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.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
Scientific title
Phytosterols and omega-3 fatty acids for alleviation of plasma lipids in participants with Hyperlipidaemia
Query!
Secondary ID [1]
287927
0
nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
POFA Trial
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia
1427
0
Query!
Condition category
Condition code
Blood
1523
1523
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
1356
0
Lifestyle
Query!
Comparator / control treatment
4g sunola oil capsules or 25g plant sterol spread + 4g sunola oil capsules for 3 weeks for the control.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
2105
0
Query!
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.
Query!
Secondary outcome [1]
3647
0
The secondary outcomes are to evaluate changes in weight, blood pressure and markers of inflammation.
Query!
Assessment method [1]
3647
0
Query!
Timepoint [1]
3647
0
All these outcomes are measured at baseline and again at the completion of the study (3 weeks).
Query!
Eligibility
Key inclusion criteria
Participants with hyperlipidemia, and are not taking any lipid-lowering medications.
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Subjects already taking fish oil supplements and/or regularly consuming phytosterol enriched fat spreads.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Query!
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
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
30/10/2006
Query!
Actual
14/02/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
28/11/2008
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
1661
0
Other
Query!
Name [1]
1661
0
Pilot Research Grant
Query!
Address [1]
1661
0
University of Newcastle
University Drive
Callaghan, NSW 2308
Query!
Country [1]
1661
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Newcastle
Query!
Address
University of Newcastle
University Drive
Callaghan, NSW 2308
Query!
Country
Australia
Query!
Secondary sponsor category [1]
1466
0
None
Query!
Name [1]
1466
0
N/A
Query!
Address [1]
1466
0
Query!
Country [1]
1466
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
293870
0
University of Newcastle Human Research Ethics Committee
Query!
Ethics committee address [1]
293870
0
Chancellery Building University Drive University of Newcastle Callaghan, NSW 2308
Query!
Ethics committee country [1]
293870
0
Australia
Query!
Date submitted for ethics approval [1]
293870
0
05/10/2006
Query!
Approval date [1]
293870
0
30/11/2006
Query!
Ethics approval number [1]
293870
0
H-291-090
Query!
Summary
Brief summary
No change required, the details have already been provided.
Query!
Trial website
Query!
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.
Query!
Public notes
Query!
Attachments [1]
638
638
0
0
/AnzctrAttachments/81597-Micallef & Garg.JN 2008.pdf
Query!
Query!
Attachments [2]
639
639
0
0
/AnzctrAttachments/81597-Micallef & Garg.Atherosclerosis 2009.pdf
Query!
Query!
Contacts
Principal investigator
Name
27963
0
Prof Manohar Garg
Query!
Address
27963
0
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308
Query!
Country
27963
0
Australia
Query!
Phone
27963
0
+61-2-4921 5647
Query!
Fax
27963
0
Query!
Email
27963
0
[email protected]
Query!
Contact person for public queries
Name
10545
0
Professor Manohar Garg
Query!
Address
10545
0
School of Biomedical Sciences
Nutraceuticals Research Group
The University of Newcastle
Medical Sciences Building 305c
Callaghan Campus
NSW 2308
Query!
Country
10545
0
Australia
Query!
Phone
10545
0
(02)4921 5647
Query!
Fax
10545
0
(02)4921 2028
Query!
Email
10545
0
[email protected]
Query!
Contact person for scientific queries
Name
1473
0
Ms Michelle Micallef
Query!
Address
1473
0
School of Biomedical Sciences
Nutraceuticals Research Group
The University of Newcastle
Medical Sciences Building 305a
Callaghan Campus
NSW, 2308
Query!
Country
1473
0
Australia
Query!
Phone
1473
0
(02) 4921 5638
Query!
Fax
1473
0
Query!
Email
1473
0
[email protected]
Query!
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.
Download to PDF