N/A
N=120
A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management
Gut Health · Metabolism · Weight Loss · Energy
Bottom Line
View on ClinicalTrials.gov: NCT06023082 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Changes in Body Weight. [Baseline to Week 12] — 194.81; 194.35; 194.17; 193.68 Pounds (lbs) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colon Broom Premium supplement (Dietary_supplement)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Gut Health, UAB
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Body Weight. [Baseline to Week 12] |
194.81; 194.35; 194.17; 193.68; 192.84; 192.81 | <0.0001 sig |
| PRIMARY Changes in Waist Circumference. [Baseline to Week 12] |
38.43; 38.74; 38.35; 38.44; 37.89; 38.14 | <0.0001 sig |
| PRIMARY Changes in Hip Circumference. [Baseline to Week 12] |
44.24; 43.84; 43.32; 43.56; 43.21; 43.06 | <0.0001 sig |
| PRIMARY Changes in Thigh Circumference. [Baseline to Week 12] |
25.12; 24.84; 24.79; 24.36; 24.68; 24.37 | <0.0001 sig |
| SECONDARY Changes in Overall Health. [Baseline to Week 12] |
3.75; 3.86; 3.85; 3.90; 3.89; 3.89 | 0.4907 |
| SECONDARY Changes in Energy Levels. [Baseline to Week 12] |
2.47; 3.01; 3.05; 3.11; 3.15; 3.16 | <0.0001 sig |
| SECONDARY Changes in Tiredness. [Baseline to Week 12] |
1.80; 2.52; 2.52; 2.75; 2.67; 2.71 | <0.0001 sig |
| SECONDARY Changes in Overall Mood. [Baseline to Week 12] |
3.30; 3.75; 3.74; 3.69; 3.75; 3.71 | <0.0001 sig |
| SECONDARY Changes in Mental Wellbeing. [Baseline to Week 12] |
3.47; 3.81; 3.81; 3.78; 3.78; 3.80 | 0.0016 sig |
| SECONDARY Changes in Ability to Focus. [Baseline to Week 12] |
3.11; 3.55; 3.65; 3.68; 3.66; 3.63 | <0.0001 sig |
| SECONDARY Changes in Amount of Daily Leisure Time Spent Doing Something Active. [Baseline to Week 12] |
2.61; 3.04; 3.08; 3.23; 3.11; 3.13 | <0.0001 sig |
| SECONDARY Changes in Frequency of Constipation. [Baseline to Week 12] |
3.01; 3.64; 3.94; 3.95; 4.01; 3.98 | <0.0001 sig |
| SECONDARY Changes in Severity of Constipation. [Baseline to Week 12] |
3.34; 3.70; 3.89; 3.96; 3.97; 4.06 | 0.0002 sig |
| SECONDARY Changes in Bowel Movement Regularity. [Baseline to Week 12] |
3.94; 4.34; 4.28; 4.39; 4.34; 4.46 | 0.001 sig |
| SECONDARY Changes in Frequency of Gas. [Baseline to Week 12] |
1.71; 2.32; 2.63; 2.73; 2.93; 2.93 | <0.0001 sig |
| SECONDARY Changes in Severity of Gas. [Baseline to Week 12] |
2.76; 3.35; 3.58; 3.64; 3.82; 3.84 | <0.0001 sig |
| SECONDARY Changes in Frequency of Bloating. [Baseline to Week 12] |
2.13; 2.71; 3.16; 3.22; 3.41; 3.52 | <0.0001 sig |
| SECONDARY Changes in Severity of Bloating. [Baseline to Week 12] |
2.75; 3.47; 3.74; 3.73; 3.79; 3.97 | <0.0001 sig |
| SECONDARY Changes in Discomfort Associated With Gut Issues. [Baseline to Week 12] |
3.86; 5.27; 5.52; 5.64; 5.58; 5.71 | <0.0001 sig |
| SECONDARY Changes in Frequency of Feeling Hunger After Eating a Meal. [Baseline to Week 12] |
2.54; 3.38; 3.69; 3.71; 3.71; 3.78 | <0.0001 sig |
| SECONDARY Changes in Number of Bowel Movements Per Week. [Baseline to Week 12] |
5.63; 7.13; 7.19; 7.26; 7.75; 7.59 | <0.0001 sig |
| SECONDARY Changes in the Frequency of Experiencing Food Cravings. [Baseline to Week 12] |
1.94; 2.77; 2.95; 3.16; 3.27; 3.23 | <0.0001 sig |
| SECONDARY Changes in Frequency of Overeating. [Baseline to Week 12] |
2.47; 3.35; 3.60; 3.53; 3.71; 3.64 | <0.0001 sig |
Summary
This study will evaluate the efficacy of Colon Broom Premium on gut health, metabolism, weight management, and energy levels. The study will be conducted as a virtual single-group trial in which all 120 participants will use the test product. This study will last 12 weeks, and participants will take the product daily. Participants will complete study-specific questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12. Participants will also provide body weight measurements and body circumference measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12.
Before & after photographs will be provided at Baseline and Week 12.
The Colon Broom Premium supplement contains psyllium seed husk powder, L-carnitine tartrate, CapsimaxⓇ cayenne fruit extract, chromium (as chromium picolinate), vitamin B6 (as pyridoxine HCl), vitamin B12 (as cyanocobalamin), and Iron.
The study Sponsor and product name will remain anonymous to participants throughout the trial. The Sponsor name or product name will not be included in any participant-facing documentation.
Eligibility Criteria
Inclusion Criteria
- Male or female between ages 30-50
- Have a BMI of 25 or more
- Have self-reported issues with gas, bloating, constipation, heartburn/acid reflux, abdominal pain, or digestion at least three times per week
- Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study
- Be generally healthy - do not live with any uncontrolled chronic disease
Exclusion Criteria
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone who is currently undergoing, or planning to to undergo any gut or weight-related procedures in the next 12 week.
- Anyone with a history of severe allergic reactions including but not limited to psyllium seed husk powder and strawberries
- Anyone taking any prescription medications targeting the gut
- Anyone taking any supplements targeting the gut in the past month
- Use of antibiotics in the past 3 months
- Women who are pregnant, breastfeeding, or attempting to become pregnant
- Anyone unwilling to follow the study protocol
- Anyone following any particular dietary regime, such as a ketogenic diet or intermittent fasting.
- Anyone who has had bariatric surgery in the past 6 months
- Anyone who has chronic constipation
- Anyone who has Irritable Bowel Disease (IBD)
- Anyone diagnosed with severe digestive issues
Data sourced from ClinicalTrials.gov (NCT06023082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.