Clinical trial NCT03825276: Effect of Mango on Gut Microbiota and Metabolic Health
Official title: Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gut Microbiota
Metabolic Syndrome
Keywords: Mango
Polyphenols
Inflammation
Insulin resistance
Transcriptomic
Metabolomic
Metagenomic
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in waist circumference of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in hip circumference of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Height of overweight/obese men and women taking frozen mangos daily
timeFrame: Baseline
measure: Changes in weight of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
measure: Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University
Study officials:
affiliation: Laval University
name: Charles.Couillard@fsaa.ulaval.ca Couillard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keathley J, de Toro-Martin J, Kearney M, Garneau V, Pilon G, Couture P, Marette A, Vohl MC, Couillard C. Gene expression signatures and cardiometabolic outcomes following 8-week mango consumption in individuals with overweight/obesity. Front Nutr. 2022 Aug 11;9:918844. doi: 10.3389/fnut.2022.918844. eCollection 2022.
citation: Keathley J, Kearney M, Garneau V, Toro-Martin J, Varin TV, Pilon G, Couture P, Marette A, Vohl MC, Couillard C. Changes in systolic blood pressure, postprandial glucose, and gut microbial composition following mango consumption in individuals with overweight and obesity. Appl Physiol Nutr Metab. 2022 May;47(5):565-574. doi: 10.1139/apnm-2021-0637. Epub 2022 May 4.