Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000140954
Ethics application status
Approved
Date submitted
4/02/2011
Date registered
7/02/2011
Date last updated
7/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to compare the effect breakfast cereals differing in fibre content on short-term appetite and mood in 8-12yo children
Scientific title
Breakfast in Children Study 2010:A randomised controlled trial to compare the effect breakfast cereals differing in fibre content on short-term appetite and mood in 8-12yo children
Secondary ID [1] 253564 0
None
Universal Trial Number (UTN)
Trial acronym
KG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and Nutrition 261096 0
Condition category
Condition code
Diet and Nutrition 259228 259228 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will employ a four-way repeated measures crossover design. All participants will encounter each breakfast type ,breakfast cereals,high fibre, moderate, moderate-low and low fibre.once for each of the four intervention periods.They will be administered to measure their effect on satiety over a 4 hour period across the morning and energy intake at mid-morning .The study will be conducted in the same children in 2 consecutive weekly periods covering 2 of the test interventions per week. The interventions will be randomised such that each child may be equally likely to receive any one of the 4 interventions on any of the 4 testing occasions.The participants will follow their habitual diet for the period between the four test interventions.
Intervention code [1] 257960 0
Lifestyle
Comparator / control treatment
The study will be conducted in the same children in 2 consecutive weekly periods covering 2 of the test interventions per week. The interventions will be randomised such that each child may be equally likely to receive any one of the 4 interventions on any of the 4 testing occasions. Low fibre cereal will be used as the control treatment.The participants will follow their habitual diet for the period between the four test interventions.
Control group
Active

Outcomes
Primary outcome [1] 262084 0
The primary objective of this study is to compare the effect a very high fibre cereal to a low fibre breakfast cereal on subjective measures of fullness and appetite two and four hours after breakfast and ad libitum intake two hours after breakfast.This will be measured over a 4 hour period using a computer programme involving a series of visual analogue scales .
Timepoint [1] 262084 0
Four dietary conditions will be administered to measure their effect on satiety over a 4 hour period across 4 seperate mornings.
Secondary outcome [1] 273123 0
The secondary objective is to compare the effect of a very high fibre cereal to a low fibre breakfast cereal on subjective measures of mood two and four hours after breakfast and ad libitum intake two hours after breakfast.Questionnaires will be used to assess the subjective measures of mood.
Timepoint [1] 273123 0
Four dietary conditions will be administered to measure their effect on satiety over a 4 hour period across 4 seperate mornings.

Eligibility
Key inclusion criteria
8-12 years old,willingness to attend CSIRO Clinic on 4 mornings in two weeks of the school holidays,willingness to attend CSIRO Clinic in fasted state,ability to complete all satiety testing requirements , good general health,regular breakfast consumer defined as more than 5 times per week,regular consumer of ready to eat cereal and willingness to consume in study,ability to follow verbal and written instructions in English,Ability to give informed consent.
Minimum age
8 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,not a regular breakfast eater,poor general health,learning disabilities or reading difficulties,attention deficit disorder,acute illness within a week prior to testing,current medication usage,known to be allergic to cereal and or dairy foods or considered lactose intolerant,unwilling to consume nominated test cereals,BMI in obese category for age and height,diagnosed as having Type 1 diabetes,learning difficulties or attention deficit hyperactivity disorder .

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258448 0
Commercial sector/Industry
Name [1] 258448 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 258448 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Commonwealth Scientific Industrial Research Organisation
Address
Gate 13
Kintore Ave
Adelaide
SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 257593 0
None
Name [1] 257593 0
Address [1] 257593 0
Country [1] 257593 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 32161 0
Address 32161 0
Country 32161 0
Phone 32161 0
Fax 32161 0
Email 32161 0
Contact person for public queries
Name 15408 0
Dr Emily Brindal
Address 15408 0
Gate 13
Kintore Ave
Adelaide
SA 5000
Australia
Country 15408 0
Australia
Phone 15408 0
+61 8 83050633
Fax 15408 0
Email 15408 0
[email protected]
Contact person for scientific queries
Name 6336 0
Dr Emily Brindal
Address 6336 0
Gate 13
Kintore Ave
Adelaide
SA 5000
Australia
Country 6336 0
Australia
Phone 6336 0
+61 8 83050633
Fax 6336 0
Email 6336 0
+61 8 83050633

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.