Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000538347
Ethics application status
Approved
Date submitted
3/09/2008
Date registered
24/10/2008
Date last updated
16/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Health benefits of low fat dairy in overweight but healthy individuals
Scientific title
Dietary intervention trial of cardiometabolic health benefits of low fat dairy consumption in healthy but overweight adults.
Secondary ID [1] 280494 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 3631 0
Condition category
Condition code
Diet and Nutrition 3797 3797 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to consume a high dairy diet (>4 serves/day, low fat dairy <2% fat) for 12 months. A serve of dairy is based on Australian standardised serves, for example 1 serve of milk is 250mL or 1 cup. Foods will be provided for the volunteers for the duration of the trial. Compliance will be measured using weekly dairy consumption logs and weighed food records (at 0, 3, 6 and 12 months).
Intervention code [1] 3353 0
Prevention
Comparator / control treatment
Low dairy diet (<1serve/day). A serve of dairy is based on Australian standardised serves, for example 1 serve of milk is 250mL or 1 cup. Compliance will be measured using weighed food records at 0, 3, 6 and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 4702 0
Waist circumference
Timepoint [1] 4702 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [1] 7912 0
Waist/Hip ratio
Timepoint [1] 7912 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [2] 7930 0
% body fat (dual energy x-ray absorptiometry, DEXA)
Timepoint [2] 7930 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [3] 7931 0
Bone mineral density (DEXA)
Timepoint [3] 7931 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [4] 7932 0
Blood pressure and arterial compliance will be measured using a Hypertension Diagnostics Inc (HDI) /Pulsewave cardiovascular profilor.
Timepoint [4] 7932 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [5] 7933 0
Blood lipids (total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol.
Timepoint [5] 7933 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [6] 7934 0
Insulin sensitivity will be calculated using The Homeostasis Model Assessment (HOMA2) based on fasting plasma insulin and glucose measurements.
Timepoint [6] 7934 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [7] 7935 0
C-reactive protein will be measured using an automated spectrophotometric analyser with standard kits.
Timepoint [7] 7935 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [8] 7936 0
Resting metabolic rate (RMR) will be measured using indirect calorimetry using a Metabolic Monitor.
Timepoint [8] 7936 0
0 months, 3 months, 6 months, 12 months
Secondary outcome [9] 7937 0
Body Mass Index (BMI)
Timepoint [9] 7937 0
0 months, 3 months, 6 months, 12 months

Eligibility
Key inclusion criteria
BMI greater than or equal to 25 but otherwise healthy; able to consume dairy regularly for 12 months; non-smokers; aged 18-75; eat <2 serves of dairy per day
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Weight >135kg (DEXA limited); diagnosed diabetes or cardiovascular disease; taking fish oil (>1g/day); irregular use of medications that might interfere with outcomes of the study; females who are pregnant or possibly pregnant (DEXA); smokers.

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)
Subjects meeting entry criteria at screening will be allocated to a treatment at random by the study code-holder who will remain blinded to their identities. The code-holder will be contacted by electronic mail and provided with the age, gender and BMI of the individual to be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation of de-identified subjects based on age, gender and BMI. Stratified allocation of de-identified subjects based on age, gender and BMI will be done using permuted block randomisation.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
27/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1182 0
Canada
State/province [1] 1182 0
Winnipeg, Manitoba R3T 6C5, Canada

Funding & Sponsors
Funding source category [1] 3818 0
Government body
Name [1] 3818 0
Government of Manitoba
Country [1] 3818 0
Canada
Primary sponsor type
Individual
Name
Prof Peter Howe (Chief Investigator)
Address
GPO Box 2471, Adelaide 5001
Country
Australia
Secondary sponsor category [1] 3431 0
Individual
Name [1] 3431 0
Dr Curtis Rempel
Address [1] 3431 0
Richardson Centre for Functional Foods & Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, Manitoba R3T 6C5
Country [1] 3431 0
Canada
Other collaborator category [1] 399 0
Individual
Name [1] 399 0
A Pr Jon Buckley
Address [1] 399 0
GPO Box 2471, Adelaide 5001
Country [1] 399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5877 0
University of South Australia
Ethics committee address [1] 5877 0
Ethics committee country [1] 5877 0
Australia
Date submitted for ethics approval [1] 5877 0
Approval date [1] 5877 0
29/08/2008
Ethics approval number [1] 5877 0
P071/08

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

Contacts
Principal investigator
Name 28892 0
Address 28892 0
Country 28892 0
Phone 28892 0
Fax 28892 0
Email 28892 0
Contact person for public queries
Name 12049 0
Dr Karen Murphy
Address 12049 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide 5001
Country 12049 0
Australia
Phone 12049 0
08 8302 2097
Fax 12049 0
08 8302 2178
Email 12049 0
[email protected]
Contact person for scientific queries
Name 2977 0
Dr Karen Murphy
Address 2977 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide 5001
Country 2977 0
Australia
Phone 2977 0
08 8302 2097
Fax 2977 0
08 8302 2178
Email 2977 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Crichton et al. Nutrition & Metabolism 2012, 9:19 ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term dietary intervention trials: critical issues and challenges.2012https://dx.doi.org/10.1186/1745-6215-13-111
N.B. These documents automatically identified may not have been verified by the study sponsor.