Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000229370
Ethics application status
Approved
Date submitted
1/05/2008
Date registered
2/05/2008
Date last updated
2/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
2008 Weight Loss, Protein and Bone Density study
Scientific title
A randomised study to investigate the effect of high and normal protein content in weight loss diets on bone density in overweight post menopausal women.
Secondary ID [1] 550 0
KV56C issued by the Commonwealth Scientific Industrial Research Organisation (CSIRO)
Universal Trial Number (UTN)
Trial acronym
BD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 3101 0
Condition category
Condition code
Diet and Nutrition 3260 3260 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 104 week weight loss study of either:
A high protein diet (35% of calories as protein), low saturated fat (<10%), low total fat (<30%), OR
A normal protein diet with a protein level of 15-20% of calories, low saturated fat (<10%), low total fat (<30%). Both diets will contain 5000-6000KJ
Intervention code [1] 2843 0
Lifestyle
Comparator / control treatment
Normal protein (15-20% of energy) energy restricted diet.
Control group
Active

Outcomes
Primary outcome [1] 4151 0
weight, DEXA (dual energy x-ray absoptiometry), blood tests including vitamin D
Timepoint [1] 4151 0
baseline, 3 months, 6 months, 12 months and 24 months
Secondary outcome [1] 6995 0
24hour urinary urea, creatinine, calcium, sodium, phosphate.
Fasting urine pH, calcium, creatinine, sodium, phosphate.
Timepoint [1] 6995 0
baseline, 3 months, 6 months, 12 months and 24 months

Eligibility
Key inclusion criteria
• Female, post menopausal
• Aged between 40-70 years
• Body Mass Index (BMI) greater than 27, but a maximum weight of 140kg
• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Body mass index (BMI) less than 27
• Taking antiresorptive agents –including Hormone Replacement Therapy
• Vitamin D and/or parathyroid hormone (PTH) and/or serum calcium levels outside the normal range when tested at baseline. If vitamin D is less than 60 and PTH is normal participants will continue in the study but if PTH is also elevated then the participant will be withdrawn and referred to their GP for active treatment.
• Taking agents affecting calcium and bone metabolism such as calcium supplements, steroids or diuretics.
• Bone density in the osteoporotic density range (total hip 2 SD below normal) or a history of low trauma peripheral or spinal fracture (with density <1 SD below normal) as assessed at the baseline examination.
• Have a malignancy, or a history of metabolic disease such as liver, renal, unstable cardiovascular, respiratory or gastrointestinal disease.
• Have high uncontrolled hypertension (resting recumbent Blood Pressure >160/100 mmHg). Once controlled on medication the participant can enter the study
• History of heavy alcohol consumption (> 5 standard drinks/day)
• Unwilling to be randomized to either trial group
• Extended absences due to travel or other commitments
• Unable to comprehend or cope with study requirements
• At the commencement of the study bone density at the hip, spine and forearm will be measured. Those women in the osteoporotic density range (very low bone density ) at the first examination will not be eligible to participate but will be referred back to their general practitioner for specific treatment. Those with osteopenia (moderately low bone density) and no fractures will be able to continue in the study if they wish.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed when it was done by central randomisation by computer
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
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3348 0
Government body
Name [1] 3348 0
CSIRO Human Nutrition
Country [1] 3348 0
Australia
Primary sponsor type
Government body
Name
CSIRO Human Nutrition
Address
Gate 13
Kintore Avenue
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 2994 0
None
Name [1] 2994 0
Address [1] 2994 0
Country [1] 2994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5337 0
Ethics committee address [1] 5337 0
Ethics committee country [1] 5337 0
Date submitted for ethics approval [1] 5337 0
Approval date [1] 5337 0
Ethics approval number [1] 5337 0
06/23
Ethics committee name [2] 5373 0
CSIRO Human Research Ethics Committee
Ethics committee address [2] 5373 0
Ethics committee country [2] 5373 0
Australia
Date submitted for ethics approval [2] 5373 0
Approval date [2] 5373 0
19/02/2007
Ethics approval number [2] 5373 0

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

Contacts
Principal investigator
Name 28545 0
Address 28545 0
Country 28545 0
Phone 28545 0
Fax 28545 0
Email 28545 0
Contact person for public queries
Name 11702 0
Anne McGuffin
Address 11702 0
CSIRO Human Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 11702 0
Australia
Phone 11702 0
+61 83038988
Fax 11702 0
+61 83038899
Email 11702 0
[email protected]
Contact person for scientific queries
Name 2630 0
Dr Jennifer Keogh
Address 2630 0
CSIRO Human Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 2630 0
Australia
Phone 2630 0
+61 8303 8907
Fax 2630 0
+61 83038899
Email 2630 0
[email protected]

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.