Condition category
Circulatory System
Date applied
25/09/2008
Date assigned
17/12/2008
Last edited
15/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medscinet.net/marina/

Contact information

Type

Scientific

Primary contact

Prof Thomas Sanders

ORCID ID

Contact details

Nutritional Science Division
4th Floor
Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N2041

Study information

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

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.

Ethics approval

St. Thomas' Hospital Research Ethics Committee, 25/02/2008, ref: 08/H0802/3

Study design

Parallel design, double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information material can be found at http://www.medscinet.net/marina/patientinfo.aspx

Condition

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

Phase

Not Applicable

Drug names

Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), polyunsaturated fatty acids

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women, aged 45 - 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant 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)

Recruitment start date

01/06/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nutritional Science Division
London
SE1 9NH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Franklin-Wilkins Building
150 Stamford Street
LONDON
SE1 9NH
United Kingdom
+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

Food Standards Agency (UK) (ref: N2041)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Sanders TA, Hall WL, Maniou Z, Lewis F, Seed PT, Chowienczyk PJ, Effect of low doses of long-chain n-3 PUFAs on endothelial function and arterial stiffness: a randomized controlled trial., Am. J. Clin. Nutr., 2011, 94, 4, 973-980, doi: 10.3945/ajcn.111.018036.

  2. Genetic analysis results

    Alsaleh A, Crepostnaia D, Maniou Z, Lewis FJ, Hall WL, Sanders TA, O'Dell SD, , Adiponectin gene variant interacts with fish oil supplementation to influence serum adiponectin in older individuals., J. Nutr., 2013, 143, 7, 1021-1027, doi: 10.3945/jn.112.172585.

  3. Results

    AlSaleh A, Maniou Z, Lewis FJ, Hall WL, Sanders TA, O'Dell SD, , Interaction between a CSK gene variant and fish oil intake influences blood pressure in healthy adults., J. Nutr., 2014, 144, 3, 267-272, doi: 10.3945/jn.113.185108.

Additional files

Editorial Notes