Effect of Mango on Gut Microbiota and Metabolic Health

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Спонзори

Laval University

КЛИНИЧКО ИСПИТИВАЊЕ: NCT03825276

BioSeek: nct03825276

Кључне речи

Апстрактан

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.

Датуми

Последња верификација:	02/29/2020
Фирст Субмиттед:	01/21/2019
Предвиђена пријава послата:	01/28/2019
Прво објављено:	01/30/2019
Послато последње ажурирање:	03/23/2020
Последње ажурирање објављено:	03/24/2020
Стварни датум почетка студије:	01/14/2019
Процењени датум примарног завршетка:	12/19/2019
Предвиђени датум завршетка студије:	11/30/2021

Стање или болест

Gut Microbiota

Metabolic Syndrome

Интервенција / лечење

Dietary Supplement: Mango consumption

Фаза

Групе руку

Арм	Интервенција / лечење
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.

Критеријуми

Узраст подобан за студирање	18 Years До 18 Years
Полови подобни за студирање	All
Прихвата здраве волонтере	да
Критеријуми	Inclusion Criteria: - Healthy men and premenopausal women - Body mass index (BMI) ≥25 kg/m2 and ≤40 kg/m2 - Waist circumference ≥80 cm for women and ≥94 cm for men - 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 in the last 3 months - 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

Исход

Примарне мере исхода

1. Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

2. Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

3. Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

4. Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

5. Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

6. Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

Секундарне мере исхода

1. Changes in waist circumference of overweight/obese men and women taking frozen mangos daily [8 weeks]

2. Changes in hip circumference of overweight/obese men and women taking frozen mangos daily [8 weeks]

3. 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

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

5. Changes in weight of overweight/obese men and women taking frozen mangos daily [8 weeks]

6. 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

7. Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily [8 weeks]

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

9. Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily [8 weeks]

10. Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily [8 weeks]

11. Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily [8 weeks]

12. Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

13. Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

14. Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

15. 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

16. 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

17. 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

18. Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

19. Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily [8 weeks]

Effect of Mango on Gut Microbiota and Metabolic Health

Кључне речи

polyphenol

гојазност

carotenoid

манго

mangifera indica