Heart DiseaseNCT01400490
Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study
A study testing EPA-DHA Study in people with Heart Disease, run by Cardiovascular Research Associates at 1 site in United States.
Trial summary
The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- EPA-DHA Study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or surgically sterile females between ages 21-70.
- Body Mass Index of 20-35.
- Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values > 200 ng/ml.
Who cannot join
- Competitive exerciser.
- Current smoker.
- Those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (>500 mg/day) or vitamin E (>400 mg/day).
- Those consuming more than 3 oily fish species/week.
- Those consuming >2 drinks containing alcohol/day.
- Those taking medications which could affect serum lipids or body weight, or taking coumadin or more than 325 mg/day of aspirin which could effect bleeding time or the coagulation profile.
Show all 9Show fewer
- History of a bleeding disorder.
- History of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders including uncontrolled diabetes, thyroid disease, or hypertension.
- Plasma LpPLA2 values < 200 ng/ml.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Research Associates
Boston, Massachusetts, 02112
About this study
Official title: Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.
- Conditions
- Heart Disease
- Being tested
- EPA-DHA Study
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA-DHA StudyDietary supplement
6 weeks of dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| Olive Oil 6 grams/day | Placebo comparator | Not described Receives: Dietary Supplement: EPA-DHA Study |
| DHA 1800 mg/day | Active comparator | Not described Receives: Dietary Supplement: EPA-DHA Study |
| EPA 1800 mg/day | Active comparator | Not described Receives: Dietary Supplement: EPA-DHA Study |
| Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day | Active comparator | Not described Receives: Dietary Supplement: EPA-DHA Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
Subjects receiving EPA at 1800 mg/day will have significantly greater plasma EPA levels as well as the EPA/DHA ratio than the placebo group or the group receiving DHA, while the group receiving DHA will have significantly greater increases in plasma DHA levels as well as the DHA/EPA ratio than the placebo group or the group receiving EPA.
Measured: Six weeks
Secondary outcomes (1)
LpPLA2
Subjects receiving the active supplement, especially at the 1800 mg daily dose of EPA will have significant reductions in LpPLA2 as compared to both baseline values and to the placebo group.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Associates
- Sponsor type
- Research network
- Collaborators
- Dupont Applied Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400490
- Sponsor's protocol ID
- CVRA 2010-01
- Status last verified
- Jul 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsunoda F, Lamon-Fava S, Asztalos BF, Iyer LK, Richardson K, Schaefer EJ. Effects of oral eicosapentaenoic acid versus docosahexaenoic acid on human peripheral blood mononuclear cell gene expression. Atherosclerosis. 2015 Aug;241(2):400-8. doi: 10.1016/j.atherosclerosis.2015.05.015. Epub 2015 May 19.
PubMed 26074314
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
- ClinicalTrials.gov ID
- NCT01400490
- Acronym / sponsor ID
- CVRA 2010-01
- Conditions
- Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cardiovascular Research AssociatesResearch network
- Collaborators
- Dupont Applied Biosciences
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olive Oil 6 grams/day | Placebo comparator | Dietary Supplement: EPA-DHA Study |
| DHA 1800 mg/day | Active comparator | Dietary Supplement: EPA-DHA Study |
| EPA 1800 mg/day | Active comparator | Dietary Supplement: EPA-DHA Study |
| Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day | Active comparator | Dietary Supplement: EPA-DHA Study |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or surgically sterile females between ages 21-70.
- Body Mass Index of 20-35.
- Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values > 200 ng/ml.
Key exclusion criteria (9 listed)
- Competitive exerciser.
- Current smoker.
- Those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (>500 mg/day) or vitamin E (>400 mg/day).
- Those consuming more than 3 oily fish species/week.
- Those consuming >2 drinks containing alcohol/day.
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 |
|---|---|---|
| EPA-DHA Study6 weeks of dietary supplementation | Dietary supplement | DHA 1800 mg/day, EPA 1800 mg/day, Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day, Olive Oil 6 grams/day |
Primary outcome
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
Time frame: Six weeks
Subjects receiving EPA at 1800 mg/day will have significantly greater plasma EPA levels as well as the EPA/DHA ratio than the placebo group or the group receiving DHA, while the group receiving DHA will have significantly greater increases in plasma DHA levels as well as the DHA/EPA ratio than the placebo group or the group receiving EPA.
1 secondary outcome
LpPLA2
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Derived from this study: PubMed 26074314Tsunoda F, Lamon-Fava S, Asztalos BF, Iyer LK, Richardson K, Schaefer EJ. Effects of oral eicosapentaenoic acid versus docosahexaenoic acid on human peripheral blood mononuclear cell gene expression. Atherosclerosis. 2015 Aug;241(2):400-8. doi: 10.1016/j.atherosclerosis.2015.05.015. Epub 2015 May 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA-DHA Study in people with Heart Disease, run by Cardiovascular Research Associates at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 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 United States. 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?
Results are not available in the source record.
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?
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio (time frame: Six weeks). 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 NCT01400490, 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 22 Jul 2011.