Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000324314
Ethics application status
Approved
Date submitted
26/06/2008
Date registered
14/07/2008
Date last updated
14/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of breakfast on children's cogntion and satiety.
Scientific title
Acute studies of meals high in dairy foods in children - effects on cognition and satiety
Secondary ID [1] 612 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic response. 3317 0
Condition category
Condition code
Diet and Nutrition 3477 3477 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three beverages that differ in gylcaemic load (GL) and dairy composition.
Beverage 1 (High GL/No dairy)- Glucose 65g, water, flavouring
Beverage 2 (Medium GL, medium dairy) - Whole milk 200ml, water, sweetener, flavouring
Beverage 3 (Low GL/High dairy) - Whole milk 400ml, non-nutritive sweetener, flavouring.
The participants will consume each of the three beverages over 3 consecutive days - i.e. Beverage 1 on day 1, Beverage 2 on day 2 and Beverage 3 on day 3 (randomised). Frequency of intake is once per day (consumed at 0900), for 3 days.
Intervention code [1] 3056 0
Lifestyle
Comparator / control treatment
No control - crossover design. Each participant will have all 3 beverages (as described above) over 3 consecutive days.
Control group
Active

Outcomes
Primary outcome [1] 4450 0
Speed of Processing - Inspection Time (Burns & Nettelbeck, 2003)
Timepoint [1] 4450 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Primary outcome [2] 4451 0
Simple Reaction Time - computerised task Danthiir (2005, unpublished thesis). A known stimulus (e.g. the number 1) is presented in a known location (e.g. middle of computer screen), at variable time intervals. The participant responds by pressing a specific key (e.g. the space bar). The dependent variable is the time take (msec) to respond after presentation.
Timepoint [2] 4451 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days
Primary outcome [3] 4452 0
Choice Reaction Time - computerised task
Danthiir (2005, unpublished thesis). One of two known stimuli (e.g. the numbers 1 or 2) are presented in a known location (e.g. middle of computer screen). The participant is required to respond by pressing a specific key for each stimulus. The dependent variable is the time taken (msec) to respond after presentation.
Timepoint [3] 4452 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Secondary outcome [1] 7390 0
Speed of Processing - Digit Symbol Coding (WISC-IV).
(Wechsler, 2003).
Timepoint [1] 7390 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Secondary outcome [2] 7391 0
Short Term Memory. Computerised version of the Rey Auditory Verbal Learning Test (RAVLT). (Rey, 1964).
Timepoint [2] 7391 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Secondary outcome [3] 7392 0
Working Memory - Digit Span Backwards. Computerised version of WISC-IV subtest.
(Weschler, 2003).
Timepoint [3] 7392 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Secondary outcome [4] 7393 0
Satiety. Computer-based visual-analogue scale.
Timepoint [4] 7393 0
Baseline and at 1h, 2h, and 3h post beverage consumption for three consecutive days.
Secondary outcome [5] 7394 0
Blood Glucose. Using Continuous Glucose Monitoring System (CGMS). (Medtronic, 2005).
Timepoint [5] 7394 0
Continuously from 0800h to 1330h for three consecutive days. The beverage is consumed at 0900, so glucose will be measured for 1 hour prior to beverage consumption (baseline) and for 4.5 hours post beverage consumption.

Eligibility
Key inclusion criteria
Children aged 10-12 years.
Willing to attend on four mornings in one week of the school holidays.
Willing to attend fasted (from midnight of previous day).
Willing to undertake Continous Glucose Monitoring.
Informed child and parental consent.
Parent judgement about child's ability to complete congitive 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.

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)
Participants will be allocated to conditions by computer program (www.randomization.com)/
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2008
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)
Recruitment postcode(s) [1] 940 0
Adelaide metropolitan

Funding & Sponsors
Funding source category [1] 3521 0
Commercial sector/Industry
Name [1] 3521 0
Dairy Innovation Australia Limited
Country [1] 3521 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] 3160 0
None
Name [1] 3160 0
Address [1] 3160 0
Country [1] 3160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5558 0
CSIRO Human Nutrition Human Research Ethics Committee (HREC)
Ethics committee address [1] 5558 0
Gate 13, Kintore Avenue, Adelaide SA 5000
Ethics committee country [1] 5558 0
Australia
Date submitted for ethics approval [1] 5558 0
22/02/2008
Approval date [1] 5558 0
09/04/2008
Ethics approval number [1] 5558 0
08/07

Summary
Brief summary
The aim of the study is to examine the effect of dairy consumption on satiety and certain aspects of cognition in a sample of primary school children aged 10-12 years. It is hypothesized that beverages with a lower glycaemic load and higher dairy composition will be associated with improvements in measures of cognitive function and satiety compared to beverages high in gylcaemic load and containing no dairy food.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28703 0
Address 28703 0
Country 28703 0
Phone 28703 0
Fax 28703 0
Email 28703 0
Contact person for public queries
Name 11860 0
Dr Amy Slater
Address 11860 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 11860 0
Australia
Phone 11860 0
08 8305 0611
Fax 11860 0
08 8303 8899
Email 11860 0
[email protected]
Contact person for scientific queries
Name 2788 0
Associate Professor Manny Noakes
Address 2788 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 2788 0
Australia
Phone 2788 0
08 8303 8827
Fax 2788 0
08 8303 8899
Email 2788 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

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