NCT03825276

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

January 22, 2019

Last Update Submit

July 5, 2021

Conditions

Gut MicrobiotaMetabolic Syndrome

Keywords

MangoPolyphenolsInflammationInsulin resistanceTranscriptomicMetabolomicMetagenomic

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (19)

  • 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

  • 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

  • +14 more secondary outcomes

Study Arms (1)

Mango consumption

EXPERIMENTAL
Dietary Supplement: Mango consumption

Interventions

Mango consumptionDIETARY_SUPPLEMENT

Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.

Mango consumption

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University

Québec, G1V 0A6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36034894DERIVED

  • 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.

    PMID: 35506190DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammationInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charles.Couillard@fsaa.ulaval.ca Couillard, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 31, 2019

Study Start

January 15, 2019

Primary Completion

December 20, 2019

Study Completion

December 1, 2022

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

CA(1)