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Effect of Mango on Gut Microbiota and Metabolic Health

Primary Purpose

Gut Microbiota, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mango consumption
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gut Microbiota focused on measuring Mango, Polyphenols, Inflammation, Insulin resistance, Transcriptomic, Metabolomic, Metagenomic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laval University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mango consumption

Arm Description

Outcomes

Primary Outcome Measures

Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2019
Last Updated
July 5, 2021
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03825276
Brief Title
Effect of Mango on Gut Microbiota and Metabolic Health
Official Title
Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, Metabolic Syndrome
Keywords
Mango, Polyphenols, Inflammation, Insulin resistance, Transcriptomic, Metabolomic, Metagenomic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mango consumption
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Mango consumption
Intervention Description
Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.
Primary Outcome Measure Information:
Title
Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in waist circumference of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in hip circumference of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily
Description
Waist and hip circumference will be combined to report waist to hip ratio
Time Frame
8 weeks
Title
Height of overweight/obese men and women taking frozen mangos daily
Time Frame
Baseline
Title
Changes in weight of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily
Description
Weight and height will be combined to report BMI
Time Frame
8 weeks
Title
Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
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
Title
Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily
Description
Gene-level expression from >20,000 annotated genes will be examined
Time Frame
8 weeks
Title
Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily
Description
Metabolites include acylcarnitines, glycerophospholipids, sphingolipids, sugars, amino acids, biogenic amines
Time Frame
8 weeks
Title
Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily
Description
Stool samples will be collected and whole metagenome shotgun sequencing analysis will be conducted
Time Frame
8 weeks
Title
Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks
Title
Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles.Couillard@fsaa.ulaval.ca Couillard, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36034894
Citation
Keathley J, de Toro-Martin J, Kearney M, Garneau V, Pilon G, Couture P, Marette A, Vohl MC, Couillard C. Gene expression signatures and cardiometabolic outcomes following 8-week mango consumption in individuals with overweight/obesity. Front Nutr. 2022 Aug 11;9:918844. doi: 10.3389/fnut.2022.918844. eCollection 2022.
Results Reference
derived
PubMed Identifier
35506190
Citation
Keathley J, Kearney M, Garneau V, Toro-Martin J, Varin TV, Pilon G, Couture P, Marette A, Vohl MC, Couillard C. Changes in systolic blood pressure, postprandial glucose, and gut microbial composition following mango consumption in individuals with overweight and obesity. Appl Physiol Nutr Metab. 2022 May;47(5):565-574. doi: 10.1139/apnm-2021-0637. Epub 2022 May 4.
Results Reference
derived

Learn more about this trial

Effect of Mango on Gut Microbiota and Metabolic Health

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