Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mango consumption
干预措施: Mango consumption (Dietary Supplement)
结局指标
主要结局
Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
时间窗: 8 weeks
次要结局
- Changes in weight of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in glycated hemoglobin (HbA1c) in 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)
- Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in waist circumference 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 body mass index (BMI) of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in plasma interleukin-6 (IL-6) concentration 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 plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily(8 weeks)
- Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily(8 weeks)
研究者
Charles Couillard
Professor
Laval University