AzTrials
AzTrials

Gut MicrobiotaNCT03825276

Effect of Mango on Gut Microbiota and Metabolic Health

A study testing Mango consumption in people with Gut Microbiota and Metabolic Syndrome, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Gut Microbiota, Metabolic Syndrome
What is being tested?
Mango consumption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteCanada
Study dates
15 Jan 2019to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Laval University

    Québec, G1V 0A6

Other trials in Canada

About this study

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

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.

Being tested
Mango consumption
Keywords
Mango, Polyphenols, Inflammation, Insulin resistance, Transcriptomic, Metabolomic, Metagenomic
Medical subject headings
Metabolic Syndrome, Inflammation, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mango consumptionDietary supplement

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

Study groups in NCT03825276
Study groupRoleWhat they receive
Mango consumptionExperimentalNot described
Receives: Dietary Supplement: Mango consumption

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  2. Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  3. Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  4. Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  5. Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  6. Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

Secondary outcomes (19)

  1. Changes in waist circumference of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  2. Changes in hip circumference of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  3. 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

    Measured: 8 weeks

  4. Height of overweight/obese men and women taking frozen mangos daily

    Measured: Baseline

  5. Changes in weight of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  6. 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

    Measured: 8 weeks

  7. Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  8. Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  9. Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  10. Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  11. Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  12. Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  13. Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  14. Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  15. 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

    Measured: 8 weeks

  16. 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

    Measured: 8 weeks

  17. 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

    Measured: 8 weeks

  18. Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

  19. Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start15 Jan 2019
  3. Primary completion20 Dec 2019
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03825276
Sponsor's protocol ID
MANGO 2018-147
Status last verified
Jul 2021
First submitted
22 Jan 2019
Last updated
7 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36034894

  • 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.

    PubMed 35506190

Questions about this trial

What is this clinical trial studying?

A study testing Mango consumption in people with Gut Microbiota and Metabolic Syndrome, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03825276, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in