Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Control convenience drink; Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00886704

477-08

Details and patient eligibility

About

An increase in intake of omega-3 fatty acids should increase the Omega-3 Index. Current evidence indicates that this may lead to a reduction in risk for sudden cardiac death and atherosclerotic diseases like myocardial infarction. The aim of the study is to investigate, how supplementing a convenience drink with omega-3 fatty acids influences the Omega-3 Index, as compared to an unsupplemented matching convenience drink. Palatability and safety of the drink are also to be assessed.

Enrollment: 50 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must meet the current guideline criteria for atherosclerosis, like coronary, peripheral or carotid artery disease, like previous myocardial infarction or acute coronary syndrome, coronary revascularization (operation or transluminally), or positive angiography or ultrasound.
2. Age: 30 - 75 years
3. Low Omega-3 Index (<5%)
4. Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
5. Stable intake of food containing EPA+DHA before and during study
6. Subjects must be able and willing to give written informed consent, and to comply with study procedures.

Exclusion criteria

1. Subjects for whom the intake of omega-3 fatty acids is mandatory according to recent treatment guidelines or who take omega-3 fatty acids supplements on a regular basis.
2. Patients consuming >2 portions of fatty fish / week
3. Patients with serious bleeding disorder. Use of platelet inhibitors or anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
4. Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
5. Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitis or a BMI>30
6. Allergy/intolerance or history of hypersensitivity to components of study intervention, like lactose.
7. Pregnant subjects - due to any possible teratogenic effects of study nutrition on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
8. Subjects who, in the investigator's judgement, will not likely be able to comply with the study protocol or with known drug- or alcohol abuse/dependence in the past 2 years.
9. Use of any investigational agents within 30 days prior to t0

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Convenience drink with EPA and DHA

Active Comparator group

Description:

Daily consumption of 200 ml convenience drink, containing 0.5 g EPA and DHA (Omega-3 Fatty Acids)

Treatment:

Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)

Convenience drink without EPA and DHA

Placebo Comparator group

Description:

Daily consumption of 200 ml convenience drink, not containing 0.5 g EPA and DHA (Omega-3 Fatty Acids), but containing 1.0 g of Omega-6 Fatty Acids (e.g. corn oil)

Treatment:

Dietary Supplement: Control convenience drink

Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)