Atherosclerosis
Conditions
Keywords
Omega-3 fatty acids, dietary supplementation, atherosclerosis
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.
Interventions
DIETARY_SUPPLEMENT500 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.
DIETARY_SUPPLEMENTControl convenience drink
Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Omega-3 Index | after eight weeks of intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Palatability | at 8 weeks | Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome |
Countries
Germany
Participant flow
Recruitment details
190 subjects were screened and gave informed consent, and 50 were enrolled.
Pre-assignment details
The main reason for screen failure (about 95 %) was an omega-3 index \< 5.0%. Additional subjects were excluded because of the lack of any evidence for atherosclerotic disease, hospitalisation or lactose intolerance.
Participants by arm
| Arm | Count |
|---|---|
| Convenience Drink With EPA and DHA (Omega-3 Fatty Acids) | 40 |
| Convenience Drink Without EPA and DHA | 10 |
| Total | 50 |
Baseline characteristics
| Characteristic | Convenience Drink Without EPA and DHA | Convenience Drink With EPA and DHA (Omega-3 Fatty Acids) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 25 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 15 Participants | 20 Participants |
| Age Continuous | 64.5 years STANDARD_DEVIATION 5.9 | 65.1 years STANDARD_DEVIATION 6.1 | 64.8 years STANDARD_DEVIATION 6 |
| Region of Enrollment Germany | 10 participants | 40 participants | 50 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 29 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 10 |
| serious Total, serious adverse events | 0 / 40 | 0 / 10 |
Outcome results
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%.
Time frame: after eight weeks of intervention
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Convenience Drink With EPA and DHA | Omega-3 Index | 4.37 % EPA+DHA in total red cell fatty acids | Standard Deviation 0.51 |
| Convenience Drink Without EPA and DHA | Omega-3 Index | 4.71 % EPA+DHA in total red cell fatty acids | Standard Deviation 0.73 |
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
Time frame: at 8 weeks
Population: Per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Convenience Drink With EPA and DHA | Palatability | 8.50 Number on a scale from 0 - 10 | Standard Deviation 1.84 |
| Convenience Drink Without EPA and DHA | Palatability | 8.39 Number on a scale from 0 - 10 | Standard Deviation 1.71 |