Effects of Gallotannins on the Gut Microbiome and How it Affects Inflammatory Markers Among Obese Individuals.

Part of paid clinical trials in Prairie View, Texas.

Sponsor
Prairie View A&M University
Study ID
NCT07505212
Status
Active Not Recruiting

Conditions

  • Obesity (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Gallotannin-rich mango — DIETARY_SUPPLEMENT
    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.
  • Lactiplantibacillus pentosus (probiotic) — DIETARY_SUPPLEMENT
    Lactiplantibacillus pentosus is a probiotic bacterium that can benefit gut health and may have additional benefits like reducing inflammation
  • No Treatment Added — OTHER
    This intervention has no treatment added so as to serve as a control for the other interventions.

Study Details

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)

Key Dates

Start date
Apr 14, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GT extract + Lactiplantibacillus pentosus arm
    In this group, stool sample provided by volunteers will be treated with GT extract and L. pentosus.
  • Active Comparator: Gallotannin extract from mango only
    In this group, stool sample provided by volunteers will be treated with GT extract only.
  • Active Comparator: Lactiplantibacillus pentosus supplement arm
    In this group, stool sample provided by volunteers will be treated with L. pentosus only.
  • Placebo Comparator: Control group

Primary Outcome Measure

Levels of GT metabolites and short-chain fatty acids (SFCAs) and changes in gut microbiome using HPLC-ESI-MSⁿ and 16s rDNA sequencing, respectively. [ Time Frame: Baseline (for all outcome measures) End of treatment at 12 hours (in vitro assessment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Collaborative Agricultural Research CenterPrairie ViewTexas77446-

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By research site
Collaborative Agricultural Research Center· Prairie View, TX

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