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Trial registered on ANZCTR


Registration number
ACTRN12611000654954
Ethics application status
Approved
Date submitted
26/06/2011
Date registered
27/06/2011
Date last updated
28/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of two diets with varying insulin demand on day-long profiles of blood glucose and insulin in lean, young healthy adults
Scientific title
To investigate the day-long profiles of blood glucose and insulin in lean, young healthy adults consuming two diets with varying insulin demand
Secondary ID [1] 262479 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 268170 0
Type 1 diabetes 268171 0
Condition category
Condition code
Metabolic and Endocrine 268301 268301 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this within-subject crossover study, healthy subjects will consume two different diets with varying food insulin index (FII) on two separate occasions. The washout period in between the low FII and high FII diets will be at least 7 days. Each test diet will comprise breakfast, morning snack and lunch, which will be carefully designed to be healthy western diet reflecting adherence to the average adult energy requirement in Australia (energy percentage for carbohydrate 50%, protein 20%, fat 30%). The high FII diet will comprise white bread, yogurt and eggs for breakfast, cookie and Mars bar for morning snack and whole-meal bread, cheese and baked beans for lunch. The low FII diet will comprise grain bread, milk and All-bran cereal for breakfast, walnuts and raisins for morning snack, corn, roast chicken and tortillas for lunch. Both diets will be matched for macronutrient composition, glycemic index and fiber content, but two-fold difference in FII values.

On each occasion, breakfast, snack meal and lunch will be consumed by subjects at 0800, 1100 and 1300 during the 8-hour test session. Finger-prick blood samples will be collected before meal (0 min) and every 30 mins after starting eating the meals and assayed for glucose and insulin.
Intervention code [1] 266833 0
Treatment: Other
Intervention code [2] 266834 0
Prevention
Comparator / control treatment
The iso-energetic diet with low food insulin index (FII = 30) serves as the basis of comparison with the diet with high food insulin index (FII = 65).
Control group
Active

Outcomes
Primary outcome [1] 269043 0
The profile of insulin response measured as the incremental area under the curve (AUC) over the 8 hours period.
Timepoint [1] 269043 0
Measured after an overnight fast (10 ~ 12 hours) and over 8 hours after starting eating the breakfast meal
Secondary outcome [1] 276856 0
The profile of glucose response measured as the incremental area under the curve (AUC) over the 8 hours period.
Timepoint [1] 276856 0
Measured after an overnight fast (10 ~ 12 hours) and over 8 hours after starting eating the breakfast meal

Eligibility
Key inclusion criteria
non-smoking, aged 18~40 years, stable body weight, body mass index 19 - 25 kg/m2, normal glucose tolerance, no known food allergy and no history of eating disorders, regular physical activity
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Eating disorders, individuals using medication that may influence blood glucose profiles, food allergy, abnormal glucose tolerance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
10 healthy subjects will be recruited from the student population of the University of Sydney. Each subject will consume 2 different diets on two separate days in a random order. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation digit-table from statistic book will be used to randomise the order of test diet for each subject.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267305 0
University
Name [1] 267305 0
The Unversity of Sydney
Address [1] 267305 0
Level 4, Molecular and Microbial Biosciences (MMB) building, G08 The University of Sydney, NSW 2006
Country [1] 267305 0
Australia
Primary sponsor type
University
Name
Sydney University Glycemic Index Research Service
Address
Level 4, Molecular and Microbial Biosciences (MMB) building, G08 The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 266371 0
None
Name [1] 266371 0
Address [1] 266371 0
Country [1] 266371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269298 0
Human Research Ethics Committee, the University of Sydney
Ethics committee address [1] 269298 0
Jane Foss Russell Building - G02 The University of Sydney NSW 2006
Ethics committee country [1] 269298 0
Australia
Date submitted for ethics approval [1] 269298 0
Approval date [1] 269298 0
19/06/2008
Ethics approval number [1] 269298 0
06-2008/10950

Summary
Brief summary
In this within-subject crossover study conducted in healthy subjects, we investigate the effect of two diets with high and low insulin demand, as predicted by food insulin index (FII) of the component foods, on day-long profiles of blood glucose and insulin. Two diets will be consumed on two separate occasions and both diets will be matched for macronutrients, fiber and glycemic index.

On each occasion, participants will consume breakfast meal, morning snack and lunch over 8-h testing period. Finger-prick blood sample will be collected every 30 min after starting eating the meal and assayed for glucose and insulin. We hypothesize that the diet with high insulin demand will produce significantly higher insulin profile compared with the diet with low insulin demand even though two diets have the same macronutrient compositions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32796 0
Address 32796 0
Country 32796 0
Phone 32796 0
Fax 32796 0
Email 32796 0
Contact person for public queries
Name 16043 0
Jiansong Bao
Address 16043 0
Room 453, Human Nutrition Unit, Biochemistry Building G08, The University of Sydney, NSW 2006
Country 16043 0
Australia
Phone 16043 0
+61 2 93514672
Fax 16043 0
+61 2 93516022
Email 16043 0
jbao9407@uni.sydney.edu.au
Contact person for scientific queries
Name 6971 0
Professor Jennie Brand-Miller
Address 6971 0
Room 472, Human Nutrition Unit, Biochemistry Building G08, The University of Sydney, NSW 2006
Country 6971 0
Australia
Phone 6971 0
+61 2 93513759
Fax 6971 0
+61 2 93516022
Email 6971 0
jennie.brandmiller@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary