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Trial registered on ANZCTR


Registration number
ACTRN12610000718044
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
30/08/2010
Date last updated
30/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is fish intake or fish oil supplementation better for people with coronary heart disease? An Australian secondary prevention trial.
Scientific title
In people with coronary heart disease, can consumption of fish and fish oil capsules, estimated to provide similar amounts of long-chain omega 3 fatty acids, achieve similar and significant increases in erythrocyte omega-3 index ?
Secondary ID [1] 252454 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 257966 0
Condition category
Condition code
Cardiovascular 258134 258134 0 0
Coronary heart disease
Alternative and Complementary Medicine 258185 258185 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects were instructed to consume either 2 serves of approximately 150 g of salmon per week, or 6 fish oil capsules per week; each of which was estimated to provide an average of approximately 1000mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day. In a randomised cross-over design each person consumed fish and fish oil for 12 weeks each, with 12 weeks washout between interventions.
Intervention code [1] 257022 0
Lifestyle
Intervention code [2] 257059 0
Prevention
Intervention code [3] 257060 0
Treatment: Other
Comparator / control treatment
Comparison was within person looking at changes on each intervention, fish or fish oil.
Control group
Active

Outcomes
Primary outcome [1] 258998 0
Erythrocyte omega 3 index, ie the proportion of DHA and EPA in the total fatty acids in red cell membranes.
Red blood cells were isolated and fatty acids assessed using gas-liquid chromatography.
Timepoint [1] 258998 0
Measured at baseline, after 12 weeks on the first intervention, 12 weeks later at end of washout and at 36 weeks after 12 weeks on the second intervention.
Secondary outcome [1] 265224 0
Blood pressure measured using an automated blood pressure monitor (Omron model T9P (HEM-759P-CI), Omron Healthcare Co. Ltd, Japan).
Timepoint [1] 265224 0
Measured at baseline, after 12 weeks on the first intervention, 12 weeks later at end of washout and at 36 weeks after 12 weeks on the second intervention.

Eligibility
Key inclusion criteria
Coronary heart disease, including but not limited to those with angina, a previous myocardial infarction (MI) and post-coronary artery bypass.
Minimum age
32 Years
Maximum age
62 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded on the basis of previous stroke; chronic illnesses such as kidney, liver disease and cancer; having an implantable cardioverter-defibrillator (ICD); religious, cultural or medical factors preventing compliance with either intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the subject was enrolled they were allocated alternatively to fish or fish oil.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3143 0
3071
Recruitment postcode(s) [2] 3144 0
3065
Recruitment postcode(s) [3] 3145 0
3104
Recruitment postcode(s) [4] 3146 0
3103
Recruitment postcode(s) [5] 3147 0
3198
Recruitment postcode(s) [6] 3148 0
3150

Funding & Sponsors
Funding source category [1] 257473 0
University
Name [1] 257473 0
University of Melbourne
Address [1] 257473 0
Melbourne Research
Level 5, Alan Gilbert Building
161 barry St
Carlton
Vic 3053
Country [1] 257473 0
Australia
Primary sponsor type
Individual
Name
Laima Brazionis
Address
Laima Brazionis PhD
Senior Research Fellow
Public Health and Epidemiology
Division of Health Sciences
Sansom Institute
Playford 4-25
University of South Australia
City East Campus
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 256700 0
Individual
Name [1] 256700 0
Allison Hodge
Address [1] 256700 0
Allison Hodge PhD
National Health and Medical Research Council (NHMRC) Post Doctoral Research Fellow
University of Melbourne
Department of Medicine
St Vincent's Hospital
PO Box 2900
Fitzroy, Victoria 3065
Country [1] 256700 0
Australia
Other collaborator category [1] 251446 0
Individual
Name [1] 251446 0
Catherine Itsiopoulos
Address [1] 251446 0
Associate Professor Catherine Itsiopoulos
Head of Nutrition and Dietetics
Faculty of Health
University of Canberra ACT 2601
Country [1] 251446 0
Australia
Other collaborator category [2] 251448 0
Individual
Name [2] 251448 0
Eugene Ik Chiek Ting
Address [2] 251448 0
Medicine, Dentistry and Health Sciences Student Centre
Level 1, Brownless Biomedical Library
The University of Melbourne
Victoria 3010 Australia
Country [2] 251448 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259519 0
St Vincents Hospital, Research Governance Unit, Human Research Ethics Committee
Ethics committee address [1] 259519 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy
Victoria 3065
Ethics committee country [1] 259519 0
Australia
Date submitted for ethics approval [1] 259519 0
Approval date [1] 259519 0
03/09/2008
Ethics approval number [1] 259519 0
HREC-A 090/08

Summary
Brief summary
We conducted a randomised cross-over dietary intervention trial to compare the effects of 1g EPA+DHA per day from two different sources – fish and fish oil capsules. Subjects were randomised to begin on one arm of the intervention for 12 weeks, followed by a 12-week washout period and finally the alternate arm for another 12 weeks. Various cardiovascular risk markers were measured at each time point. Statistical analyses were performed to compare changes with each intervention, and the changes between the two treatment arms.

11 participants (10 males and 1 female) with a mean age of 50.9 years were recruited from St. Vincent’s Hospital, Melbourne from September 2008 to May 2009.
Both treatments increased erythrocyte omega-3 index significantly, while the fish treatment also appeared to have beneficial effects on blood pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31527 0
Address 31527 0
Country 31527 0
Phone 31527 0
Fax 31527 0
Email 31527 0
Contact person for public queries
Name 14774 0
Laima Brazionis
Address 14774 0
Senior Research Fellow
Public Health and Epidemiology
Division of Health Sciences
Sansom Institute
Playford 4-25
University of South Australia
City East Campus
Adelaide, SA 5000
Country 14774 0
Australia
Phone 14774 0
+61 8 8302 2405
Fax 14774 0
+61 8 8302 2405
Email 14774 0
Laima.Brazionis@unisa.edu.au
Contact person for scientific queries
Name 5702 0
Laima Brazionis
Address 5702 0
Senior Research Fellow
Public Health and Epidemiology
Division of Health Sciences
Sansom Institute
Playford 4-25
University of South Australia
City East Campus
Adelaide, SA 5000
Country 5702 0
Australia
Phone 5702 0
+61 8 8302 2405
Fax 5702 0
+61 8 8302 2794
Email 5702 0
Laima.Brazionis@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary