HealthyBGINCT02616276
Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance (BGI Study)
A study testing High glycemic index breakfast and Low glycemic index breakfast in people with Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High glycemic index breakfast and Low glycemic index breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults.
- Aged between 20 and 40 years.
- Both sexes.
- Those agree to sign the informed consent.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Salamanca, 37003
About this study
Official title: Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance, a Crossover Clinical Trial (BGI Study)
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).
Read the 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.
- Conditions
- Healthy
- Being tested
- Control breakfast, High glycemic index breakfast, Low glycemic index breakfast
- Keywords
- Glycemic Index, Postprandial Period, Vascular Stiffness, Blood glucose, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control breakfastOther
Also called BF-1
It consists of 350 ml of water at room temperature.
High glycemic index breakfastOther
Also called BF-2
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 breakfastOther
Also called BF-3
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control breakfast Receives: Other: Control breakfast; Other: High glycemic index breakfast; Other: Low glycemic index breakfast |
| Intervention 1 | Experimental | High glycemic index breakfast Receives: Other: Control breakfast; Other: High glycemic index breakfast; Other: Low glycemic index breakfast |
| Intervention 2 | Experimental | Low glycemic index breakfast Receives: Other: Control breakfast; Other: High glycemic index breakfast; Other: Low glycemic index breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmentation index
Measurement by Mobil-O-Graph® device
Measured: Changes in augmentation index at 1 week, according to glycemic index of the breakfast
Secondary outcomes (13)
Central blood pressure
Measurement by Mobil-O-Graph® device
Measured: Changes in central blood pressure at 1 week, according to glycemic index of the breakfast
Pulse wave velocity
Measurement by Mobil-O-Graph® device
Measured: Changes in pulse wave velocity at 1 week, according to glycemic index of the breakfast
Blood glucose
Measurement by laboratory test sampling
Measured: Changes in blood glucose at 1 week, according to glycemic index of the breakfast
Insulin values
Measurement by laboratory test sampling
Measured: Changes in insulin values at 1 week, according to glycemic index of the breakfast
Immediate verbal memory
Assessment by immediate recall of a list of 15 words, in three attempts
Measured: Changes in immediate verbal memory at 1 week, according to glycemic index of the breakfast
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
Measured: Changes in delayed verbal memory at 1 week, according to glycemic index of the breakfast
Phonological fluency
Assessment by enumerating for one minute as many words as possible starting with different letters
Measured: Changes in phonological fluency at 1 week, according to glycemic index of the breakfast
Attention
Assessment by Trail Making Test A
Measured: Changes in attention at 1 week, according to glycemic index of the breakfast
Processing speed
Assessment by Trail Making Test B
Measured: Changes in processing speed at 1 week, according to glycemic index of the breakfast
Executive functions
Assessment by Trail Making Test B
Measured: Changes in executive functions at 1 week, according to glycemic index of the breakfast
Working memory
Assessment by WAIS Digit Span Backward test
Measured: Changes in working memory at 1 week, according to glycemic index of the breakfast
Sustained attention
Assessment by Stroop test
Measured: Changes in sustained attention at 1 week, according to glycemic index of the breakfast
Selective attention
Assessment by Stroop test
Measured: Changes in selective attention at 1 week, according to glycemic index of the breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616276
- Sponsor's protocol ID
- GRS 1192/B/15
- Acronym
- BGI
- Status last verified
- Mar 2017
- First submitted
- 19 Nov 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27776536
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Effect of Breakfast Glycemic Index on Vascular Function, Insulinemia and Cognitive Performance, a Crossover Clinical Trial (BGI Study)
- ClinicalTrials.gov ID
- NCT02616276
- Acronym / sponsor ID
- BGI / GRS 1192/B/15
- Conditions
- Healthy
- Keywords
- Glycemic Index, Postprandial Period, Vascular Stiffness, Blood glucose, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfastControl breakfast |
| Intervention 1 | Experimental | Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfastHigh glycemic index breakfast |
| Intervention 2 | Experimental | Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfastLow glycemic index breakfast |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young adults.
- Aged between 20 and 40 years.
- Both sexes.
- Those agree to sign the informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control breakfastAlso: BF-1It consists of 350 ml of water at room temperature. | Other | Control, Intervention 1, Intervention 2 |
| High glycemic index breakfastAlso: BF-2It 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. | Other | Control, Intervention 1, Intervention 2 |
| Low glycemic index breakfastAlso: BF-3It 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 | Control, Intervention 1, Intervention 2 |
Primary outcome
Augmentation index
Time frame: Changes in augmentation index at 1 week, according to glycemic index of the breakfast
Measurement by Mobil-O-Graph® device
13 secondary outcomes
Central blood pressure
Time frame: Changes in central blood pressure at 1 week, according to glycemic index of the breakfast
Pulse wave velocity
Time frame: Changes in pulse wave velocity at 1 week, according to glycemic index of the breakfast
Blood glucose
Time frame: Changes in blood glucose at 1 week, according to glycemic index of the breakfast
Insulin values
Time frame: Changes in insulin values at 1 week, according to glycemic index of the breakfast
Immediate verbal memory
Time frame: Changes in immediate verbal memory at 1 week, according to glycemic index of the breakfast
Delayed verbal memory
Time frame: Changes in delayed verbal memory at 1 week, according to glycemic index of the breakfast
Phonological fluency
Time frame: Changes in phonological fluency at 1 week, according to glycemic index of the breakfast
Attention
Time frame: Changes in attention at 1 week, according to glycemic index of the breakfast
Processing speed
Time frame: Changes in processing speed at 1 week, according to glycemic index of the breakfast
Executive functions
Time frame: Changes in executive functions at 1 week, according to glycemic index of the breakfast
Working memory
Time frame: Changes in working memory at 1 week, according to glycemic index of the breakfast
Sustained attention
Time frame: Changes in sustained attention at 1 week, according to glycemic index of the breakfast
Selective attention
Time frame: Changes in selective attention at 1 week, according to glycemic index of the breakfast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 27776536Sanchez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High glycemic index breakfast and Low glycemic index breakfast in people with Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Augmentation index (time frame: Changes in augmentation index at 1 week, according to glycemic index of the breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.