Effects of Gallotannins on the Gut Microbiome and How it Affects Inflammatory Markers Among Obese Individuals.
NCT07505212 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-06-09
Summary
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)
Conditions
- Obesity (Disorder)
Interventions
- DIETARY_SUPPLEMENT
-
Gallotannin-rich mango
This mango is high in polyphenols, specifically hydrolysable tannins, which are easily broken down by microbes in the colon. The metabolites formed can improve the gut microbiome population and also improve immune response.
- DIETARY_SUPPLEMENT
-
Lactiplantibacillus pentosus (probiotic)
Lactiplantibacillus pentosus is a probiotic bacterium that can benefit gut health and may have additional benefits like reducing inflammation
- OTHER
-
No Treatment Added
This intervention has no treatment added so as to serve as a control for the other interventions.
Sponsors & Collaborators
-
Prairie View A&M University
lead OTHER
Principal Investigators
-
Janet Antwi, Doctor of Philosophy · Prairie View A&M University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-14
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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