Effect of Mango on Gut Microbiota and Metabolic Health

July 5, 2021 updated by: Charles Couillard, Laval University

Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study

Mango is rich in bioactive compounds such as dietary polyphenols and carotenoids, which may explain its beneficial effect on health. Polyphenols accumulate in the gut where they can positively modulate the microbiota. As gut microbiota may have a strong influence on cardiometabolic health, we hypothesize that mango consumption improves metabolic profile in overweight or obese individuals through beneficial changes in gut microbiota. The study of metagenomics, transcriptomics and metabolomics will be used to validate this hypothesis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 0A6
        • Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and premenopausal women
  • At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥ 80 cm for women and ≥ 94 cm for men
  • At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L
  • Caucasian origin

Exclusion Criteria:

  • Nicotine use
  • Metabolic disorders or use of medication that may affect parameters measured in the study
  • Use of dietary supplements or natural health product that may affect parameters measured in the study
  • Use of antibiotics in the last 3 months
  • Surgery in the last 3 months or planned during the study timeline
  • Alcohol consumption >2 drinks/day
  • Weight change >5% in the last 3 months
  • Mango aversion, allergy or intolerance
  • Dietary restrictions (vegetarian, gluten avoidance...)
  • Berries consumption >1 serving/day
  • Pregnancy, breastfeeding or pregnancy planned within 3-6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mango consumption
Dietary supplement: Mango consumption
Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in waist circumference of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in hip circumference of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
Waist and hip circumference will be combined to report waist to hip ratio
8 weeks
Height of overweight/obese men and women taking frozen mangos daily
Time Frame: Baseline
Baseline
Changes in weight of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
Weight and height will be combined to report BMI
8 weeks
Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
Gene-level expression from >20,000 annotated genes will be examined
8 weeks
Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
Metabolites include acylcarnitines, glycerophospholipids, sphingolipids, sugars, amino acids, biogenic amines
8 weeks
Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
Stool samples will be collected and whole metagenome shotgun sequencing analysis will be conducted
8 weeks
Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks
Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Charles.Couillard@fsaa.ulaval.ca Couillard, PhD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANGO 2018-147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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