Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000648820
Ethics application status
Not yet submitted
Date submitted
15/06/2012
Date registered
19/06/2012
Date last updated
19/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Kids High Fibre Breakfast Study
Scientific title
The short-term effect of high fibre breakfast cereal on self-reported digestive health in 8-12 year old children.
Secondary ID [1] 280683 0
nil
Universal Trial Number (UTN)
U1111-1131-8521
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 286711 0
bloating 286732 0
Digestive discomfort 286733 0
Condition category
Condition code
Diet and Nutrition 287007 287007 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 287031 287031 0 0
Normal oral and gastrointestinal development and function
Public Health 287032 287032 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
high fibre breakfast cereal at least 7g fibre per 45g serve of cereal, consumed once a day, for 4 days.
Intervention code [1] 285109 0
Prevention
Comparator / control treatment
no change in dietary habits
Control group
Active

Outcomes
Primary outcome [1] 287341 0
Change in digestive health recorded on self-reported questionnaires written by The Gut Foundation specifically for this project and the target age group in Australia.
Timepoint [1] 287341 0
0,7, and 14 days
Secondary outcome [1] 297947 0
nil
Timepoint [1] 297947 0
nil

Eligibility
Key inclusion criteria
Aged between 8-12.
Male and female
All ethnicities
Parental consent forms completed
No diagnosed coeliac, IBS or IBD disease
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed digestive disease such as IBS, Coeliac Disease, or IBD.
Not of the required age group.
No parental consent

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)
The individual will be enrolled and allocated a number. We will than randomly divide the numbers to control or intervention groups. This will be done using white envelopes with the allocated number concealed inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285448 0
Charities/Societies/Foundations
Name [1] 285448 0
The Gut Foundation
Country [1] 285448 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
THE GUT FOUNDATION
Address
201 Avoca Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 284296 0
Commercial sector/Industry
Name [1] 284296 0
Kellogg
Address [1] 284296 0
41-51 Wentworth Ave, Pagewood, NSW 2019
Country [1] 284296 0
Australia
Other collaborator category [1] 276863 0
Individual
Name [1] 276863 0
Dr Michelle Celander
Address [1] 276863 0
41-51 Wentworth Ave, Pagewood, NSW 2019
Country [1] 276863 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287462 0
University NSW HREC
Ethics committee address [1] 287462 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building
Level 3
University of NSW
NSW 2052
Ethics committee country [1] 287462 0
Australia
Date submitted for ethics approval [1] 287462 0
05/06/2012
Approval date [1] 287462 0
Ethics approval number [1] 287462 0
HC12337

Summary
Brief summary
To evaluate in a free-living setting the digestive health of 8 to 12 year old children and the impact a high fibre breakfast cereal has on their digestive health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34321 0
Address 34321 0
Country 34321 0
Phone 34321 0
Fax 34321 0
Email 34321 0
Contact person for public queries
Name 17568 0
Katherine Collings
Address 17568 0
201 Avoca Street
Randwick
Sydney NSW 2031
Country 17568 0
Australia
Phone 17568 0
+61 (0)2 9398 4067
Fax 17568 0
Email 17568 0
[email protected]
Contact person for scientific queries
Name 8496 0
Katherine Collings
Address 8496 0
201 Avoca Street
Randwick
Sydney NSW 2031
Country 8496 0
Australia
Phone 8496 0
+61 (0)2 9398 4067
Fax 8496 0
Email 8496 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.