Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000163404
Ethics application status
Approved
Date submitted
8/03/2007
Date registered
9/03/2007
Date last updated
9/03/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Protein intake metabolic effects study
Scientific title
A randomised controlled study to evaluate the effects of whey protein supplementation on bone structure, muscle mass, renal function, cardiovascular risk factors and body composition in elderly women
Universal Trial Number (UTN)
Trial acronym
PIMES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone structure of elderly healthy women 1665 0
Muscle mass of elderly healthy women 1666 0
Renal function of elderly healthy women 1667 0
Cardiovascular risk factors of elderly healthy women 1668 0
Body composition of elderly healthy women 1669 0
Condition category
Condition code
Musculoskeletal 1771 1771 0 0
Normal musculoskeletal and cartilage development and function
Cardiovascular 1772 1772 0 0
Normal development and function of the cardiovascular system
Renal and Urogenital 1773 1773 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-year randomised double-blind dietary intervention study of daily 30 g whey protein in the form of milk beverage drink versus placebo drink. All participants receive 600 mg calcium per day from the drink.
Intervention code [1] 1642 0
Prevention
Comparator / control treatment
Placebo drink
Control group
Placebo

Outcomes
Primary outcome [1] 2477 0
1) Bone structure of total body, hip, spine, forearm and tibia as measured by Dual Energy X-ray Absorptiometry and Quantitative Computed Tomography (QCT).
Timepoint [1] 2477 0
Measurements will be made at baseline, 1 and 2 years, except QCT of hip and spine, which will only be made at baseline and 2 years.
Primary outcome [2] 2478 0
2) Body composition using anthropometry (height, weight, waist circumference, waist and hip ratio, skin fold), Dual Energy X-ray Absorptiometry body composition and CT abdominal fat.
Timepoint [2] 2478 0
Measurements will be made at baseline, 1 and 2 years, except QCT of hip and spine, which will only be made at baseline and 2 years.
Secondary outcome [1] 4250 0
1) Hand grip strength and lower limb muscle strength as assessed by hand dynamometer and strain gauge.
Timepoint [1] 4250 0
Measurements will be made at baseline, 1 and 2 years.
Secondary outcome [2] 4251 0
2) Mobility function as assessed by the Timed Up and Go test.
Timepoint [2] 4251 0
Measurements will be made at baseline, 1 and 2 years.
Secondary outcome [3] 4252 0
3) Insulin like growth factor I (IGF-I).
Timepoint [3] 4252 0
Measurements will be made at baseline, 1 and 2 years.
Secondary outcome [4] 4253 0
4) Biochemical markers of bone turnover.
Timepoint [4] 4253 0
Measurements will be made at baseline, 1 and 2 years.
Secondary outcome [5] 4254 0
5) Renal function as assessed by glomerular filtration rate
Timepoint [5] 4254 0
Measurements will be made at baseline, 1 and 2 years.
Secondary outcome [6] 4255 0
6) Risk factors of cardiovascular diseases (blood pressure, blood profiles of lipids and glucose, serum c-reactive protein, apolipoprotein E and homocystine).
Timepoint [6] 4255 0
Measurements will be made at baseline, 1 and 2 years.

Eligibility
Key inclusion criteria
Able to comply with the requirements of the protocol.
Minimum age
70 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participation in another clinical trial during the last 12 weeks • Previous osteoporotic fracture• Currently or within last year taking medication for osteoporosis apart from calcium or vitamin D • Taking steroid tablets (eg Cortisone) in the past 3 months or have taken more than 7 g in total• Metabolic bone disease apart from osteoporosis• Total hip bone density more than 2SD below the mean for their age• Lactose intolerance or do not like milk products• High protein intake (more than 1.5 g/kg body weight per day)• Cognitive impairment (Mini Mental Sate score < 24)• Body mass index > 35 kg/cm2• Bowel surgery or difficulty absorbing food • Coeliac disease• Hepatic insufficiency or renal insufficiency • Participants who, in the opinion of the investigator are not likely to complete the study for any reason.

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)
Subject numbers will be allocated by personnel having no contact with study participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study participants, therapists, assessors and data analysts will remain blinded to the treatment code until all the data be entered, evaluated for accuracy and the a-priori hypotheses reviewed
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1923 0
Government body
Name [1] 1923 0
Australian National Health and Medical Research Council
Country [1] 1923 0
Australia
Primary sponsor type
Individual
Name
A Professor RL Prince
Address
Country
Secondary sponsor category [1] 1734 0
University
Name [1] 1734 0
The University of Western Australia and
Address [1] 1734 0
Country [1] 1734 0
Australia
Secondary sponsor category [2] 1735 0
Hospital
Name [2] 1735 0
the Sir Charles Gairdner Hospital
Address [2] 1735 0
Country [2] 1735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3577 0
The Sir Charles Gairdner Hospital
Ethics committee address [1] 3577 0
Ethics committee country [1] 3577 0
Australia
Date submitted for ethics approval [1] 3577 0
Approval date [1] 3577 0
21/02/2007
Ethics approval number [1] 3577 0
2006-181

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

Contacts
Principal investigator
Name 27576 0
Address 27576 0
Country 27576 0
Phone 27576 0
Fax 27576 0
Email 27576 0
Contact person for public queries
Name 10831 0
A Professor Richard Prince
Address 10831 0
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands 6009
Country 10831 0
Australia
Phone 10831 0
61 8 9346 4111
Fax 10831 0
61 8 9346 2733
Email 10831 0
[email protected]
Contact person for scientific queries
Name 1759 0
A Professor Richard Prince
Address 1759 0
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
Country 1759 0
Australia
Phone 1759 0
61 8 9346 4111
Fax 1759 0
61 8 9346 2733
Email 1759 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.