Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07505212

Active, not recruitingNot applicableInterventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexAll

Healthy volunteersAccepted

ConditionObesity (Disorder)

Full registry criteria

Inclusion Criteria: * Participants will be screened by a study before being included in the study using the following inclusion criteria. Participants must be lean or obese male or female aged 18-55 years, within the BMI ranges 18- 24.9 kg/m2 (lean) and 30-40 kg/m2 (obese) will be included. Participants will be measured for anthropometric parameters such as height and weight to confirm their BMI before being registered for the study. 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.

Treatments and study arms

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.

Primary outcomes

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

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 data…

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Collaborative Agricultural Research Center🇺🇸 Prairie View, Texas, United States

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