Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000126415
Ethics application status
Approved
Date submitted
5/02/2007
Date registered
12/02/2007
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing evidence for the functional properties of a whole grain in weight management.
Scientific title
The effect of inclusion of foods high in beta-glucan in an energy restricted diet on weight loss in overweight females.
Secondary ID [1] 343 0
Associated with Australian Research Council grant: LP0561586
Universal Trial Number (UTN)
Trial acronym
FISA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 1618 0
Condition category
Condition code
Diet and Nutrition 1726 1726 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 month randomised dietary intervention trial where all subjects receive weight reduction (energy restriction) advice. The advice is delivered by an Accredited Practising Dietitian in an individual consultation at commencement of the study. The dietitian will also review the participant at one and two months at a further face to face consultation. Intervention patients receive identical advice and the same products but enriched with beta-glucan. The intervention participants are in two groups - moderate (4-5 g beta-glucan/day) and high (7-8 g beta-glucan/day). All subjects are blinded to their control/intervention group status.
Intervention code [1] 1573 0
Treatment: Other
Comparator / control treatment
3 month randomised dietary intervention trial where all subjects receive weight reduction (energy restriction) advice. The advice is delivered by an Accredited Practising Dietitian in an individual consultation at commencement of the study. The dietitian will also review the participant at one and two months at a further face to face consultation. Control patients receive advice on an energy-restricted diet plus low kilojoule breakfast cereals and cereal based snack bars with negligible beta-glucan (placebo).
Control group
Placebo

Outcomes
Primary outcome [1] 2397 0
Weight
Timepoint [1] 2397 0
Measured at 0, 1, 2 and 3 months.
Secondary outcome [1] 4164 0
Percentage body fat, waist circumference, dietary compliance
Timepoint [1] 4164 0
Measured at 0, 1, 2 and 3 months.
Secondary outcome [2] 4165 0
Cholesterol
Timepoint [2] 4165 0
Measured at 0 and 3 months.

Eligibility
Key inclusion criteria
Overweight (BMI 25-32), non-smoker, nil significant health conditions (or regular medications relevant to weight/cholesterol/diabetes), English speaking.
Minimum age
19 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Menopausal women under 45; diagnosed diabetes, renal impairment or digestive disorder; individuals with food allergies.

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)
allocation involved contacting the holder of the allocation schedule at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated sequence using random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects blinded to intervention
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1875 0
Government body
Name [1] 1875 0
Australian Research Council
Country [1] 1875 0
Australia
Primary sponsor type
University
Name
School of Health Sciences, University of Wollongong
Address
Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 1690 0
Commercial sector/Industry
Name [1] 1690 0
Uncle Toby's P/L
Address [1] 1690 0
CPW Oceania - Uncle Tobys Cereals R&D
Rutherglen, Victoria.
Country [1] 1690 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3500 0
University of Wollongong
Ethics committee address [1] 3500 0
Ethics committee country [1] 3500 0
Australia
Date submitted for ethics approval [1] 3500 0
Approval date [1] 3500 0
27/11/2006
Ethics approval number [1] 3500 0
HR06/311

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

Contacts
Principal investigator
Name 27507 0
Address 27507 0
Country 27507 0
Phone 27507 0
Fax 27507 0
Email 27507 0
Contact person for public queries
Name 10762 0
Eleanor Beck
Address 10762 0
School of Health Sciences
University of Wollongong
Wollongong NSW 2522
Country 10762 0
Australia
Phone 10762 0
0408266832
Fax 10762 0
+61 2 42214096
Email 10762 0
[email protected]
Contact person for scientific queries
Name 1690 0
Eleanor Beck
Address 1690 0
School of Health Sciences
University of Wollongong
Wollongong NSW 2522
Country 1690 0
Australia
Phone 1690 0
0408266832
Fax 1690 0
+61 2 42214096
Email 1690 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.