Skip to content

Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance (BGI Study)

Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance, a Crossover Clinical Trial (BGI Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02616276
Acronym
BGI
Enrollment
40
Registered
2015-11-26
Start date
2015-12-31
Completion date
2017-02-28
Last updated
2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Glycemic Index, Postprandial Period, Vascular Stiffness, Blood glucose, Cognition

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.

Interventions

It consists of 350 ml of water at room temperature.

OTHERHigh 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.

OTHERLow 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.

Sponsors

Castilla-León Health Service
CollaboratorOTHER
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Young adults. * Aged between 20 and 40 years. * Both sexes. * Those agree to sign the informed consent.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Augmentation indexChanges in augmentation index at 1 week, according to glycemic index of the breakfastMeasurement by Mobil-O-Graph® device

Secondary

MeasureTime frameDescription
Pulse wave velocityChanges in pulse wave velocity at 1 week, according to glycemic index of the breakfastMeasurement by Mobil-O-Graph® device
Blood glucoseChanges in blood glucose at 1 week, according to glycemic index of the breakfastMeasurement by laboratory test sampling
Insulin valuesChanges in insulin values at 1 week, according to glycemic index of the breakfastMeasurement by laboratory test sampling
Immediate verbal memoryChanges in immediate verbal memory at 1 week, according to glycemic index of the breakfastAssessment by immediate recall of a list of 15 words, in three attempts
Delayed verbal memoryChanges in delayed verbal memory at 1 week, according to glycemic index of the breakfastAssessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
Phonological fluencyChanges in phonological fluency at 1 week, according to glycemic index of the breakfastAssessment by enumerating for one minute as many words as possible starting with different letters
Central blood pressureChanges in central blood pressure at 1 week, according to glycemic index of the breakfastMeasurement by Mobil-O-Graph® device
Processing speedChanges in processing speed at 1 week, according to glycemic index of the breakfastAssessment by Trail Making Test B
Executive functionsChanges in executive functions at 1 week, according to glycemic index of the breakfastAssessment by Trail Making Test B
Working memoryChanges in working memory at 1 week, according to glycemic index of the breakfastAssessment by WAIS Digit Span Backward test
Sustained attentionChanges in sustained attention at 1 week, according to glycemic index of the breakfastAssessment by Stroop test
Selective attentionChanges in selective attention at 1 week, according to glycemic index of the breakfastAssessment by Stroop test
AttentionChanges in attention at 1 week, according to glycemic index of the breakfastAssessment by Trail Making Test A

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026