PA-GH-01
Dietary Supplement1 capsule after breakfast once a day
NCT Number: NCT05952232
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Dr. Kumta Mali's Clinic, Mumbai, Maharashtra, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule after breakfast once a day
1 capsule after breakfast once a day
1 capsule after breakfast once a day
1 capsule after breakfast once a day
Time frame: Day 29
Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline
Time frame: Day 29
Gut protection as assessed by the Aspirin challenge test from baseline
Time frame: Day 29
Stool consistency as assessed by Bristol Stool Type from baseline
Time frame: Day 29
Gut microbiome as assessed by the fecal pH from baseline
Time frame: Day 29
Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline
Time frame: Day 29
The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline
Time frame: Day 29
Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline
Time frame: Day 29
Motivation to exercise as assessed by VAS score from baseline
Vedic Lifesciences Pvt. Ltd.
Industry
A Randomized, Double-blind, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut - a Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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