Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance (BGI Study)
BGI
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Dec 2015
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 17, 2017
March 1, 2017
6 months
November 19, 2015
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Augmentation index
Measurement by Mobil-O-Graph® device
Changes in augmentation index at 1 week, according to glycemic index of the breakfast
Secondary Outcomes (13)
Central blood pressure
Changes in central blood pressure 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
- +8 more secondary outcomes
Study Arms (3)
Control
ACTIVE COMPARATORControl breakfast
Intervention 1
EXPERIMENTALHigh glycemic index breakfast
Intervention 2
EXPERIMENTALLow glycemic index breakfast
Interventions
It consists of 350 ml of water at room temperature.
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.
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.
Eligibility Criteria
You may qualify if:
- Young adults.
- Aged between 20 and 40 years.
- Both sexes.
- Those agree to sign the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Salamanca, 37003, Spain
Related Publications (1)
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.
PMID: 27776536DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 26, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2016
Study Completion
February 1, 2017
Last Updated
March 17, 2017
Record last verified: 2017-03