Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000530527
Ethics application status
Approved
Date submitted
21/12/2006
Date registered
22/12/2006
Date last updated
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of high protein diets differing in protein source in promoting weight loss in overweight and obese subjects.
Scientific title
A diet higher in animal-based protein is more effective in promoting weight loss in overweight and obese individuals than other protein based diets.
Universal Trial Number (UTN)
Trial acronym
HiP-HOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 1501 0
Condition category
Condition code
Diet and Nutrition 1599 1599 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to hypoenergetic high-protein diets (30% of energy) for 3 months. High protein diet will be prescribed based on the Australian Guide to Healthy Eating using a whole-food approach.
Intervention code [1] 1518 0
Lifestyle
Comparator / control treatment
Participants will be randomised to hypoenergetic standard protein diet (18% of energy) weight loss diet for 3 months.
Control group
Active

Outcomes
Primary outcome [1] 2205 0
Weight and anthropometric measurements
Timepoint [1] 2205 0
At 0 and 3 months (post-intervention)
Primary outcome [2] 2206 0
Energy expenditure and substrate utilisation
Timepoint [2] 2206 0
At 0 and 3 months
Primary outcome [3] 2207 0
Compliance to the test diets
Timepoint [3] 2207 0
3 months
Secondary outcome [1] 3848 0
Lipids
Timepoint [1] 3848 0
At 0 and 3 months
Secondary outcome [2] 3849 0
Appetite
Timepoint [2] 3849 0
At 0 and 3 months

Eligibility
Key inclusion criteria
Overweight and obese (BMI>25 kgm-2), generally well.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Regular medication, smoker, food allergies, presence of diseases which may alter metabolic rate.

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)
This will be done at central administration where the allocation schedule is held.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be done using a computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects of the study will be blinded
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1743 0
Government body
Name [1] 1743 0
National Centre of Excellence in Functional Foods
Country [1] 1743 0
Australia
Primary sponsor type
University
Name
Smart Foods Centre
Address
University of Wollongong, Northfields Ave, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 1538 0
None
Name [1] 1538 0
Nil
Address [1] 1538 0
Country [1] 1538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3221 0
University of Wollongong
Ethics committee address [1] 3221 0
Ethics committee country [1] 3221 0
Australia
Date submitted for ethics approval [1] 3221 0
Approval date [1] 3221 0
Ethics approval number [1] 3221 0
HE06/332

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

Contacts
Principal investigator
Name 27452 0
Address 27452 0
Country 27452 0
Phone 27452 0
Fax 27452 0
Email 27452 0
Contact person for public queries
Name 10707 0
Ms. Cassandra Quick
Address 10707 0
Smart Foods Centre,
University of Wollongong,
Building 39 Northfields Avenue,
Wollongong New South Wales 2522
Country 10707 0
Australia
Phone 10707 0
+612 4221 5124
Fax 10707 0
+612 42214844
Email 10707 0
[email protected]
Contact person for scientific queries
Name 1635 0
Dr. Marijka Batterham
Address 1635 0
Smart Foods Centre,
University of Wollongong,
Building 39 Northfields Avenue,
Wollongong New South Wales 2522
Country 1635 0
Australia
Phone 1635 0
+612 42215303
Fax 1635 0
+612 42214844
Email 1635 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.