Trial Review

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Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



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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
ACTRN12614000840684
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
7/08/2014
Date last updated
7/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dietary pork intake on serum irisin levels in people with type 2 diabetes
Scientific title
Four-week dietary pork intervention in adults with type 2 diabetes and its effect on serum irisin concentration.
Secondary ID [1] 285065 0
None
Universal Trial Number (UTN)
U1111-1159-7807
Trial acronym
PIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum irisin levels in adults with type 2 diabetics. 292592 0
Condition category
Condition code
Metabolic and Endocrine 292897 292897 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 4-week dietary intervention will be undertaken. Participants will be required to incorporate fresh pork meat into their habitual diet. Females will consume 150g of pork meat five days per week and males will consume 150g of pork meat seven days per week. Participants will be given a 2 week supply of frozen pork meat in a freezer bag at visits 1 and 2 to the University of Newcastle. Compliance will be monitored by the participants completing a pork consumption log. A list of pork recipes will be made available to participants. Consultation with a dietitian is not a part of the study protocol as the intervention, pork meat, is a commonly available product. However, one of the study investigators has a degree in nutrition & dietetics and if requested can give information to the participant.
Intervention code [1] 289904 0
Treatment: Other
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292770 0
Serum irisin concentration by competitive ELISA analysis
Timepoint [1] 292770 0
Baseline and at 4 weeks post-intervention
Secondary outcome [1] 309636 0
Fasting blood glucose levels by measured by Hunter Area Pathology Services.
Timepoint [1] 309636 0
Baseline and at 4-weeks post-intervention
Secondary outcome [2] 309637 0
Fasting insulin levels by measured by Hunter Area Pathology Services.
Timepoint [2] 309637 0
Baseline and at 4-weeks post-intervention
Secondary outcome [3] 309638 0
Blood lipid profile (total cholesterol, triglycerides, HDL and LDL cholesterol) measured by Hunter Area Pathology Services.
Timepoint [3] 309638 0
Baseline and at 4-weeks post-intervention
Secondary outcome [4] 309639 0
HOMA index measured by Hunter Area Pathology Services.
Timepoint [4] 309639 0
Baseline and at 4-weeks post-intervention
Secondary outcome [5] 309640 0
Body composition measured by InBody Body Composition Analyser
Timepoint [5] 309640 0
Baseline and at 4-weeks post-intervention

Eligibility
Key inclusion criteria
Aged 18 to 60 years, clinically diagnosed with type 2 diabetes, regular consumers of meat other than pork in their habitual diet, consuming no more than one pork meal per week and unlikely to change medication/supplement use during the 4-week dietary intervention period.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gestational diabetes, insulin dependent, active hepatitis/liver cirrhosis, chronic renal faliure on hemodialysis, congestive heart failure, any other major illnesses or diseases, smokers or currently on nicotine therapy, pregnant or breast feeding women, unwilling or unable to provide a fasting blood sample, unwilling or unable to maintain pre-enrollment habitual dietary and physical activity habits for the duration of the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are enrolled in the study after passing the inclusion/exclusion criteria, completing a health & lifestyle questionnaire and giving signed consent to participate in the study. Allocation is not concealed in the study.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study aims to detect a significant increase in serum irisin levels of at least 10% (approximately 3.0 pg/ml). Assuming a SD of difference = 3.5 pg/ml, 24 participants will provide 80% power to demonstrate a difference at alpha = 0.05. Allowing for an additional 25% for participant dropout and non-parametric analysis, we will recruit a total of 30 participants.
The effects of outcome measures will be analysed by paired t-test with a factor of time (baseline and post-intervention) to test for significant differences.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289671 0
Government body
Name [1] 289671 0
Pork CRC Ltd.
Country [1] 289671 0
Australia
Primary sponsor type
Individual
Name
Dr. Brendan Plunkett
Address
Nutraceuticals Research Group
University of Newcastle
MS 305
Medical Sciences Building
Callaghan
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 288363 0
None
Name [1] 288363 0
Address [1] 288363 0
Country [1] 288363 0
Other collaborator category [1] 278066 0
Individual
Name [1] 278066 0
Professor Manohar Garg
Address [1] 278066 0
Nutraceuticals Research Group University of Newcastle MS 305C Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country [1] 278066 0
Australia
Other collaborator category [2] 278067 0
Individual
Name [2] 278067 0
Professor Peter Howe
Address [2] 278067 0
Clinical Research Centre University of Newcastle MS 304 Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country [2] 278067 0
Australia
Other collaborator category [3] 278068 0
Individual
Name [3] 278068 0
Dr. Rachel Wong
Address [3] 278068 0
Clinical Research Centre University of Newcastle MS 514 Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country [3] 278068 0
Australia
Other collaborator category [4] 278069 0
Individual
Name [4] 278069 0
Ms Melilssa Fry
Address [4] 278069 0
Nutraceuticals Research Group University of Newcastle MS 305 Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country [4] 278069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291408 0
University of Newcastle HREC
Ethics committee address [1] 291408 0
Ethics committee country [1] 291408 0
Australia
Date submitted for ethics approval [1] 291408 0
05/05/2014
Approval date [1] 291408 0
01/07/2014
Ethics approval number [1] 291408 0
H-2014-0156

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

Contacts
Principal investigator
Name 50254 0
Prof Manohar Garg
Address 50254 0
Nutraceuticals Research Group University of Newcastle MS 305C Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country 50254 0
Australia
Phone 50254 0
+61 2 49215647
Fax 50254 0
Email 50254 0
[email protected]
Contact person for public queries
Name 50255 0
Brendan Plunkett
Address 50255 0
Nutraceuticals Research Group University of Newcastle MS 305 Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country 50255 0
Australia
Phone 50255 0
+61 2 49215636
Fax 50255 0
Email 50255 0
[email protected]
Contact person for scientific queries
Name 50256 0
Manohar Garg
Address 50256 0
Nutraceuticals Research Group University of Newcastle MS 305C Medical Sciences Callaghan University Drive Callaghan NSW 2308
Country 50256 0
Australia
Phone 50256 0
+61 2 49215647
Fax 50256 0
Email 50256 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.