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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
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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.
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Secondary ID [1]
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HE06/332
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overweight
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - High protein diet study
Behaviour: High protein diet study
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Weight & anthropometric measurements at 0 and 3 months
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Energy expenditure
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Assessment method [2]
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0
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Timepoint [2]
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Primary outcome [3]
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Substrate oxidation
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Assessment method [3]
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0
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Timepoint [3]
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Primary outcome [4]
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Compliance to diets
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Assessment method [4]
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0
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Timepoint [4]
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0
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Secondary outcome [1]
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Blood lipids
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Assessment method [1]
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0
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Timepoint [1]
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0
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Secondary outcome [2]
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Appetite
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Assessment method [2]
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Timepoint [2]
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Eligibility
Key inclusion criteria
- Overweight or obese
- Age 18 and above
- Both males and females
- Live in Illawarra Area of Australia
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Regular medication
- Smoker
- Food allergies
- Presence of disease which may alter metabolic rate
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Smart Foods Centre, University of Wollongong - Wollongong
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Recruitment postcode(s) [1]
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2522 - Wollongong
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Wollongong
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Centre of Excellence in Functional Foods, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Several studies have reported greater weight loss when following high meat-protein diets but
limited studies have studied high plant-based protein diets. Thus we aim to investigate the
effect of high protein diets in weight management and also to investigate the superior
protein source in achieving this effect. In addition, we aim to develop dietary intervention
strategies that are realistic and sustainable.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00421616
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marijka Batterham, PhD
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Address
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Smart Foods Centre, University of Wollongong
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Marijka Batterham, PhD
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Address
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Country
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Phone
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+61242215303
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00421616
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