Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000190303
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
11/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Health benefits of fresh pork in overweight but healthy individuals.
Scientific title
Assessing cardiometabolic health benefits (primarily body fat) associated with eating fresh pork in healthy, but overweight participants.
Secondary ID [1] 280493 0
New secondary ID. Please modify.
ACTRN12608000190303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy but overweight volunteers are being studied. The intervention may improve body composition (reducing body fat). 3016 0
Condition category
Condition code
Diet and Nutrition 3165 3165 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fresh lean pork diet (participants will consume up to 7 serves of pork per week for 6 months), habitual diet (participants who are low pork eaters (less than 1 serve a week) will maintain their regular diet for 6 months.
Intervention code [1] 2754 0
Other interventions
Intervention code [2] 2755 0
Lifestyle
Comparator / control treatment
Habitual diet (no intervention), 6 months duration
Control group
Active

Outcomes
Primary outcome [1] 4048 0
Percentage body fat using dual x-ray absorptiometry (DEXA)
Timepoint [1] 4048 0
0 months, 3 months, 6 months
Secondary outcome [1] 6811 0
Body weight
Timepoint [1] 6811 0
0 months, 3 months, 6 months

Eligibility
Key inclusion criteria
BMI greater than or equal to 25 but otherwise healthy; able to eat pork for 6 months; aged 18-65; eat less than 1 serve of pork per week.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Weight >136kg (DEXA limited); diagnosed diabetes or cardiovascular disease; taking fish oil (>1g/d); females who are pregnant or possibly pregnant (DEXA); smokers.

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)
Contacting the holder of the randomisation schedule who would not be seeing volunteers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on age, gender and BMI
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
21/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3270 0
Government body
Name [1] 3270 0
Pork CRC
Country [1] 3270 0
Australia
Primary sponsor type
Individual
Name
Prof Peter Howe (Chief Investigator)
Address
GPO Box 2471, Adelaide 5001
Country
Australia
Secondary sponsor category [1] 2924 0
Individual
Name [1] 2924 0
A Pr Jon Buckley
Address [1] 2924 0
GPO Box 2471, Adelaide 5001
Country [1] 2924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5256 0
University of South Australia
Ethics committee address [1] 5256 0
City East, North Terrace, South Australia 5000
Ethics committee country [1] 5256 0
Australia
Date submitted for ethics approval [1] 5256 0
Approval date [1] 5256 0
19/12/2007
Ethics approval number [1] 5256 0
P330/07

Summary
Brief summary
Studies have shown that high protein diets containing lean cuts of meat can improve a number of cardiovascular disease risk factors, including improved glucose control and insulin sensitivity, increased satiety, reductions in blood cholesterol, risk of type II diabetes, blood pressure and body weight and improved weight control. Lean pork as part of a high protein diet has not been studied.

The aims of our research is to evaluate the health benefits of regular pork consumption by determining the relationship between consumption of pork and markers of cardiovascular and metabolic (cardiometabolic) health which include body composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance, blood pressure and insulin sensitivity.

Hypothesis:
-Regular consumption of lean fresh pork will not increase risk factors for cardiovascular disease but may actually improve cardiometabolic health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28504 0
Address 28504 0
Country 28504 0
Phone 28504 0
Fax 28504 0
Email 28504 0
Contact person for public queries
Name 11661 0
Dr Karen Murphy
Address 11661 0
Nutritional Physiology Research Centre, University of South Australia GPO Box 2471 Adelaide 5001
Country 11661 0
Australia
Phone 11661 0
08 8302 2097
Fax 11661 0
08 8302 2178
Email 11661 0
[email protected]
Contact person for scientific queries
Name 2589 0
Dr Karen Murphy
Address 2589 0
Nutritional Physiology Research Centre, University of South Australia GPO Box 2471 Adelaide 5001
Country 2589 0
Australia
Phone 2589 0
08 8302 2097
Fax 2589 0
08 8302 2178
Email 2589 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.