Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000614695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
7/10/2005
Date last updated
7/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low carbohydrate diets weight loss and heart disease
Scientific title
The effect of low or high carbohydrate weight loss diets on flow mediated dilatation, markers of cardiovascular disease risk, adrenocortical function and blood pressure in participants with metabolic syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 746 0
Condition category
Condition code
Diet and Nutrition 822 822 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High carbohydrate or high protein wnergy restricted diet for 12 weeks.
Intervention code [1] 474 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1054 0
Cardiovascular disease risk markers
Timepoint [1] 1054 0
At baseline, after 12 weeks of weight loss and 52 weeks
Secondary outcome [1] 1962 0
NA
Timepoint [1] 1962 0

Eligibility
Key inclusion criteria
BMI 27-40 kg/m2, Fasting glucose 6 -7 mmol/L and/or triglycerides >1.7mmol/L and/or HDL-C < 0.9 in men <1.0 mmol/L in women.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clinstat computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 910 0
Government body
Name [1] 910 0
CSIRO Human Nutrition
Country [1] 910 0
Australia
Primary sponsor type
Government body
Name
CSIRO Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 769 0
Government body
Name [1] 769 0
CSIRO Human Nutrition
Address [1] 769 0
Country [1] 769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2196 0
Adelaide
Ethics committee address [1] 2196 0
Ethics committee country [1] 2196 0
Australia
Date submitted for ethics approval [1] 2196 0
Approval date [1] 2196 0
Ethics approval number [1] 2196 0

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

Contacts
Principal investigator
Name 36349 0
Address 36349 0
Country 36349 0
Phone 36349 0
Fax 36349 0
Email 36349 0
Contact person for public queries
Name 9663 0
Ms Jennifer Keogh
Address 9663 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Country 9663 0
Australia
Phone 9663 0
+61 3 83038907
Fax 9663 0
+61 3 83038899
Email 9663 0
jennifer.keogh@csiro.au
Contact person for scientific queries
Name 591 0
Ms Jennifer Keogh
Address 591 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Country 591 0
Australia
Phone 591 0
+61 3 83038907
Fax 591 0
+61 3 83038899
Email 591 0
jennifer.keogh@csiro.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.