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Trial registered on ANZCTR


Registration number
ACTRN12613000248763
Ethics application status
Approved
Date submitted
28/02/2013
Date registered
4/03/2013
Date last updated
4/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The 2-hour effects of whole-grain wheat in women with overweight or obesity
Scientific title
The effects of whole-grain wheat on postprandial biological markers in Australian women at risk of metabolic dysfunction: a randomised cross-over trial
Secondary ID [1] 282038 0
Nil
Universal Trial Number (UTN)
U1111-1139-9695
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial metabolic dysfunction 288493 0
Condition category
Condition code
Metabolic and Endocrine 288840 288840 0 0
Metabolic disorders
Inflammatory and Immune System 288841 288841 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following an overnight fast, on two separate occasions separated by a one-week washout, one of two randomised interventions will be served, comprising whole-grain wheat ready-to-eat breakfast cereal prepared by either regular or additional processing methods, with low fat milk, standardised to 50g available carbohydrate (approximately 4 biscuits and 300 ml milk).
Intervention code [1] 286626 0
Treatment: Other
Comparator / control treatment
Whole-grain wheat ready-to-eat breakfast cereal (regular processing).
Control group
Active

Outcomes
Primary outcome [1] 288966 0
Postprandial metabolic dysfunction measured by peripheral biological markers of oxidative stress and glycaemic parameters.
Timepoint [1] 288966 0
At 0 time and every 30 minutes to 120 minutes postprandially.
Secondary outcome [1] 301468 0
Postprandial immune dysfunction measured by peripheral biological markers of inflammation.
Timepoint [1] 301468 0
At 0 time and every 30 minutes to 120 minutes postprandially.

Eligibility
Key inclusion criteria
Female
Overweight or obesity by waist circumference >80 cm or BMI > 25-35 kg/m2
Age 30-60 years
Minimum age
30 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with an allergy to wheat, gluten, dairy or lactose.
Pregnancy or lactation.
Smoking.
Liver, kidney or heart disease.
Type 1 diabetes and type 2 diabetes with insulin medication.
The use of any medication for weight loss.
Participants that do not regularly consume breakfast.
Unable to participate for 4-week period, including preliminary information visit and wash-out period.
Excessive exercisers, participating in regular physical activity in excess of moderate intensity and duration.
Participants with obesity caused by genetic factors or medication.
Neurological, endocrinological or other major systemic disease, including malignancy.
Acute illness or current evidence of acute or chronic inflammatory or infective disease; treatment for anaemia within the past 3 months; cirrhosis or chronic hepatitis.

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 enrolled by answering advertisements about the trial, considering the Information to Participants" form, followed by medical and eligibility criteria screening. Once the participant has provided informed consent, allocation concealment will be achieved using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be entered into and analysed by statistical applications using Microsoft Exel and IBM SPSS Statistics (V.19) with the assistance of a statistician where required. Descriptive statistics will include mean, standard deviation or standard error of the mean for all anthropometric and biochemical data collected and analysed for significance using the statistical software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6436 0
3021 - St Albans
Recruitment postcode(s) [2] 6437 0
3000 - Melbourne
Recruitment postcode(s) [3] 6438 0
3030 - Werribee
Recruitment postcode(s) [4] 6439 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 286814 0
University
Name [1] 286814 0
Victoria University
Country [1] 286814 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428
Melbourne Vic 8001
Country
Australia
Secondary sponsor category [1] 285603 0
None
Name [1] 285603 0
Address [1] 285603 0
Country [1] 285603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288881 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 288881 0
Ethics committee country [1] 288881 0
Australia
Date submitted for ethics approval [1] 288881 0
Approval date [1] 288881 0
06/02/2013
Ethics approval number [1] 288881 0
HRETH 12/331

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

Contacts
Principal investigator
Name 38202 0
Prof Lily Stojanovska
Address 38202 0
College of Health and Biomedicine
Victoria University, St Albans Campus, Building 6
PO Box 14428
Melbourne Vic 8001
Country 38202 0
Australia
Phone 38202 0
613 9919 2737
Fax 38202 0
613 9919 2465
Email 38202 0
lily.stojanovska@vu.edu.au
Contact person for public queries
Name 38203 0
Lily Stojanovska
Address 38203 0
College of Health and Biomedicine
Victoria University, St Albans Campus, Building 6
PO Box 14428
Melbourne Vic 8001
Country 38203 0
Australia
Phone 38203 0
613 9919 2737
Fax 38203 0
613 9919 2465
Email 38203 0
lily.stojanovska@vu.edu.au
Contact person for scientific queries
Name 38204 0
Lily Stojanovska
Address 38204 0
College of Health and Biomedicine
Victoria University, St Albans Campus, Building 6
PO Box 14428
Melbourne Vic 8001
Country 38204 0
Australia
Phone 38204 0
613 9919 2737
Fax 38204 0
613 9919 2465
Email 38204 0
lily.stojanovska@vu.edu.au

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.