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

NCT ID: NCT00886704

Last Updated: 2011-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Convenience drink with EPA and DHA

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

Group Type: ACTIVE_COMPARATOR

500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)

Intervention Type: DIETARY_SUPPLEMENT

Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized..

Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug.

Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.

Convenience drink without EPA and DHA

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)

Group Type: PLACEBO_COMPARATOR

500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)

Intervention Type: DIETARY_SUPPLEMENT

Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized..

Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug.

Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.

Control convenience drink

Intervention Type: DIETARY_SUPPLEMENT

Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.

Interventions

500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)

Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized..

Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug.

Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.

Intervention Type: DIETARY_SUPPLEMENT

Control convenience drink

Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Preventive Cardiology, University of Munich

Principal Investigators

Clemens von Schacky, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Preventive Cardiology

Munich, , Germany

Countries

Germany

References

Kohler A, Bittner D, Low A, von Schacky C. Effects of a convenience drink fortified with n-3 fatty acids on the n-3 index. Br J Nutr. 2010 Sep;104(5):729-36. doi: 10.1017/S0007114510001054. Epub 2010 Apr 27.

Reference Type: RESULT

PMID: 20420756 (View on PubMed)

Other Identifiers

477-08

Identifier Type: -

Identifier Source: org_study_id