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Active Not Recruiting NCT07505212

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

Conditions: Obesity (Disorder)

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: Prairie View A&M University

Location: Collaborative Agricultural Research Center Prairie View Texas

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)

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07505212). StuddyBuddy aggregates publicly available trial information.