ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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).

Condition category

Condition code

Diet and Nutrition

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]

Lifestyle

Comparator / control treatment

Comparative effects of eating pork, chicken and beef will be studied.

Control group

Active

Outcomes

Primary outcome [1]

Percentage body fat using dual x-ray absorptiometry (DEXA)

Timepoint [1]

0 months, 3 months, 6 months, 9 months.

Secondary outcome [1]

Body weight (kg) will be measured using an electronic scale with subjects wearing minimal clothing and without shoes.

Timepoint [1]

0 months, 3 months, 6 months, 9 months.

Secondary outcome [2]

Waist circumference (cm) will be measured according to the International Standards for Anthropometric Assessment using a tape measure.

Timepoint [2]

0 months, 3 months, 6 months, 9 months.

Secondary outcome [3]

Hip circumference (cm) will be measured according to the International Standards for Anthropometric Assessment using a tape measure.

Timepoint [3]

0 months, 3 months, 6 months, 9 months.

Secondary outcome [4]

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]

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]

Government body

Name [1]

Pork Co-operative Research Centre (CRC)

Address [1]

Level 1 Eastick Building, University of Adelaide, Roseworthy Campus. PO Box 466, Willaston, South Australia 5118

Country [1]

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]

Individual

Name [1]

Dr Karen Murphy (Chief Investigator)

Address [1]

GPO Box 2471, Adelaide South Australia 5001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia

Ethics committee address [1]

Mawson Lakes Campus, Mawson Lakes Boulevard, Mawson Lakes, 5095, South Australia.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/06/2010

Ethics approval number [1]

P092/10

Summary

Brief summary

Studies have shown that high protein diets containing lean cuts of meat can improve body composition. Lean pork as part of a high protein diet has not been studied. 

Data from our previous trial demonstrated that regularly eating lean fresh pork was not detrimental to cardiovascular health and in fact improved indices of body composition.  These improvements were evident after only 3 months of eating pork (compared with habitual diets) and were achieved without restricting energy intake and while total protein intake (from all dietary sources) remained the same for both groups throughout the intervention.  These data indicate that the changes in body composition seen are unlikely to be solely a protein related effect however we are unable to say if the changes in body composition were specific to pork or to pork protein or whether consumption of other high protein meat diets may have had the same benefit.  

Therefore the aim of the current project is to conduct a 3 month dietary intervention trial to compare the effect on body composition of regular consumption of lean pork with that of two other commonly consumed meats in the Australian diet, namely chicken and beef.  

We aim to demonstrate that regular consumption of pork is no worse, and possibly better, than the main alternative meat options in terms of improving indices of body composition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Karen Murphy

Address

University of South Australia GPO Box 2471 Adelaide, SA 5001

Country

Australia

Phone

+61 8 8302 2097

Fax

Email

karen.murphy@unisa.edu.au

Contact person for public queries

Name

Karen Murphy

Address

GPO Box 2471, Adelaide SA 5001.

Country

Australia

Phone

+61 8 83022097

Fax

+61 8 83022178

Email

karen.murphy@unisa.edu.au

Contact person for scientific queries

Name

Prof Peter Howe

Address

GPO Box 2471, Adelaide SA 5001.

Country

Australia

Phone

+61 8 83022097

Fax

+61 8 83022178

Email

peter.howe@unisa.edu.au

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.