Effect of Mango on Gut Microbiota and Metabolic Health

Sponsor

Laval University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03825276

Collaborator

(none)

Enrollment

Location

Arm

46.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiota Metabolic Syndrome	Dietary Supplement: Mango consumption	N/A

Study Design

Study Type:

Interventional

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 :

Jan 15, 2019

Actual Primary Completion Date :

Dec 20, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

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

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 [8 weeks]
Waist and hip circumference will be combined to report waist to hip ratio
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 [8 weeks]
Weight and height will be combined to report BMI
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 [8 weeks]
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 [8 weeks]
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 [8 weeks]
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 [8 weeks]
Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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