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Vascular effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA): the MARINA study
ISRCTN ISRCTN66664610
DOI 10.1186/ISRCTN66664610
ClinicalTrials.gov identifier
EudraCT number
Public title Vascular effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA): the MARINA study
Scientific title Influence of increasing intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on vascular function and risk factors for cardiovascular disease
Acronym MARINA
Serial number at source N2041
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval St. Thomas' Hospital Research Ethics Committee, 25/02/2008, ref: 08/H0802/3
Study design Parallel design, double-blind placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular disease
Participants - inclusion criteria Men and women, aged 45 - 70 years
Participants - exclusion criteria 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)
Anticipated start date 01/06/2008
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material Patient information material can be found at http://www.medscinet.net/marina/patientinfo.aspx
Target number of participants 360
Interventions 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.
Primary outcome measure(s) A change in endothelial function measured by the flow-mediated dilatation technique and ambulatory blood pressure, measured at baseline and 12 months.
Secondary outcome measure(s) 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
Sources of funding Food Standards Agency (UK) (ref: N2041)
Trial website http://www.medscinet.net/marina/
Publications 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21865334
2013 genetic analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/23658423
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401815
Contact name Prof  Thomas  Sanders
  Address Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
  City/town London
  Zip/Postcode SE1 9NH
  Country United Kingdom
  Tel +44 (0)20 7848 4273
  Fax +44 (0)20 7848 4171
  Email tom.sanders@kcl.ac.uk
Sponsor King's College London (UK)
  Address Franklin-Wilkins Building
150 Stamford Street
  City/town LONDON
  Zip/Postcode SE1 9NH
  Country United Kingdom
  Tel +44 (0)20 7848 4273
  Fax +44 (0)20 7848 4171
  Email tom.sanders@kcl.ac.uk
  Sponsor website: http://www.kcl.ac.uk
Date applied 25/09/2008
Last edited 15/04/2014
Date ISRCTN assigned 17/12/2008
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