Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance, a Crossover Clinical Trial (BGI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Augmentation index
研究概览
简要总结
This is a crossover clinical trial aimed at adults (aged 20-40 years, with no cardiovascular disease), selected by consecutive sampling at urban primary care health clinics in Salamanca (Spain). Each subject will complete three interventions, with a washout period of one week: control breakfast (water), low glycemic index breakfast (apple, yogurt, walnuts and black chocolate) and high glycemic index breakfast (grape juice, bread and strawberry jam). The postprandial effect will be assessed at 60 and 120 minutes from each breakfast, measuring blood glucose and insulin and cognitive performance. Measurements will be performed of central blood pressure, augmentation index, pulse wave velocity, cardiac output and total peripheral vascular resistance at minutes (-10, 0, +15, +30, +45, +60, +75, +90, +105 and +120).
详细描述
Objectives:
The primary objective of this study is to evaluate the postprandial effect of low and high glycemic index breakfasts on vascular function, measured by central blood pressure, augmentation index and pulse wave velocity, in a sample of healthy young adults. The second objective is to assess the postprandial effect of low and high glycemic index breakfasts on blood glucose and insulin values in a sample of healthy young adults. The third and last objective is to assess the postprandial effect of low and high glycemic index breakfasts on cognitive performance in a sample of healthy young adults.
Design and setting:
A controlled crossover clinical trial, where each subject will complete three interventions (control breakfast, high glycemic index breakfast and low glycemic index breakfast), with a washout period of one week between each, and whose order will be determined by a randomization sequence generated using the Randomization.com software (http://www.randomization.com).
Study setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults.
- •Aged between 20 and 40 years.
- •Both sexes.
- •Those agree to sign the informed consent.
排除标准
- •History of cardiovascular events (acute myocardial infarction, stroke, etc.).
- •History of hypertension, diabetes mellitus or dyslipidemia.
- •Pharmacological treatment for any of the above conditions.
- •Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.
- •Excessive consumption of toxic substances.
- •Celiac patients and/or those intolerant to lactose.
- •Subjects on a low-calorie and/or low-sodium diet.
- •Pregnant women.
- •Those with any other circumstance that the investigators consider could interfere with the study procedures.
结局指标
主要结局
Augmentation index
时间窗: Changes in augmentation index at 1 week, according to glycemic index of the breakfast
Measurement by Mobil-O-Graph® device
次要结局
- Central blood pressure(Changes in central blood pressure at 1 week, according to glycemic index of the breakfast)
- Delayed verbal memory(Changes in delayed verbal memory at 1 week, according to glycemic index of the breakfast)
- Pulse wave velocity(Changes in pulse wave velocity at 1 week, according to glycemic index of the breakfast)
- Blood glucose(Changes in blood glucose at 1 week, according to glycemic index of the breakfast)
- Insulin values(Changes in insulin values at 1 week, according to glycemic index of the breakfast)
- Immediate verbal memory(Changes in immediate verbal memory at 1 week, according to glycemic index of the breakfast)
- Phonological fluency(Changes in phonological fluency at 1 week, according to glycemic index of the breakfast)
- Attention(Changes in attention at 1 week, according to glycemic index of the breakfast)
- Sustained attention(Changes in sustained attention at 1 week, according to glycemic index of the breakfast)
- Selective attention(Changes in selective attention at 1 week, according to glycemic index of the breakfast)
- Processing speed(Changes in processing speed at 1 week, according to glycemic index of the breakfast)
- Executive functions(Changes in executive functions at 1 week, according to glycemic index of the breakfast)
- Working memory(Changes in working memory at 1 week, according to glycemic index of the breakfast)