Vascular effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA): the MARINA study
| ISRCTN | ISRCTN66664610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66664610 |
| Secondary identifying numbers | N2041 |
- Submission date
- 25/09/2008
- Registration date
- 17/12/2008
- Last edited
- 15/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thomas Sanders
Scientific
Scientific
Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk |
Study information
| Study design | Parallel design, double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at http://www.medscinet.net/marina/patientinfo.aspx |
| Scientific title | Influence of increasing intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on vascular function and risk factors for cardiovascular disease |
| Study acronym | MARINA |
| Study objectives | 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. |
| Ethics approval(s) | St. Thomas' Hospital Research Ethics Committee, 25/02/2008, ref: 08/H0802/3 |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), polyunsaturated fatty acids |
| Primary outcome measure | A change in endothelial function measured by the flow-mediated dilatation technique and ambulatory blood pressure, measured at baseline and 12 months. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| Key inclusion criteria | Men and women, aged 45 - 70 years |
| Key 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) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nutritional Science Division
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Franklin-Wilkins Building
150 Stamford Street
LONDON
SE1 9NH
England
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N2041)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2011 | Yes | No | |
| Results article | genetic analysis results | 01/07/2013 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
