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

Atherosclerosis Clinical Trial

Official title:

Influence of Dietary Omega-3 Fatty Acids in a Convenience Drink (Smartfish) on the Omega-3 Index in Patients With Atherosclerotic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886704
• Other study ID #: 477-08
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: September 29, 2011
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

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

Locations

Country	Name	City	State
Germany	Preventive Cardiology	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Köhler A, Bittner D, Löw 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 Index	Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.	after eight weeks of intervention	No
Secondary	Palatability	Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome	at 8 weeks	Yes