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

NCT00886704 | Completed Results

• 1 other identifier: 477-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Omega-3 fatty acids; dietary supplementation; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Palatability

  at 8 weeks

Study Arms (2)

Convenience drink with EPA and DHA

ACTIVE COMPARATOR

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

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

Convenience drink without EPA and DHA

PLACEBO COMPARATOR

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)

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

Interventions

500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA) 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 with EPA and DHA; Convenience drink without EPA and DHA

Control convenience drink DIETARY_SUPPLEMENT

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

Convenience drink without EPA and DHA

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age: 30 - 75 years
• Low Omega-3 Index (\<5%)
• Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
• Stable intake of food containing EPA+DHA before and during study
• Subjects must be able and willing to give written informed consent, and to comply with study procedures.

You may not qualify if:

• 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.
• Patients consuming \>2 portions of fatty fish / week
• Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
• Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitis or a BMI\>30
• Allergy/intolerance or history of hypersensitivity to components of study intervention, like lactose.
• 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.
• 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.
• Use of any investigational agents within 30 days prior to t0

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Preventive Cardiology

Munich, 80336, Germany

Location

Related Publications (1)

• 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.

  PMID: 20420756 RESULT

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Single center study, too small to detect rare side effects, 8 week intervention period relatively short.

Results Point of Contact

• Title: Clemens von Schacky, Head, Preventive Cardiology, University of Munich
• Organization: Ludwig Maximilians-University Munich

clemens.vonschacky@med.uni-muenchen.de

+498951600

Study Officials

• Clemens von Schacky, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 23, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 7, 2011
• Results First Posted: September 26, 2011

Record last verified: 2009-07

Locations

DE (1)