Effects of Gallotannins on the Gut Microbiome and How it Affects Inflammatory Markers Among Obese Individuals. (NCT07505212)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to understand how gallotannin-rich (GT-rich) mangoes can reduce the inflammatory markers in obese individuals in vitro. The study will also seek to explore how gallotannins are metabolized in the gut microbiome. The main questions the research aims to answer are: * What is the impact of GT extract from mango and Lactiplantibacillus pentosus supplementation on inflammatory biomarkers in obese individuals? * Does the combination of GTs and L. pentosus exhibit synergistic effects in modulating specific microbial taxa associated with obesity and inflammation compared to either intervention alone? * Does genetic variation among individuals with obesity account for the ability to metabolize gallotannins? Researchers will compare the effects of GT extract from mango juice, a combination of GT-rich extract, and L. pentosus probiotic supplement on samples (stool) provided by obese individuals, to samples provided by a lean control group to see if gallotannins and gallotannins + probiotic supplementation reduce inflammation in obesity. Participants will * Be grouped into 4 treatment groups 1. Mango juice only 2. Mango + L. pentosus 3. L. pentosus only 4. Control (lean individuals) * Visit sample collection site one time during the study (week 1)
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (3 items).
Location: Collaborative Agricultural Research Center — Prairie View, Texas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with history of acute cardiac events, stroke, or cancer, recurrent hospitalizations, drug treatment of listed conditions within 6 months before study begin, abuse of alcohol/substance, on medications against T2DM or related diseases, smoking \> 1 pack/week, seizures (all within the last 6 months) will be excluded from the study.
- Participants with history of liver, intestinal or renal dysfunction, pregnancy or lactation, allergy against GTs, mangos, history of hepatitis B, C, or HIV, use of systemic antibiotics within 1 months of screening, participation in other interventional research study, intake of herbal dietary supplements.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Collaborative Agricultural Research Center — Prairie View, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.