Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance (BGI Study)
- Conditions
- Healthy
- Interventions
- Other: Control breakfastOther: High glycemic index breakfastOther: Low glycemic index breakfast
- Registration Number
- NCT02616276
- Lead Sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Brief Summary
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).
- Detailed Description
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:
The study will be conducted in the primary care health area of Salamanca in the Research Unit of La Alamedilla, belonging to the Spanish Network for Preventive Activities and Health Promotion (redIAPP) and Salamanca Institute for Biomedical Research (IBSAL).
Study population:
The subjects of the study population will be selected by consecutive sampling in the primary care clinics of urban health centers in Salamanca (Spain) between 2015 and 2016. As this crossover clinical trial, a consecutive sampling will ensure comparability of the groups.
Intervention:
Each of the three scheduled visits will last approximately 2 and a half hours, and will be structured as follows:
Min -10: Measurement of clinical blood pressure, central blood pressure, and central hemodynamic parameters; evaluation of cognitive performance; laboratory test sampling to determine glucose and insulin blood levels.
Min 0: Measurement of central blood pressure and central hemodynamic parameters; intake of assigned breakfast (10 minutes).
Min +15, +30, +45: Measurement of central blood pressure and central hemodynamic parameters.
Min +60: Measurement of central blood pressure and central hemodynamic parameters; evaluation of cognitive performance; laboratory test sampling to determine glucose and insulin blood levels.
Min +75, +90, +105: Measurement of central blood pressure and central hemodynamic parameters.
Min +120: Measurement of central blood pressure and central hemodynamic parameters; evaluation of cognitive performance; laboratory test sampling to determine glucose and insulin blood levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Young adults.
- Aged between 20 and 40 years.
- Both sexes.
- Those agree to sign the informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Control breakfast Control breakfast Control Low glycemic index breakfast Control breakfast Intervention 2 Control breakfast Low glycemic index breakfast Intervention 2 Low glycemic index breakfast Low glycemic index breakfast Control High glycemic index breakfast Control breakfast Intervention 1 Control breakfast High glycemic index breakfast Intervention 1 Low glycemic index breakfast High glycemic index breakfast Intervention 1 High glycemic index breakfast High glycemic index breakfast Intervention 2 High glycemic index breakfast Low glycemic index breakfast
- Primary Outcome Measures
Name Time Method Augmentation index Changes in augmentation index at 1 week, according to glycemic index of the breakfast Measurement by Mobil-O-Graph® device
- Secondary Outcome Measures
Name Time Method Central blood pressure Changes in central blood pressure at 1 week, according to glycemic index of the breakfast Measurement by Mobil-O-Graph® device
Delayed verbal memory Changes in delayed verbal memory at 1 week, according to glycemic index of the breakfast Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
Pulse wave velocity Changes in pulse wave velocity at 1 week, according to glycemic index of the breakfast Measurement by Mobil-O-Graph® device
Blood glucose Changes in blood glucose at 1 week, according to glycemic index of the breakfast Measurement by laboratory test sampling
Insulin values Changes in insulin values at 1 week, according to glycemic index of the breakfast Measurement by laboratory test sampling
Immediate verbal memory Changes in immediate verbal memory at 1 week, according to glycemic index of the breakfast Assessment by immediate recall of a list of 15 words, in three attempts
Phonological fluency Changes in phonological fluency at 1 week, according to glycemic index of the breakfast Assessment by enumerating for one minute as many words as possible starting with different letters
Attention Changes in attention at 1 week, according to glycemic index of the breakfast Assessment by Trail Making Test A
Sustained attention Changes in sustained attention at 1 week, according to glycemic index of the breakfast Assessment by Stroop test
Selective attention Changes in selective attention at 1 week, according to glycemic index of the breakfast Assessment by Stroop test
Processing speed Changes in processing speed at 1 week, according to glycemic index of the breakfast Assessment by Trail Making Test B
Executive functions Changes in executive functions at 1 week, according to glycemic index of the breakfast Assessment by Trail Making Test B
Working memory Changes in working memory at 1 week, according to glycemic index of the breakfast Assessment by WAIS Digit Span Backward test
Trial Locations
- Locations (1)
Primary Care Research Unit - The Alamedilla Center for Health
🇪🇸Salamanca, Spain