Plain English Summary
Background and study aims
Maintaining a blood sugar concentration of around 4.5-6 mmol/L is important for the body, especially for fuel supply to areas such as the brain. Insulin is the key hormone involved in the regulation of blood sugar, with an increase in insulin causing glucose to be stored by the body’s cells lowering blood sugar levels. Evidence suggests that young people undergo a period of insulin resistance during puberty, where their body does not respond to insulin as effectively and so higher levels of insulin are needed to maintain blood sugar within a healthy range. Evidence also suggest that this response is exaggerated in girls compared to boys and may be affected by maturity. No studies to date have examined how everyday meals which differ in their glycaemic index (GI; a ranking of how a carbohydrate-containing food affects blood sugar levels) are affected by this period of insulin resistance during puberty. The aim of this study is to compare the effects of a high GI (quickly broken down during digestion, increasing blood sugar) breakfast and a low GI (minimal effect on blood sugar levels) breakfast in adolescent girls and boys.
Who can participate?
Healthy children aged 11-14 years.
What does the study involve?
Participants are allocated to eat two breakfasts in a random order, on separate days, 7 days apart. The high GI breakfast consists of cornflakes, milk, toast and margarine. The low GI breakfast consists of muesli, milk and apple. Each breakfast is matched for energy and macro nutrient (carbohydrate, protein and fat) content for each participant so it provides 1.5 g of carbohydrate per kg body mass. On each study visit before eating the breakfast and then 15, 30, 60 and 120 minutes after breakfast, a fingertip blood sample is taken and so that blood sugar and insulin levels can be measured. The results are then compared between boys and girls for the two types of breakfast.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
1. Charnwood College (UK)
2. Market Bosworth High School (UK)
When is the study starting and how long is it expected to run for?
September 2009 to March 2010
Who is funding the study?
Nottingham Trent University (UK)
Who is the main contact?
Dr Simon Cooper
simon.cooper@ntu.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Dr Simon Cooper
ORCID ID
Contact details
Sport Science Department
Nottingham Trent University
Clifton Lane
Nottingham
NG11 8NS
United Kingdom
+44 1158 488059
simon.cooper@ntu.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Sex differences in adolescents’ glycaemic and insulinaemic responses to high and low glycaemic index breakfasts
Acronym
Study hypothesis
Girls will display a greater insulinaemic response to high and low glycaemic index meals than boys.
Ethics approval(s)
Loughborough University Ethical Advisory Committee, 01/10/2009, ref: R09-P118
Study design
Randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Study setting(s)
School
Study type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Glycaemic and insulinaemic responses
Intervention
Participants are individually, randomly allocated to a trial order using the ‘ABBA’ method. Participants then consumed two breakfasts in the order based upon the allocation process on two separate days spaced 7 days apart.
High GI: Breakfast consists of cornflakes with milk, with white toast and margarine
Low GI: Breakfast consists of muesli with milk and an apple
In both groups, participants are given 15 minutes to consume the breakfasts. Before eating the breakfast and then after 15, 30, 60 and 120 minutes, participants have capillary blood samples taken to test for blood glucose and plasma insulin.
Intervention type
Other
Primary outcome measure
1. Blood glucose concentration is measured using the GOD-PAP method using capillary blood samples at baseline and 15, 30, 60 and 120 minutes following the breakfast in each trial condition
2. Plasma insulin concentration is measured using an ELISA assay on capillary blood samples at baseline and 15, 30, 60 and 120 minutes following the breakfast in each trial condition
Secondary outcome measures
Insulin resistance is measured using HOMA (Homeostatic Model Assessment), calculated using the fasting blood glucose and plasma insulin concentrations collected at baseline.
Overall study start date
01/09/2009
Overall study end date
31/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 11-14 years
2. Healthy
Participant type(s)
Healthy volunteer
Age group
Child
Lower age limit
11 Years
Upper age limit
14 Years
Sex
Both
Target number of participants
50
Participant exclusion criteria
1. Any condition which may make the taking of capillary blood samples problematic
2. Any food allergies or intolerances to the foods provided
Recruitment start date
01/10/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Charnwood College (formerly Garendon High School)
Thorpe Hill
Loughborough
LE11 4SQ
United Kingdom
Study participating centre
Market Bosworth High School
Station Road, Back Lane
Market Bosworth
CV13 0JT
United Kingdom
Sponsor information
Organisation
Institute of Youth Sport
Sponsor details
Sir John Beckwith Centre for Sport
Loughborough University
Loughborough
LE11 3TU
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Nottingham Trent University
Alternative name(s)
NTU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication of the findings of the study in a scientific journal, with a submission expected in September 2016.
Intention to publish date
31/07/2017
Individual participant data (IPD) sharing plan
One of the conditions of the ethical committee approval was that individual level data will not be made available due to the ethical considerations of working with young people. Therefore, this data cannot be made widely available.
IPD sharing plan summary
Not expected to be made available
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/02/2017 | Yes | No |