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
ACTRN12606000453583
Ethics application status
Approved
Date submitted
18/10/2006
Date registered
20/10/2006
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Lipid lowering potential of combined phytosterols and long chain omega-3 fatty acids
Scientific title
Phytosterols and omega-3 fatty acids for alleviation of plasma lipids in participants with Hyperlipidaemia
Secondary ID [1] 287927 0
nil known
Universal Trial Number (UTN)
Trial acronym
POFA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia 1427 0
Condition category
Condition code
Blood 1523 1523 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to recieve either 4g omega-3 fish oil capsules or 25g plant sterol spread + 4g fish oil capsules for 3 weeks for the treatment. Participants are assessed at baseline and again at the completion of the study (3 weeks)
Intervention code [1] 1356 0
Lifestyle
Comparator / control treatment
4g sunola oil capsules or 25g plant sterol spread + 4g sunola oil capsules for 3 weeks for the control.
Control group
Active

Outcomes
Primary outcome [1] 2105 0
The primary outcome of this trial is to evaluate the effect of phytosterols and omega-3 fatty acids on plasma cholesterol and triglyceride levels.
Timepoint [1] 2105 0
Blood samples will be taken at the commencement of the study and again at the completion of the study (3 weeks). A full blood lipid pannel including cholesterol, triglycerides, LDL and HDL will be generated from each sample. Baseline samples will be comparred with post intervention samples to determine the effect of phytosterols and omega-3 fatty acids on plasma cholesterol and triglycerides.
Secondary outcome [1] 3647 0
The secondary outcomes are to evaluate changes in weight, blood pressure and markers of inflammation.
Timepoint [1] 3647 0
All these outcomes are measured at baseline and again at the completion of the study (3 weeks).

Eligibility
Key inclusion criteria
Participants with hyperlipidemia, and are not taking any lipid-lowering medications.
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects already taking fish oil supplements and/or regularly consuming phytosterol enriched fat spreads.

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation via block randomisation using a randomisation table from a statistics book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2006
Actual
14/02/2007
Date of last participant enrolment
Anticipated
Actual
28/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1661 0
Other
Name [1] 1661 0
Pilot Research Grant
Country [1] 1661 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 1466 0
None
Name [1] 1466 0
N/A
Address [1] 1466 0
Country [1] 1466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293870 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 293870 0
Chancellery Building
University Drive
University of Newcastle
Callaghan, NSW 2308
Ethics committee country [1] 293870 0
Australia
Date submitted for ethics approval [1] 293870 0
05/10/2006
Approval date [1] 293870 0
30/11/2006
Ethics approval number [1] 293870 0
H-291-090

Summary
Brief summary
No change required, the details have already been provided.
Trial website
Trial related presentations / publications
M.A. Micallef and M.L. Garg (2008) The lipid-lowering effects of phytosterols and (n-3) polyunsaturated fatty acids are synergistic and complementary in hyperlipidemic men and women. Journal of Nutrition 138, 1086-1090.

M.A. Micallef and M.L. Garg (2009) Anti-inflammatory and cardio-protective effects of n-3 polyunsaturated fatty acids and plant sterols in hyperlipidemic individuals. Atherosclerosis 204, 476-482.

M.A. Micallef and M.L. Garg (2007) Synergistic lipid-lowering effects of phytosterols and long chain omega-3 fatty acids (LCn-3PUFA) in hyperlipidemic subjects. Australian Atherosclerosis Society Meeting, Fremantle, WA, Australia.

Micallef, M.A & Garg, M.L. (2008) “Anti-inflammatory and cardio-protective effects of omega-3 polyunsaturated fatty acids and plant sterols in hyperlipidemic individuals.” Asia Pacific Journal of Clinical Nutrition,17, p80.
Public notes
Attachments [1] 638 638 0 0
/AnzctrAttachments/81597-Micallef & Garg.JN 2008.pdf
Attachments [2] 639 639 0 0
/AnzctrAttachments/81597-Micallef & Garg.Atherosclerosis 2009.pdf

Contacts
Principal investigator
Name 27963 0
Prof Manohar Garg
Address 27963 0
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308
Country 27963 0
Australia
Phone 27963 0
+61-2-4921 5647
Fax 27963 0
Email 27963 0
[email protected]
Contact person for public queries
Name 10545 0
Prof Professor Manohar Garg
Address 10545 0
School of Biomedical Sciences
Nutraceuticals Research Group
The University of Newcastle
Medical Sciences Building 305c
Callaghan Campus
NSW 2308
Country 10545 0
Australia
Phone 10545 0
(02)4921 5647
Fax 10545 0
(02)4921 2028
Email 10545 0
[email protected]
Contact person for scientific queries
Name 1473 0
Dr Ms Michelle Micallef
Address 1473 0
School of Biomedical Sciences
Nutraceuticals Research Group
The University of Newcastle
Medical Sciences Building 305a
Callaghan Campus
NSW, 2308
Country 1473 0
Australia
Phone 1473 0
(02) 4921 5638
Fax 1473 0
Email 1473 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.