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

NCT07505212 | Active Not Recruiting

• 2 other identifiers: 2024-0112023-68015-40572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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
• Mango juice only
• Mango + L. pentosus
• L. pentosus only
• Control (lean individuals)
• Visit sample collection site one time during the study (week 1)

Conditions

Obesity (Disorder)

Keywords

Gut microbiome; Obesity-related inflammation; Gallotannin; Lactiplantibacillus pentosus

Outcome Measures

Primary Outcomes (1)

• Levels of GT metabolites and short-chain fatty acids (SFCAs) and changes in gut microbiome using HPLC-ESI-MSⁿ and 16s rDNA sequencing, respectively.

  GT metabolites and short-chain fatty acids (SCFAs) will be quantified using HPLC-ESI-MSⁿ, an advanced analytical technique that integrates compound separation, ionization, and structural characterization. In this method, HPLC separates mixture components based on their chemical properties, after which electrospray ionization (ESI) converts analytes into charged ions while preserving their structure. These ions are then subjected to multi-stage mass spectrometry (MSⁿ), enabling successive fragmentation and detailed structural identification of metabolites. Changes in gut microbiome composition will be assessed using 16S rDNA sequencing, a molecular technique that identifies and characterizes bacteria based on the highly conserved 16S ribosomal RNA gene. This involves DNA extraction, PCR amplification of the 16S rRNA gene, sequencing of variable regions, and comparison with reference databases to determine microbial diversity and composition.

  Baseline (for all outcome measures) End of treatment at 12 hours (in vitro assessment)

Study Arms (4)

GT extract + Lactiplantibacillus pentosus arm

ACTIVE COMPARATOR

In this group, stool sample provided by volunteers will be treated with GT extract and L. pentosus.

Dietary Supplement: Gallotannin-rich mango; Dietary Supplement: Lactiplantibacillus pentosus (probiotic)

Gallotannin extract from mango only

ACTIVE COMPARATOR

In this group, stool sample provided by volunteers will be treated with GT extract only.

Dietary Supplement: Gallotannin-rich mango

Lactiplantibacillus pentosus supplement arm

ACTIVE COMPARATOR

In this group, stool sample provided by volunteers will be treated with L. pentosus only.

Dietary Supplement: Lactiplantibacillus pentosus (probiotic)

Control group

PLACEBO COMPARATOR

Other: No Treatment Added

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.

Also known as: Ataulfo mango

GT extract + Lactiplantibacillus pentosus arm; Gallotannin extract from mango only

Lactiplantibacillus pentosus (probiotic) DIETARY_SUPPLEMENT

Lactiplantibacillus pentosus is a probiotic bacterium that can benefit gut health and may have additional benefits like reducing inflammation

GT extract + Lactiplantibacillus pentosus arm; Lactiplantibacillus pentosus supplement arm

No Treatment Added OTHER

This intervention has no treatment added so as to serve as a control for the other interventions.

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prairie View A&M University: lead

Study Sites (1)

Collaborative Agricultural Research Center

Prairie View, Texas, 77446, United States

Location

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MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Janet Antwi, Doctor of Philosophy

  Prairie View A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: April 1, 2026
• Study Start: April 14, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After publication. No end date.
• Access Criteria: Investigators who have been approved by IRB. All the de-identified data. Investigators will need to request it from the PI.

Locations

US (1)