Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000468022
Ethics application status
Approved
Date submitted
24/04/2009
Date registered
9/06/2010
Date last updated
9/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of dairy intake and resistance exercise on weight loss in overweight or obese caucasian men and women
Scientific title
The impact of varying serves of dairy product and resistance exercise on weight loss and body fat distribution in obese caucasian Australians.
Secondary ID [1] 251954 0
nil
Universal Trial Number (UTN)
Trial acronym
ProHealth
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 4656 0
Condition category
Condition code
Diet and Nutrition 4960 4960 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to one of three groups for a duration of 12 weeks. Group 1: 3 serves of dairy product/day only [1 serve each of milk, cheese & fruit yoghurt], Group 2: 5 serves of dairy/day only[ 2 serves of milk, 1 of cheese, 2 of fruit yoghurt], Group 3: 5 serves/day plus resistance exercise training. All subjects will be prescribed an individualized energy restricted diet that will consist of normal foods eaten by the subject but tailored to meet National Health and Medical Research Council (NH&MRC) dietary guidelines. Dairy products like low-fat milk, cheese, and fruit yoghurt will be provided to all subjects in sufficient quantities to help them fulfill the requirement for their group allocation. The resistance training group will, in addition, undergo individualized, incremental exercise training under the supervision of qualified trainer. Each session will start with a 15 min warm up, followed by 45 - 90 min exercise and end with a 15 cool down. All exercise sessions will be conducted 3 times per week. At each session, subjects will complete one set of 10 exercises at 10 repetition maximum (10-RM), for the first two weeks, increasing to two sets by week 4, three sets by week 6, and four sets by week 8. The latter intensity will be maintained till the end of trail by week 12.
Intervention code [1] 4421 0
Other interventions
Intervention code [2] 256619 0
Lifestyle
Comparator / control treatment
Group 1: 3 serves of dairy/day as part of foods normally eaten and following standard National Health and Medical Research Council (NH&MRC) dietary guidelines.
Control group
Active

Outcomes
Primary outcome [1] 5808 0
Body fat loss and its distribution will be measured by dual energy x-ray absorptiometry (DEXA) scans of the whole body, and from anthropometry.
Timepoint [1] 5808 0
1 week before intervention, between week 12 and 13 after weight loss intervention, and at follow up between 24 and 25 weeks.
Secondary outcome [1] 241812 0
Blood samples will be collected at three time points. After separation into appropriate fractions and storage, the samples will be sent to an accredited laboratory for measurements of hormones and markers of disease like, glucose, insulin, vitamin D, parathyroid hormone, C-reactive protein, free fatty acids, glycerol etc.
Timepoint [1] 241812 0
1 week before intervention, between week 12 and 13 after weight loss intervention, and at follow up between 24 and 25 weeks.

Eligibility
Key inclusion criteria
Caucasian adults, body mass index >25 kg/m2, weight stable over last 6 months, sedentary to moderately active
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lactose intolerance, claustrophobia, active heart, liver or kidney disease, gastrointestinal disturbances, vitamin supplements

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 is not concealed
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4846 0
Other Collaborative groups
Name [1] 4846 0
The Australian Technology Network (ATN) Center for Metabolic fitness.
Country [1] 4846 0
Australia
Funding source category [2] 4847 0
Government body
Name [2] 4847 0
Diabetes Australia
Country [2] 4847 0
Australia
Primary sponsor type
Individual
Name
Dr Mario Soares
Address
School of Public Health,
GPO Box U 1987
Bentley Campus,
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4383 0
University
Name [1] 4383 0
Curtin University of Technology
Address [1] 4383 0
School of Public Health,
GPO Box U 1987
Bentley Campus,
Perth WA 6845
Country [1] 4383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6903 0
Human Research Ethics Committee
Ethics committee address [1] 6903 0
Curtin University
GPO Box U 1987
Bentley Campus,
Perth WA 6845
Ethics committee country [1] 6903 0
Australia
Date submitted for ethics approval [1] 6903 0
Approval date [1] 6903 0
Ethics approval number [1] 6903 0
HR 20/2005

Summary
Brief summary
There is evidence to support a beneficial effect of dairy products in weight loss programs. This trial hopes to document whether increasing the number of serves of dairy per day will increase the amount of body fat lost or change its distribution to a more healthy profile. We will also study if there are any benefits for cardiovascular disease and type 2 diabetes, by monitoring the changes in some key risk markers for these conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29528 0
Address 29528 0
Country 29528 0
Phone 29528 0
Fax 29528 0
Email 29528 0
Contact person for public queries
Name 12775 0
Dr. Mario Soares
Address 12775 0
School of Public Health,
GPO Box U 1987
Bentley Campus,
Perth WA 6845
Country 12775 0
Australia
Phone 12775 0
61-8-92663220
Fax 12775 0
61-8-92662958
Email 12775 0
[email protected]
Contact person for scientific queries
Name 3703 0
Dr Mario Soares
Address 3703 0
School of Public Health,
GPO Box U 1987
Bentley Campus,
Perth WA 6845
Country 3703 0
Australia
Phone 3703 0
61-8-92663220
Fax 3703 0
61-8-92662958
Email 3703 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.