Cardiovascular disease Circulatory System Complications and ill-defined descriptions of heart disease
Conditions
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
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women, aged 45 - 70 years
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in endothelial function measured by the flow-mediated dilatation technique and ambulatory blood pressure, measured at baseline and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed