Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects: Role of Polyphenols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Postprandial glucose (300-420 min)
研究概览
简要总结
The aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols). Besides, the contribution of polyphenols to the so-called second-meal effect has not been explored. It should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.
详细描述
Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).
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
- Double (Participant, Care Provider)
盲法说明
GRAP and PLA will have the same aspect, so neither the participant and the care provider will know the received treatment at each stage.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity (BMI = 30-40 kg/m2).
排除标准
- •Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- •Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
- •Values above the following ones: glucose, > 115 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- •Previous bariatric surgery.
- •Volunteers participating in other studies (currently or during last year) or weight loss plans.
- •Pregnant or breastfeeding women.
- •Adherence to vegetarian diets or usual consumption of dietary supplements.
结局指标
主要结局
Postprandial glucose (300-420 min)
时间窗: Up to two months
Changes of postprandial blood glucose as result of supplementation with grapes, measured area under the curve for the period 300-420 min
次要结局
未报告次要终点
研究者
Jara Pérez-Jiménez
Principal Investigator
National Research Council, Spain