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

Healthy Clinical Trial

— BGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616276
• Other study ID #: GRS 1192/B/15
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: March 16, 2017
• Start date: December 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Primary Care Research Unit - The Alamedilla Center for Health	Salamanca

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Augmentation index	Measurement by Mobil-O-Graph® device	Changes in augmentation index at 1 week, according to glycemic index of the breakfast
Secondary	Central blood pressure	Measurement by Mobil-O-Graph® device	Changes in central blood pressure at 1 week, according to glycemic index of the breakfast
Secondary	Pulse wave velocity	Measurement by Mobil-O-Graph® device	Changes in pulse wave velocity at 1 week, according to glycemic index of the breakfast
Secondary	Blood glucose	Measurement by laboratory test sampling	Changes in blood glucose at 1 week, according to glycemic index of the breakfast
Secondary	Insulin values	Measurement by laboratory test sampling	Changes in insulin values at 1 week, according to glycemic index of the breakfast
Secondary	Immediate verbal memory	Assessment by immediate recall of a list of 15 words, in three attempts	Changes in immediate verbal memory at 1 week, according to glycemic index of the breakfast
Secondary	Delayed verbal memory	Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes	Changes in delayed verbal memory at 1 week, according to glycemic index of the breakfast
Secondary	Phonological fluency	Assessment by enumerating for one minute as many words as possible starting with different letters	Changes in phonological fluency at 1 week, according to glycemic index of the breakfast
Secondary	Attention	Assessment by Trail Making Test A	Changes in attention at 1 week, according to glycemic index of the breakfast
Secondary	Processing speed	Assessment by Trail Making Test B	Changes in processing speed at 1 week, according to glycemic index of the breakfast
Secondary	Executive functions	Assessment by Trail Making Test B	Changes in executive functions at 1 week, according to glycemic index of the breakfast
Secondary	Working memory	Assessment by WAIS Digit Span Backward test	Changes in working memory at 1 week, according to glycemic index of the breakfast
Secondary	Sustained attention	Assessment by Stroop test	Changes in sustained attention at 1 week, according to glycemic index of the breakfast
Secondary	Selective attention	Assessment by Stroop test	Changes in selective attention at 1 week, according to glycemic index of the breakfast