Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000331437
Ethics application status
Approved
Date submitted
14/06/2007
Date registered
20/06/2007
Date last updated
20/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Defining the functional properties of GMP and whey protein study 2007
Scientific title
A 4 week crossover study investigating the effects of whey protein peptides on appetite and food intake in obese individuals
Secondary ID [1] 376 0
Commonwealth Scientific Industrial Research Organisation: hk04a
Universal Trial Number (UTN)
Trial acronym
GW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 1880 0
Condition category
Condition code
Diet and Nutrition 1974 1974 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 day acute study of 50gm each of 4 treatments given as a drink, whey protein, 2 whey protein peptides compared with a glucose control. Participants consume the drink for one day, then there is a wash-out period of 1 week before crossing over to other arm.
Intervention code [1] 1827 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2792 0
Food intake
Timepoint [1] 2792 0
At 3 hours after drink
Secondary outcome [1] 4713 0
Glucose, insulin, appetite hormones.
Timepoint [1] 4713 0
At each visit at times 0, 15, 30, 60 90,120 and 180 minutes.

Eligibility
Key inclusion criteria
•Overweight or obese (BMI>25kg/m2) (This will be calculated for you based on your weight (kg) divided by your height in metres squared).•No recent history (past 3 months) of weight loss or changes to diet or physical activity routine.•Unrestrained eater (i.e. restrained eater questionnaire score >10)
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
•Type 1 or 2 Diabetes•Active liver and kidney disease as noted from medical questionnaire•Current gastrointestinal disease • Past history of gastrointestinal surgery which may affect study outcomes• Hypersensitivity to study foods (milk products)•Medications which affect GI motility or hunger /appetite (e.g.metoclopramide, domperidone and cisapride, anticholinergic drugs (eg atropine), erythromycin)•Unable to comprehend study protocol

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 was concealed when it was done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The people receiving the treatments, administering the treatments, assessing the outcomes and analysing the data are all blinded.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2114 0
Government body
Name [1] 2114 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 2114 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
Country
Australia
Secondary sponsor category [1] 1923 0
Government body
Name [1] 1923 0
Commonwealth Scientific Industrial Research Organisation
Address [1] 1923 0
Country [1] 1923 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3906 0
CSIRO Human Nutrition
Ethics committee address [1] 3906 0
Ethics committee country [1] 3906 0
Australia
Date submitted for ethics approval [1] 3906 0
Approval date [1] 3906 0
10/04/2007
Ethics approval number [1] 3906 0
07/13

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

Contacts
Principal investigator
Name 27641 0
Address 27641 0
Country 27641 0
Phone 27641 0
Fax 27641 0
Email 27641 0
Contact person for public queries
Name 11016 0
Anne McGuffin
Address 11016 0
CSIRO Human Nutrition
PO Box 10041
Gate 13 Kintore Ave
Adealaide BC SA 5000
Country 11016 0
Australia
Phone 11016 0
+61 8 83038988
Fax 11016 0
+61 8 83038899
Email 11016 0
[email protected]
Contact person for scientific queries
Name 1944 0
Jennifer Keogh
Address 1944 0
CSIRO Human Nutrition
PO Box 10041
Gate 13 Kintore Ave
Adealaide BC SA 5000
Country 1944 0
Australia
Phone 1944 0
+61 8 83038907
Fax 1944 0
+61 8 83038899
Email 1944 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.