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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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