Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00421616




Registration number
NCT00421616
Ethics application status
Date submitted
11/01/2007
Date registered
12/01/2007
Date last updated
19/02/2007

Titles & IDs
Public title
Effectiveness of High Protein Diets 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.
Secondary ID [1] 0 0
HE06/332
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight & anthropometric measurements at 0 and 3 months
Timepoint [1] 0 0
Primary outcome [2] 0 0
Energy expenditure
Timepoint [2] 0 0
Primary outcome [3] 0 0
Substrate oxidation
Timepoint [3] 0 0
Primary outcome [4] 0 0
Compliance to diets
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Blood lipids
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Appetite
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Overweight or obese
* Age 18 and above
* Both males and females
* Live in Illawarra Area of Australia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Regular medication
* Smoker
* Food allergies
* Presence of disease 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Smart Foods Centre, University of Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2522 - Wollongong

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wollongong
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Centre of Excellence in Functional Foods, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Marijka Batterham, PhD
Address 0 0
Smart Foods Centre, University of Wollongong
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marijka Batterham, PhD
Address 0 0
Country 0 0
Phone 0 0
+61242215303
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00421616