Effect of Mango on Gut Microbiota and Metabolic Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Gut Microbiota, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Mango consumption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily |  | 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 |  | 8 weeks | 
| Changes in hip circumference of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| 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 | 8 weeks | 
| Height of overweight/obese men and women taking frozen mangos daily |  | Baseline | 
| Changes in weight of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| 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 | 8 weeks | 
| Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| 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 | 8 weeks | 
| 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 | 8 weeks | 
| 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 | 8 weeks | 
| Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 
| Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mango, Polyphenols, Inflammation, Insulin resistance, Transcriptomic, Metabolomic, Metagenomic