Trial Review

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
ACTRN12609000195257
Ethics application status
Approved
Date submitted
9/02/2009
Date registered
20/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptability of fish oil to older adults
Scientific title
Acceptability of fish oil to older adults: how much is too much?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults with any medical condition 4271 0
Condition category
Condition code
Alternative and Complementary Medicine 4871 4871 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will be asked to taste three different concentrations of oral fish oil (100%, 40% and 10%), diluted with light olive oil, such that the total dosage of eicosapentanoic acid (EPA) will not exceed 5g. The oral fish oil will be presented on fruit juice, and rinsed down by a further dose of fruit juice. The tastings will take place on the same day with approximately 2-3 minutes between samples.
Intervention code [1] 3997 0
Other interventions
Comparator / control treatment
There is no comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5380 0
Taste, assessed using a 5 point visual analogue scale
Timepoint [1] 5380 0
At time of tasting
Secondary outcome [1] 9045 0
Side effects - the day following the tasting, study participants will be contacted and asked to report any perceived side effects. Possible side effects, such as fishy after taste and loose bowels, described at time of consent and given to participants in writing on the information sheet.
Timepoint [1] 9045 0
At 24 hours post-tasting
Secondary outcome [2] 9049 0
After taste, assessed using a 5 point visual analogue scale
Timepoint [2] 9049 0
At approximately 1 minute post-tasting

Eligibility
Key inclusion criteria
Participants will be selected from inpatients in the rehabilitation wards and acute medical wards at the Repatriation General Hospital, and patients in the outpatient department of the same hospital. Patients with any condition will be considered and assessed for eligibility against the exclusion criteria
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 60 years;
Allergy to fish;
Unable to consume thin fluids;
Have severe gastrointestinal disturbances;
Have recently suffered haemorrhagic stroke;
Have conditions which preclude the administration of fish oil;
Do not reside in the community at time of hospital admission or outpatients appointment;
Unable or unwilling to provide written informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4455 0
University
Name [1] 4455 0
Flinders University
Country [1] 4455 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Department of Rehabilitation and Aged Care, Flinders University, GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 4014 0
Individual
Name [1] 4014 0
Dr Michelle Miller
Address [1] 4014 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country [1] 4014 0
Australia
Other collaborator category [1] 557 0
Individual
Name [1] 557 0
Professor Robert Fraser
Address [1] 557 0
Division of Medicine, Repatriation General Hospital, Daw Park SA 5041
Country [1] 557 0
Australia
Other collaborator category [2] 558 0
Individual
Name [2] 558 0
Ms Alison Yaxley
Address [2] 558 0
Department of Rehabilitation and Aged Care, Flinders University, GPO Box 2100, Adelaide SA 5001
Country [2] 558 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6511 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 6511 0
Ethics committee country [1] 6511 0
Australia
Date submitted for ethics approval [1] 6511 0
Approval date [1] 6511 0
Ethics approval number [1] 6511 0
RGH 70/08

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

Contacts
Principal investigator
Name 29251 0
Address 29251 0
Country 29251 0
Phone 29251 0
Fax 29251 0
Email 29251 0
Contact person for public queries
Name 12498 0
Dr Michelle Miller
Address 12498 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 12498 0
Australia
Phone 12498 0
+61 8 8204 5328
Fax 12498 0
+61 8 8204 6406
Email 12498 0
[email protected]
Contact person for scientific queries
Name 3426 0
Dr Michelle Miller
Address 3426 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 3426 0
Australia
Phone 3426 0
+61 8 8204 5328
Fax 3426 0
+61 8 8204 6406
Email 3426 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.