Effect of Mango on Gut Microbiota and Metabolic Health

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03825276
• Other study ID #: MANGO 2018-147
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2022
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Laval University	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

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