Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance (BGI Study)
NCT ID: NCT02616276
Last Updated: 2017-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-12-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Control
Control breakfast
Control breakfast
It consists of 350 ml of water at room temperature.
High glycemic index breakfast
It consists of 350 ml of water at room temperature, 200 ml of grape juice (with 136.28 kcal), 40 g of white bread (2 slices of 52.2 kcal each) and 29 g of strawberry jam (with 127.52 kcal); providing a total of 368.2 kcal.
Low glycemic index breakfast
It consists of 350 ml of water at room temperature, a 150 g apple (with 81.12 kcal), a 125 g low-fat natural yogurt (with 56.10 kcal), 3 shelled walnuts (with 38.94 kcal per unit) and 17.5 g of 72% black chocolate (with 102 kcal); supplying a total of 356.04 kcal.
Intervention 1
High glycemic index breakfast
Control breakfast
It consists of 350 ml of water at room temperature.
High glycemic index breakfast
It consists of 350 ml of water at room temperature, 200 ml of grape juice (with 136.28 kcal), 40 g of white bread (2 slices of 52.2 kcal each) and 29 g of strawberry jam (with 127.52 kcal); providing a total of 368.2 kcal.
Low glycemic index breakfast
It consists of 350 ml of water at room temperature, a 150 g apple (with 81.12 kcal), a 125 g low-fat natural yogurt (with 56.10 kcal), 3 shelled walnuts (with 38.94 kcal per unit) and 17.5 g of 72% black chocolate (with 102 kcal); supplying a total of 356.04 kcal.
Intervention 2
Low glycemic index breakfast
Control breakfast
It consists of 350 ml of water at room temperature.
High glycemic index breakfast
It consists of 350 ml of water at room temperature, 200 ml of grape juice (with 136.28 kcal), 40 g of white bread (2 slices of 52.2 kcal each) and 29 g of strawberry jam (with 127.52 kcal); providing a total of 368.2 kcal.
Low glycemic index breakfast
It consists of 350 ml of water at room temperature, a 150 g apple (with 81.12 kcal), a 125 g low-fat natural yogurt (with 56.10 kcal), 3 shelled walnuts (with 38.94 kcal per unit) and 17.5 g of 72% black chocolate (with 102 kcal); supplying a total of 356.04 kcal.
Interventions
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Control breakfast
It consists of 350 ml of water at room temperature.
High glycemic index breakfast
It consists of 350 ml of water at room temperature, 200 ml of grape juice (with 136.28 kcal), 40 g of white bread (2 slices of 52.2 kcal each) and 29 g of strawberry jam (with 127.52 kcal); providing a total of 368.2 kcal.
Low glycemic index breakfast
It consists of 350 ml of water at room temperature, a 150 g apple (with 81.12 kcal), a 125 g low-fat natural yogurt (with 56.10 kcal), 3 shelled walnuts (with 38.94 kcal per unit) and 17.5 g of 72% black chocolate (with 102 kcal); supplying a total of 356.04 kcal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 20 and 40 years.
* Both sexes.
* Those agree to sign the informed consent.
Exclusion Criteria
* 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.
20 Years
40 Years
ALL
Yes
Sponsors
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Castilla-León Health Service
OTHER
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
OTHER
Responsible Party
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Locations
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Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Salamanca, Spain
Countries
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References
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Sanchez-Aguadero N, Garcia-Ortiz L, Patino-Alonso MC, Mora-Simon S, Gomez-Marcos MA, Alonso-Dominguez R, Sanchez-Salgado B, Recio-Rodriguez JI. Postprandial effect of breakfast glycaemic index on vascular function, glycaemic control and cognitive performance (BGI study): study protocol for a randomised crossover trial. Trials. 2016 Oct 24;17(1):516. doi: 10.1186/s13063-016-1649-x.
Other Identifiers
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GRS 1192/B/15
Identifier Type: -
Identifier Source: org_study_id
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