Back to resultsOmega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)
Control convenience drink
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis focused on measuring Omega-3 fatty acids, dietary supplementation, atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
- 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
Sites / Locations
- Preventive Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Convenience drink with EPA and DHA
Convenience drink without EPA and DHA
Arm Description
Daily consumption of 200 ml convenience drink, containing 0.5 g EPA and DHA (Omega-3 Fatty Acids)
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)
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00886704
First Posted
April 21, 2009
Last Updated
September 29, 2011
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00886704
Brief Title
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
Official Title
Influence of Dietary Omega-3 Fatty Acids in a Convenience Drink (Smartfish) on the Omega-3 Index in Patients With Atherosclerotic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Omega-3 fatty acids, dietary supplementation, atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Convenience drink with EPA and DHA
Arm Type
Active Comparator
Arm Description
Daily consumption of 200 ml convenience drink, containing 0.5 g EPA and DHA (Omega-3 Fatty Acids)
Arm Title
Convenience drink without EPA and DHA
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Dietary Supplement
Intervention Name(s)
500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)
Intervention Description
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
Intervention Name(s)
Control convenience drink
Intervention Description
Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
Primary Outcome Measure Information:
Title
Omega-3 Index
Description
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%.
Time Frame
after eight weeks of intervention
Secondary Outcome Measure Information:
Title
Palatability
Description
Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome
Time Frame
at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens von Schacky, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preventive Cardiology
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20420756
Citation
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.
Results Reference
result
Learn more about this trial
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
We'll reach out to this number within 24 hrs