Assessment of the Effect of Different Varieties of Grapes on Postprandial Glycemia and Insulinemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Glycaemic response
研究概览
简要总结
The goal of this intervention study is to examine the glucose increase in blood, during 2 hours after consuming different varieties of grapes, in men and women with normal or excess body weight. The main question it aims to answer is:
can a variety of red grape reduce the glucose curve compared to a reference variety?
Participants will have to attend the Center for nutrition research facilities in three occasions, fasted for at least 8 hours. Once there, they will be measured and monitored. A canula will be inserted and once they finish eating 300g of grapes, blood extractions will be performed at minutes 15, 30, 60, 90 and 120.
详细描述
The main purpose of this study is to evaluate how the glucose and insulin curves develop after consuming different grapes varieties. Still, we also want to evaluate how the serum metabolome changes with the three varieties after 120 minutes. Therefore, a metabolomic study will be done in samples of volunteers at this time point.
The intervention is longitudinal and in three arms (one per variety). Due to the harvest of the different varieties, it cannot be crossover, but each subject will consume the three varieties.
At each visit, the subjects will undergo the same schedule:
- Arrival in a fasting state of at least 8 hours.
- Insertion of cannula and extraction of fasting samples
- Consumption of approximately 300 g of grapes (50 g of Carbohydrates).
- Extraction of blood samples at 15, 30, 60, 90 and 120 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baseline glycaemia between 70 and 100 mg/dL
- •BMI between 18.5 kg/m2 and 29.9 kg/m
- •Absence of disease or alterations related to gastrointestinal status.
- •Signed written informed consent.
排除标准
- •Glycaemic levels out of the reference inclusion criteria (below 70 or over 100 mg/dL)
- •Subjects presenting BMI out of the limits set.
- •Subjects with unstable body weight the three months prior the start of the study (+/- 3 Kg)
- •Subjects not able to attend the preestablished visits
- •Women pregnant or lactating
- •Subjects undergoing pharmacological treatment
结局指标
主要结局
Glycaemic response
时间窗: 120 minutes
Assessment of serum glucose evolution after consuming 50 g of carbohydrates in grapes
Insulinemic response
时间窗: 120 minutes
Assessment of serum insulin evolution after consuming 50 g of carbohydrates in grapes
Insulin Resistance Index (HOMA-IR) response
时间窗: 120 minutes
Assessment of insulin resistance evolution after consuming 50 g of carbohydrates in grapes
Metabolome composition
时间窗: 120 minutes
Metabolomic analysis after grapes consumption
次要结局
- AST(0 minutes)
- Total cholesterol(0 minutes)
- LDL - cholesterol(0 minutes)
- HDL-cholesterol(0 minutes)
- Triglycerides(0 minutes)
- ALT(0 minutes)
研究者
Santiago Navas
Researcher at the Center for Nutrition Research, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra