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ISRCTN
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ISRCTN66664610
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ClinicalTrials.gov identifier
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Public title
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Vascular effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA): the MARINA study
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Scientific title
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Influence of increasing intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on vascular function and risk factors for cardiovascular disease
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Acronym
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MARINA
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Serial number at source
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N2041
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Study hypothesis
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Increasing the intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) will have favourable effects on heart-rate variability, endothelial function, arterial stiffness, blood pressure and these effects will be dose-related.
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Lay summary
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Not provided at time of registration
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Ethics approval
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St. Thomas' Hospital Research Ethics Committee approved the study on 25th February 2008 (ref: 08/H0802/3)
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Study design
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Parallel design, double-blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Men and women, aged 45 - 70 years
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Participants - exclusion criteria
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1. A reported history of angina, myocardial infarction or stroke
2. Clinical history of cancer (excluding basal cell carcinoma) in the past five years
3. Uncontrolled type 2 diabetes mellitus (fasting plasma glucose greater than 7 mmol/L)
4. Type 1 diabetes mellitus
5. Chronic renal, liver or inflammatory bowel disease
6. Current cigarette smoker
7. History of substance abuse or alcoholism (previous weekly alcohol intake greater than 60 units/men or 50 units/women)
8. Current self-reported weekly alcohol intake not exceeding 21 units for women and 28 for men
9. Currently pregnant, planning pregnancy or having had a baby in the last 12 months (there are no hazards from the EPA or DHA with regard to pregnancy outcome)
10. Allergy or intolerance to any component of study capsules
11. Unwilling to follow the protocol and/or give informed consent
12. Unwilling to refrain from use of dietary supplements including other sources of fish oil (e.g. cod liver oil)
13. Unwilling to restrict consumption of oily fish
14. Weight change of greater than 3 kg in preceding 2 months
15. Body mass index less than 20 and greater than 35 kg/m^2
16. Subjects with an overall risk of cardiovascular disease over the next ten years of greater than 20% who have untreated high blood pressure or raised cholesterol (subjects who are on stable medication for blood pressure or serum cholesterol [statins] will be included)
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Anticipated start date
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01/06/2008
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Patient information material can be found at http://www.medscinet.net/marina/patientinfo.aspx
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Target number of participants
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360
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Interventions
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This is a dietary intervention involving supplementation with encapsulated (n-3) polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), at three different doses (0.45, 0.9 and 1.8 g/d), compared with olive oil (BP specification) placebo. The duration of the intervention is 13 months. One month run-in on placebo and 12 months on one of four treatments.
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Primary outcome measure(s)
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A change in endothelial function measured by the flow-mediated dilatation technique and ambulatory blood pressure, measured at baseline and 12 months.
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Secondary outcome measure(s)
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1. Heart rate variability, measured at baseline, 6 months and 12 months
2. Arterial stiffness, measured at baseline and 12 months
3. Endothelial progenitor cell number, measured at baseline, 6 months and 12 months
4. Serum lipids, measured at baseline, 6 months and 12 months
5. C-reactive protein, measured at baseline, 6 months and 12 months
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Sources of funding
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Food Standards Agency (UK) (ref: N2041)
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Trial website
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http://www.medscinet.net/marina/
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21865334
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Contact name
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Prof
Thomas
Sanders
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Address
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Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4273
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Fax
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+44 (0)20 7848 4171
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Email
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tom.sanders@kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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Franklin-Wilkins Building
150 Stamford Street
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City/town
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LONDON
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4273
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Fax
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+44 (0)20 7848 4171
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Email
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tom.sanders@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk
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Date applied
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25/09/2008
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Last edited
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04/10/2011
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Date ISRCTN assigned
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17/12/2008
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