating. [Baseline to Week 12]
Week 12
|
4.03 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, and Week 10Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Baseline
|
3.86 score on a scale
Standard Deviation 1.11
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 1
|
5.27 score on a scale
Standard Deviation 1.14
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 2
|
5.52 score on a scale
Standard Deviation 1.14
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 3
|
5.64 score on a scale
Standard Deviation 1.26
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 4
|
5.58 score on a scale
Standard Deviation 1.30
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 6
|
5.71 score on a scale
Standard Deviation 1.26
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 8
|
5.82 score on a scale
Standard Deviation 1.11
|
|
Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12]
Week 10
|
5.72 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12]
Baseline
|
2.54 score on a scale
Standard Deviation 1.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12]
Week 8
|
3.81 score on a scale
Standard Deviation 1.20
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Participants were asked to report the number of bowel movements they had in the previous week.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Changes in Number of Bowel Movements Per Week. [Baseline to Week 12]
Week 12
|
7.21 Number of bowel movements per week
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Baseline
|
1.94 score on a scale
Standard Deviation 0.97
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 1
|
2.77 score on a scale
Standard Deviation 1.23
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 2
|
2.95 score on a scale
Standard Deviation 1.17
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 3
|
3.16 score on a scale
Standard Deviation 1.13
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 4
|
3.27 score on a scale
Standard Deviation 1.15
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 6
|
3.23 score on a scale
Standard Deviation 1.24
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 8
|
3.28 score on a scale
Standard Deviation 1.23
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 10
|
3.42 score on a scale
Standard Deviation 1.25
|
|
Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12]
Week 12
|
3.47 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12Survey-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.
Outcome measures
| Measure |
Colon Broom Premium Supplement
n=98 Participants
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
|
|---|---|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Baseline
|
2.47 score on a scale
Standard Deviation 1.14
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 1
|
3.35 score on a scale
Standard Deviation 1.19
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 2
|
3.60 score on a scale
Standard Deviation 1.13
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 3
|
3.53 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 4
|
3.71 score on a scale
Standard Deviation 1.15
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 6
|
3.64 score on a scale
Standard Deviation 1.24
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 8
|
3.70 score on a scale
Standard Deviation 1.22
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 10
|
3.74 score on a scale
Standard Deviation 1.20
|
|
Changes in Frequency of Overeating. [Baseline to Week 12]
Week 12
|
3.75 score on a scale
Standard Deviation 1.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksAt 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.
Outcome measures
Outcome data not reported
Adverse Events
Colon Broom Premium Supplement
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colon Broom Premium Supplement
n=120 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
4/120 • Adverse event data were collected over the 12-week study period.
|
|
Gastrointestinal disorders
Bloating and Gas
|
1.7%
2/120 • Adverse event data were collected over the 12-week study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place