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
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.
Trial website
https://clinicaltrials.gov/study/NCT00421616
Trial related presentations / publications
Tan SY, Batterham M, Tapsell L. Activity counts from accelerometers do not add value to energy expenditure predictions in sedentary overweight individuals during weight loss interventions. J Phys Act Health. 2011 Jul;8(5):675-81. doi: 10.1123/jpah.8.5.675.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00421616