Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000261213
Ethics application status
Approved
Date submitted
16/02/2009
Date registered
14/05/2009
Date last updated
14/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of three different breakfast meals with varying glycaemic load and dairy composition on cognition and satiety in healthy children
Scientific title
Effect of three different breakfast meals with varying glycaemic load and dairy composition on cognition and satiety in healthy children
Secondary ID [1] 808 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic response 4333 0
Condition category
Condition code
Diet and Nutrition 4570 4570 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three breakfast meals that differ in glycaemic load (GL) and dairy composition.
Meal 1 (GL ~ 36/low dairy) - 70g white bread, 10g margarine, 10g vegemite (or 30g diet jam), 200ml sweetened fruit drink, 100ml water
Meal 2 (GL ~ 27/medium dairy) - 35g white bread, 100g yoghurt, 20g cheese, 5g vegemite (or 15g diet jam), 100ml sweetened fruit drink, 100ml water
Meal 3 (GL ~ 21/high dairy) - 35g white bread, 100g yoghurt, 20g cheese, 5g vegemite (or 15g jam), 100ml reduced fat milk, 100ml water.
Food and beverage intake is not controlled for other meals, however there is an overnight 'wash-out' period between interventions.
Intervention code [1] 4062 0
Lifestyle
Comparator / control treatment
No control - crossover design. Each participant will have all 3 meals (as described above) over 3 consecutive days
Control group
Dose comparison

Outcomes
Primary outcome [1] 5451 0
Cognitive functioning tasks will be presented and completed via a computer.
A battery of 8 tests will include:
Speed of Processing: Inspection Time,
Simple Reaction Time,
Choice Reaction Time,
Short Term Memory: Word List, Immediate Recall,
Working Memory: Digit Span Backwards,
Attention: Switching Task,
Speed of Reasoning: Odd-Man-Out Task.
(see outcomes below)
Timepoint [1] 5451 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [1] 9154 0
speed of processing - inspection time
Timepoint [1] 9154 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [2] 9155 0
Simple reaction time - computerised task
Timepoint [2] 9155 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [3] 9156 0
Choice reaction time - computerised task
Timepoint [3] 9156 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [4] 9158 0
Short Term Memory: Word List, Immediate Recall - computerised version of the Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964)
Timepoint [4] 9158 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [5] 9159 0
Working Memory: Digit Span Backwards - computerised version of Wechsler Intelligence Scale for Children (WISC-IV) subtest (Weschler, 2003)
Timepoint [5] 9159 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [6] 9160 0
Satiety - computer-based visual-analogue scale
Timepoint [6] 9160 0
baseline and at 1 hr, 2 hr, and 3 hr post meal consumption for three consecutive days.
Secondary outcome [7] 9161 0
Blood glucose - using continuous glucose monitoring system (CGMS) (Medtronic, 2005)
Timepoint [7] 9161 0
Continuously from 0800h to 1330h for three consecutive days

Eligibility
Key inclusion criteria
children aged 10-12 years.
Willing to attend on four mornings in one week of the school holidays.
Willing to undertake continuous glucose monitoring.
informed child and parental consent.
Parent judgement about child's ability to complete cognitive testing requirements (e.g. ability to comprehend and sustain attention).
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
currently on a prescribed diet of any description.
Known allergy to dairy foods or lactose intolerant.
Type 1 diabetes.
Children with diagnosed learning difficulties.
Children with diagnosed Attention Deficit Hyperactivity Disorder (ADHD).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information session conducted and consent subsequently obtained.

Participants will be randomized to one of the three treatment orders via central randomisation by computer (www.randomization.com).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4505 0
Commercial sector/Industry
Name [1] 4505 0
Dairy Innovation Australia Limited
Country [1] 4505 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Human Nutrition
Address
Gate 13 Kintore Avenue, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4068 0
None
Name [1] 4068 0
Address [1] 4068 0
Country [1] 4068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6566 0
CSIRO Human Nutrition Research Ethics Committee (HREC)
Ethics committee address [1] 6566 0
Ethics committee country [1] 6566 0
Australia
Date submitted for ethics approval [1] 6566 0
Approval date [1] 6566 0
09/04/2008
Ethics approval number [1] 6566 0
08/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29291 0
Address 29291 0
Country 29291 0
Phone 29291 0
Fax 29291 0
Email 29291 0
Contact person for public queries
Name 12538 0
Danielle Klose
Address 12538 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue Adelaide SA 5000
Country 12538 0
Australia
Phone 12538 0
+61 8 8303 8972
Fax 12538 0
+61 8 8303 8899
Email 12538 0
[email protected]
Contact person for scientific queries
Name 3466 0
Associate Professor Manny Noakes
Address 3466 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue, Adelaide SA 5000
Country 3466 0
Australia
Phone 3466 0
+61 8 8303 8827
Fax 3466 0
+61 8 8303 8899
Email 3466 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.