Mango + Probiotic for Obesity

Overseen By Obed Akwaa Harrison, Doctor Philosophy

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Prairie View A&M University

Must not be taking: T2DM medications, Systemic antibiotics

Disqualifiers: Cardiac events, Stroke, Cancer, others

Compensation: Varies

Number of Visits: 1

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

Janet Antwi, Doctor of Philosophy

Principal Investigator

Prairie View A&M University

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants will be measured for anthropometric parameters such as height and weight to confirm their BMI before being registered for the study

BMI ranges: 18-24.9 kg/m2 (lean) and 30-40 kg/m2 (obese)

I am between 18 and 55 years old and am either lean or obese.

Exclusion Criteria

Participation in other interventional research study

I have had a heart attack, stroke, or cancer in the past.

Recurrent hospitalizations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are grouped into 4 treatment groups and receive interventions with GT extract, L. pentosus, or both

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in inflammatory biomarkers and gut microbiome composition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gallotannin-rich mango
• Lactiplantibacillus pentosus
• No Treatment Added

How Is the Trial Designed?

Group I: GT extract + Lactiplantibacillus pentosus arm Active Control 2 Interventions

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

Group II: Gallotannin extract from mango only Active Control 1 Intervention

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

Group III: Lactiplantibacillus pentosus supplement arm Active Control 1 Intervention

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

Group IV: Control group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Prairie View A&M University

Lead Sponsor

Trials

1

Recruited

30+