Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000612011
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
28/07/2010
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative health benefits of lean fresh pork, chicken and beef in overweight but healthy individuals.
Scientific title
Assessing the effect of regular consumption of lean fresh pork, chicken and beef on body composition in healthy, but overweight participants.
Secondary ID [1] 252272 0
There is no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assessing the consumption of lean fresh pork, chicken and beef on body composition in healthy but overweight participants and its potential improvement on body composition (reducing body fat). 257776 0
Condition category
Condition code
Diet and Nutrition 257949 257949 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 3 months) then crossover to a, fresh lean chicken diet (participants will consume up to 7 serves of chicken per week for 3 months), then crossover to fresh lean beef diet (participants will consume up to 7 serves of chicken per week for 3 months). The diet order will be randomly allocated. There will be no washout period in-between diets.
Intervention code [1] 256843 0
Lifestyle
Comparator / control treatment
Comparative effects of eating pork, chicken and beef will be studied.
Control group
Active

Outcomes
Primary outcome [1] 258815 0
Percentage body fat using dual x-ray absorptiometry (DEXA)
Timepoint [1] 258815 0
0 months, 3 months, 6 months, 9 months.
Secondary outcome [1] 264896 0
Body weight (kg) will be measured using an electronic scale with subjects wearing minimal clothing and without shoes.
Timepoint [1] 264896 0
0 months, 3 months, 6 months, 9 months.
Secondary outcome [2] 264897 0
Waist circumference (cm) will be measured according to the International Standards for Anthropometric Assessment using a tape measure.
Timepoint [2] 264897 0
0 months, 3 months, 6 months, 9 months.
Secondary outcome [3] 264898 0
Hip circumference (cm) will be measured according to the International Standards for Anthropometric Assessment using a tape measure.
Timepoint [3] 264898 0
0 months, 3 months, 6 months, 9 months.
Secondary outcome [4] 264899 0
Waist/Hip ratio. Waist and hip circumference (cm) will be measured according to the International Standards for Anthropometric Assessment using a tape measure to calculate waist/hip ratio.
Timepoint [4] 264899 0
0 months, 3 months, 6 months, 9 months.

Eligibility
Key inclusion criteria
Body mass index (BMI) greater than or equal to 25 but otherwise healthy; omnivorous; able to eat pork for 3 months, chicken for 3 months, beef for 3 months; aged 18-65; not pregnant.
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, cardiovascular disease or liver or renal disease; females who are pregnant or possibly pregnant (DEXA); smokers; use of appetite suppressants or orlistat; actively undertaking a weight loss program; unable to consume pork, chicken or beef for 3 months.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2010
Actual
6/09/2010
Date of last participant enrolment
Anticipated
Actual
20/10/2010
Date of last data collection
Anticipated
Actual
29/06/2011
Sample size
Target
51
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 257306 0
Government body
Name [1] 257306 0
Pork Co-operative Research Centre (CRC)
Country [1] 257306 0
Australia
Primary sponsor type
Individual
Name
Prof Peter Howe (Chief Investigator)
Address
GPO Box 2471, Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 256552 0
Individual
Name [1] 256552 0
Dr Karen Murphy (Chief Investigator)
Address [1] 256552 0
GPO Box 2471, Adelaide South Australia 5001
Country [1] 256552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259333 0
University of South Australia
Ethics committee address [1] 259333 0
Ethics committee country [1] 259333 0
Australia
Date submitted for ethics approval [1] 259333 0
Approval date [1] 259333 0
30/06/2010
Ethics approval number [1] 259333 0
P092/10

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

Contacts
Principal investigator
Name 31412 0
Dr Karen Murphy
Address 31412 0
University of South Australia GPO Box 2471 Adelaide, SA 5001
Country 31412 0
Australia
Phone 31412 0
+61 8 8302 2097
Fax 31412 0
Email 31412 0
[email protected]
Contact person for public queries
Name 14659 0
Karen Murphy
Address 14659 0
GPO Box 2471, Adelaide SA 5001.
Country 14659 0
Australia
Phone 14659 0
+61 8 83022097
Fax 14659 0
+61 8 83022178
Email 14659 0
[email protected]
Contact person for scientific queries
Name 5587 0
Prof Peter Howe
Address 5587 0
GPO Box 2471, Adelaide SA 5001.
Country 5587 0
Australia
Phone 5587 0
+61 8 83022097
Fax 5587 0
+61 8 83022178
Email 5587 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.