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The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA-GH-01 | Active Comparator | 1 capsule after breakfast once a day |
|
| MK-GH-04 | Active Comparator | 1 capsule after breakfast once a day |
|
| TSH-GH-03 | Active Comparator | 1 capsule after breakfast once a day |
|
| PA-GH-02 | Placebo Comparator | 1 capsule after breakfast once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA-GH-01 | Dietary Supplement | 1 capsule after breakfast once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Gut protection as assessed by the Aspirin challenge test from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Stool consistency as assessed by Bristol Stool Type from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Gut microbiome as assessed by the fecal pH from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline | Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kumta Mali's Clinic | Mumbai | Maharashtra | 400053 | India | ||
| Dr. Preeti Bawaskar's Clinic |
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Randomized, double-blind, Placebo-controlled
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| MK-GH-04 |
| Dietary Supplement |
1 capsule after breakfast once a day |
|
| TSH-GH-03 | Dietary Supplement | 1 capsule after breakfast once a day |
|
| PA-GH-02 | Dietary Supplement | 1 capsule after breakfast once a day |
|
| Day 29 |
| To assess efficacy of the natural ingredients on gut permeability as assessed by the change in | Motivation to exercise as assessed by VAS score from baseline | Day 29 |
| Thane |
| Maharashtra |
| 400607 |
| India |