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Effect of Mango on Gut Microbiota and Metabolic Health

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ClinicalTrials.gov Identifier: NCT03825276
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Charles Couillard, Laval University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2021

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.




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 ]


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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
  • Body mass index (BMI) ≥25 kg/m2 and ≤40 kg/m2
  • Waist circumference ≥80 cm for women and ≥94 cm for men
  • 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 in the last 3 months
  • 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

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


Contacts
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Contact: Charles Couillard, PhD 418-656-2131 ext 12855 Charles.Couillard@fsaa.ulaval.ca

Locations
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Canada
Laval University Recruiting
Québec, Canada, G1V 0A6
Contact: Charles Couillard, PhD    418-656-2131 ext 12855    Charles.Couillard@fsaa.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Charles.Couillard@fsaa.ulaval.ca Couillard, PhD Laval University

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Responsible Party: Charles Couillard, Professor, Laval University
ClinicalTrials.gov Identifier: NCT03825276     History of Changes
Other Study ID Numbers: MANGO 2018-147
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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