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Effect of Mango on Gut Microbiota and Metabolic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825276
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Charles Couillard, Laval University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gut Microbiota Metabolic Syndrome Dietary Supplement: Mango consumption Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  2. Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  3. Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  4. Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  5. Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  6. Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Changes in waist circumference of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  2. Changes in hip circumference of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  3. 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

  4. Height of overweight/obese men and women taking frozen mangos daily [ Time Frame: Baseline ]
  5. Changes in weight of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  6. 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

  7. Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  8. Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  9. Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  10. Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  11. Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  12. Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  13. Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  14. 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 ]
  15. 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

  16. 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

  17. 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

  18. Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]
  19. Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825276


Locations
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Canada
Laval University
Québec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Charles.Couillard@fsaa.ulaval.ca Couillard, PhD Laval University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Charles Couillard, Professor, Laval University
ClinicalTrials.gov Identifier: NCT03825276    
Other Study ID Numbers: MANGO 2018-147
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles Couillard, Laval University:
Mango
Polyphenols
Inflammation
Insulin resistance
 Transcriptomic
Metabolomic
Metagenomic
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases