Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
研究概览
简要总结
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk.
The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 25 and 35 kg/m2 inclusive
- •Waist circumference > 80 cm for women and > 96 cm for men
- •Fibers intake ≤ 25g/day
排除标准
- •History of digestive surgery or diseases
- •Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- •Current probiotics, prebiotics, fibers complement, and/or any products modulating glucose and lipid metabolism
- •Volunteer with a dietary restriction (vegetarian or high-protein diet for example)
- •Current weight loss diet
- •Pregnant or lactating woman or woman who do not use effective contraception
- •Drinking more than 3 glasses of alcohol per day (>30g/day)
- •Smoking volunteer
结局指标
主要结局
Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
时间窗: Through study completion, an average of 18 days
Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
次要结局
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of digestive hormones (GLP-1 and ghrelin)(Through study completion, an average of 18 days)
- Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis(Through study completion, an average of 18 days)
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of glycaemia and insulinemia(Through study completion, an average of 18 days)
- Baseline characteristics(Day 0 (at fasting before the standardized breakfast intake))
- Satiety and digestive tolerance(Through study completion, 24 hours following the last day)
- Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)(Through study completion, an average of 18 days)
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)(Through study completion, 24 hours following the last day)
- Dietary intake(Through study completion, an average of 18 days)