Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000928415
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
12/07/2016
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish Oil Cell Uptake Study of Inflammation – a trial of fish oil supplementation in healthy volunteers
Scientific title
Fish Oil Cell Uptake Study of Inflammation – a trial of fish oil supplementation in healthy volunteers
Secondary ID [1] 289584 0
None
Universal Trial Number (UTN)
Trial acronym
FOCUS IN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular and adipose inflammation in atherosclerosis 299339 0
Condition category
Condition code
Cardiovascular 299323 299323 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 299325 299325 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy human volunteers will be randomised to one of four groups:
Group 1: Fish oil capsules high in EPA.
Group 2: Fish oil capsules high in DHA.
Group 3: Standard fish oil capsules, with 3:2 ratio of EPA to DHA.
Group 4: Placebo capsules.
Participants will be randomised in a 1:1:1:1 ratio. Participants will have blood taken before supplementation, and again after 30 days of supplementation.

Group 1: 8 capsules per day for 30 days. Each capsules contains 500mg of EPA and negligible DHA. Adherence monitored by counting of returned capsules.

Group 2: 6 capsules per day for 30 days. Each capsules contains 30mg of EPA and 707.5mg of DHA. Adherence monitored by counting of returned capsules.

Group 3: 7 capsules per day for 30 days. Each capsules contains 400mg of EPA and 200mg of DHA. Adherence monitored by counting of returned capsules.

Group 4: 7 capsules per day for 30 days. Each capsules contains 10mg of EPA and 6mg DHA. Adherence monitored by counting of returned capsules.
Intervention code [1] 295187 0
Prevention
Comparator / control treatment
Healthy human volunteers will take placebo capsules

Placebo capsule ingredients are: palm oil, gelatin (bovine), glycerol, sunflower oil, rapeseed oil, fish oil, mixed tocopherols.
Control group
Placebo

Outcomes
Primary outcome [1] 298803 0
Primary outcome: The impact of fish oil on the expression of inflammatory mediators produced by stimulated human umbilical vein endothelial cells (i.e. VCAM-1, ICAM-1, MCP-1) and mouse 3T3L1 adipocytes (i.e. IL-1beta, IL6, IL18, TNF-alpha, adiponectin, leptin and resistin).
Timepoint [1] 298803 0
Assessed at Day 1 and Day 30 by adding human serum to cells in culture
Secondary outcome [1] 325251 0
None
Timepoint [1] 325251 0
None

Eligibility
Key inclusion criteria
Healthy adult male and female human volunteers with no significant past medical history.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current cardiovascular medications.
Regular use of anti-inflammatory medications or blood-thinning medications. Current regular fish oil consumption or regular consumption within the last 6 months.
Regular consumption of 2 or more fish meals per week over the last 6 months. Pregnant and breastfeeding women are excluded.
Language barrier.
Seafood allergy and intolerance to fish oil capsules.
Anticipated medical indication for interruption of fish oil consumption during study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done via numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the random order for the allocation of subjects into different groups will be done by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample size is 40 participants. This is based on the paper published in NEJM titled “The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells”. In this study, volunteers had fish oil added to their usual Western diet for 6 weeks. Blood was taken before and after supplementation, and the production of interleukin 1-beta and tumor necrosis factor (proinflammatory cytokines) by mononuclear cells was measured. Mononuclear cells from whole blood were isolated using the Ficoll technique. These inflammatory cytokines significantly reduced after fish oil, with 9 participants in the study. In the current study, we propose a sample size of 10 per group to demonstrate a significant change in inflammatory markers, allowing for participant non-compliance or dropout.
Comparison of multiple vascular and adipose inflammatory markers between treatment groups will be made using a Kruskal-Wallis test and Dunn’s test for multiple comparisons.

The sample size was based on the paper mentioned above, and no additional power calculation was performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
3/10/2016
Actual
1/09/2016
Date of last data collection
Anticipated
31/10/2016
Actual
12/10/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6065 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment postcode(s) [1] 13514 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293973 0
Self funded/Unfunded
Name [1] 293973 0
Dr Anthony Pisaniello
Country [1] 293973 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony Pisaniello
Address
Level 6, South
Heart Health Theme
SAHMRI
North Terrace
Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 292787 0
None
Name [1] 292787 0
Address [1] 292787 0
Country [1] 292787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295388 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 295388 0
THE UNIVERSITY OF ADELAIDE Research Branch
Level 4 Rundle Mall Plaza
50 Rundle Mall
SA 5005
Ethics committee country [1] 295388 0
Australia
Date submitted for ethics approval [1] 295388 0
09/06/2015
Approval date [1] 295388 0
21/07/2015
Ethics approval number [1] 295388 0
H-2015-123

Summary
Brief summary
The FOCUS IN study is a clinical trial evaluating the impact of omega-3 fatty acids, found in fish oil, on inflammatory factors that contribute to heart disease. Coronary heart disease is due to a process called atherosclerosis, which the build-up of fatty tissue and plaque in arteries. Inflammation has been shown to be an important causal factor in atherosclerosis, and omega-3 fatty acids have been shown to have anti-inflammatory properties in previous studies. Study participants will be randomised to supplementation with various types of fish oil or a placebo for 30 days, and serum will be taken before and after supplementation. Serum will be added to cells in culture, derived from blood vessels and fat cells, and the impact of the serum on inflammatory factors that contribute to heart disease will be measured. This method of adding omega-3s to cells is a more biologically plausible method of studying the impact of omega-3 consumption on cellular function than adding pure omega-3s directly. The results of this study will guide further human studies of omega-3 supplementation on the development of heart disease.
Trial website
www.focusinstudy.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67078 0
Dr Anthony Pisaniello
Address 67078 0
Level 6, South
Heart Health Theme
SAHMRI
North Terrace
Adelaide, SA, 5000
Country 67078 0
Australia
Phone 67078 0
+61881284529
Fax 67078 0
Email 67078 0
[email protected]
Contact person for public queries
Name 67079 0
Dr Anthony Pisaniello
Address 67079 0
Level 6, South
Heart Health Theme
SAHMRI
North Terrace
Adelaide, SA, 5000
Country 67079 0
Australia
Phone 67079 0
+61881284529
Fax 67079 0
Email 67079 0
[email protected]
Contact person for scientific queries
Name 67080 0
Dr Anthony Pisaniello
Address 67080 0
Level 6, South
Heart Health Theme
SAHMRI
North Terrace
Adelaide, SA, 5000
Country 67080 0
Australia
Phone 67080 0
+61881284529
Fax 67080 0
Email 67080 0
[email protected]

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No Supporting Document Provided



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