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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/NCT00625235




Registration number
NCT00625235
Ethics application status
Date submitted
19/02/2008
Date registered
28/02/2008
Date last updated
28/02/2008

Titles & IDs
Public title
A High Protein Diet and Weight Maintenance
Scientific title
The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors
Secondary ID [1] 0 0
HREC 2003.046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VLED followed by a high protein or high carbohydrate diet

Other: 1 - High Carbohydrate diet

Other: 2 - High Protein diet


Other interventions: VLED followed by a high protein or high carbohydrate diet
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Body weight
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Cardiovascular risk factors
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- healthy men and women with a BMI >27kg/m2 with co-morbities or BMI >30kg/m2
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- people with Type II diabetes or other endocrine disorders, women who were pregnant or
breastfeeding or planning to become pregnant

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Medicine, Heidelberg Repatriation Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Meat and Livestock Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
An investigation into long term weight maintenance using a high protein or high carbohydrate
diet, after a large and rapid weight loss.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00625235
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00625235