AtherosclerosisNCT00886704
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
A study testing 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA) in people with Atherosclerosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Dietary Omega-3 Fatty Acids in a Convenience Drink (Smartfish) on the Omega-3 Index in Patients With Atherosclerotic Disease
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
- Being tested
- 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA), Control convenience drink
- Keywords
- Omega-3 fatty acids, dietary supplementation, atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control convenience drinkDietary supplement
Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA); Dietary Supplement: Control convenience drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: after eight weeks of intervention
Secondary outcomes (1)
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
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Clemens von Schacky, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886704
- Sponsor's protocol ID
- 477-08
- Status last verified
- Jul 2009
- First submitted
- 21 Apr 2009
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20420756
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary Omega-3 Fatty Acids in a Convenience Drink (Smartfish) on the Omega-3 Index in Patients With Atherosclerotic Disease
- ClinicalTrials.gov ID
- NCT00886704
- Acronym / sponsor ID
- 477-08
- Conditions
- Atherosclerosis
- Keywords
- Omega-3 fatty acids, dietary supplementation, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 26 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convenience drink with EPA and DHA | Active comparator | Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)Daily consumption of 200 ml convenience drink, containing 0.5 g EPA and DHA (Omega-3 Fatty Acids) |
| Convenience drink without EPA and DHA | Placebo comparator | Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA), Dietary Supplement: Control convenience drinkDaily 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) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Convenience drink with EPA and DHA, Convenience drink without EPA and DHA |
| Control convenience drinkControl convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil. | Dietary supplement | Convenience drink without EPA and DHA |
Primary outcome
Omega-3 Index
Time frame: 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%.
1 secondary outcome
Palatability
Time frame: at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20420756Kohler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens von Schacky, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA) in people with Atherosclerosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 Index (time frame: after eight weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.