Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000203550
Ethics application status
Approved
Date submitted
3/05/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term health effects of high and low carbohydrate diets in obese subjects
with the metabolic syndrome
Scientific title
Long-term health effects of high and low carbohydrate, weight loss diets in obese subjects with the metabolic syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1181 0
Condition category
Condition code
Diet and Nutrition 1264 1264 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants will be randomised for the 52 week intervention duration to either;
1. Low carbohydrate diet:35% protein,
61% fat (20% saturated fat)
4% carbohydrate

2. High carbohydrate,low fat diet:18% protein, 27% fat (<8% saturated fat)
55% carbohydrate
Intervention code [1] 1017 0
Lifestyle
Comparator / control treatment
1. Low carbohydrate diet:35% protein,
61% fat (20% saturated fat)
4% carbohydrate
Control group
Active

Outcomes
Primary outcome [1] 1702 0
Weight loss
Timepoint [1] 1702 0
At 8 weeks and 52 weeks after start of diet intervention
Secondary outcome [1] 3054 0
Lipids, insulin, glucose, blood pressure, body composition, flow mediated dilatation, physical function, psychological health, bone health & renal function and nutrition adequacy.
Timepoint [1] 3054 0
At 8 and 52 weeks after start of diet intervention.

Eligibility
Key inclusion criteria
High waist circumferenceat least one cardiovascular risk factor.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have proteinuria, a malignancy, or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease, diabetes (fasting blood glucose or are pregnantUncontrolled hypertension (resting recumbent BP >160/110 mmHg).

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
two dietary patterns
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1383 0
Charities/Societies/Foundations
Name [1] 1383 0
national heart foundation of Australia
Country [1] 1383 0
Australia
Funding source category [2] 1384 0
Government body
Name [2] 1384 0
national health & medical research council of Australia
Country [2] 1384 0
Australia
Primary sponsor type
Government body
Name
national health & medical research council of Australia
Address
Country
Australia
Secondary sponsor category [1] 1218 0
Charities/Societies/Foundations
Name [1] 1218 0
national heart foundation
Address [1] 1218 0
Country [1] 1218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2734 0
CSIRO Human Nutrition
Ethics committee address [1] 2734 0
Adelaide, South Australia
Ethics committee country [1] 2734 0
Australia
Date submitted for ethics approval [1] 2734 0
Approval date [1] 2734 0
Ethics approval number [1] 2734 0
05/31

Summary
Brief summary
Obesity is a major health problem, which contributes to significant morbidity and mortality in Australia. Energy restriction and exercise are commonly advocated as lifestyle approaches for the modification of cardiovascular disease risk factors such as obesity, hyperlipidemia, impaired glucose tolerance, and insulin resistance. In response to the increasing concerns about the rising level of obesity, there has been a multitude of “fad” diets developed outside the medical and nutritional recommendations for healthy eating and with this an increased popularity of diets very low in carbohydrates. However, due to the scant scientific evidence available for the long-term efficacy and safety of these diets, and their impact on risk factors for cardiovascular disease, cancer, renal function, bone health, psychosocial function and the capacity to undertake concurrent physical activity, there is a lack of evidenced-based public health recommendations and policy regarding these dietary patterns. This study will provide scientific evidence to validate optimum dietary recommendations for weight loss that can be used by health professionals who have a strong need for a rational basis for their advice to counsel obese patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36110 0
Address 36110 0
Country 36110 0
Phone 36110 0
Fax 36110 0
Email 36110 0
Contact person for public queries
Name 10206 0
Dr Grant Brinkworth
Address 10206 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10206 0
Australia
Phone 10206 0
+61 8 83038830
Fax 10206 0
+61 8 8303 8899
Email 10206 0
grant.brinkworth@csiro.au
Contact person for scientific queries
Name 1134 0
Dr Grant Brinkworth
Address 1134 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1134 0
Australia
Phone 1134 0
+61 8 83038830
Fax 1134 0
+61 8 8303 8899
Email 1134 0
grant.brinkworth@csiro.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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