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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/NCT00254215




Registration number
NCT00254215
Ethics application status
Date submitted
13/11/2005
Date registered
15/11/2005
Date last updated
28/11/2006

Titles & IDs
Public title
Glycemic Load, Weight Loss and Cardiovascular Disease Risk
Scientific title
The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
Secondary ID [1] 0 0
NHF G02S 0768 - Brand-Miller
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - high protein & low glycemic index diets

Behaviour: high protein & low glycemic index diets
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
weight loss at 12 weeks
Timepoint [1] 0 0
Primary outcome [2] 0 0
Fat loss at 12 weeks
Timepoint [2] 0 0
Primary outcome [3] 0 0
Lean mass change at 12 weeks
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Total cholesterol, LDL and HDL cholesterol change at 12 weeks
Timepoint [1] 0 0
Secondary outcome [2] 0 0
glucose, insulin & measures of insulin sensitivity change at 12 weeks
Timepoint [2] 0 0
Secondary outcome [3] 0 0
TG change at 12 weeks
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Leptin change at 12 weeks
Timepoint [4] 0 0
Secondary outcome [5] 0 0
CRP change at 12 weeks
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- 18-40 years of age BMI >=25 stable weight for 3 months non-vegetarian good
understanding of English
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
medications other than the contraceptive pill weight >150kg (weight limit of DEXA machine)
vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance
pregnancy

-

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
1/03/2002
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
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Meat & Livestock Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Heart Foundation, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the hypothesis that reducing the glycemic load of the diet will improve
changes in body composition and cardio-vascular risk factors. The study compares a
conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load:
changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with
protein, or combining both effects to produce the lowest glycemic load.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00254215
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennie C Brand-Miller, PhD
Address 0 0
University of Sydney
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/NCT00254215