Heart DiseasePhase 1EPANCT00988585
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
A Phase 1 study testing EPA 600, EPA 1800 and Olive Oil in people with Heart Disease, run by Cardiovascular Research Associates at 1 site in United States.
Trial summary
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. 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 600, EPA 1800 and Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2009
- Phase
- Phase 1
- 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.
- BMI of 20-35.
Who cannot join
- competitive exerciser.
- current smokers.
- 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 units/day).
- those consuming more than 3 oily fish species/week.
- those consuming > 2 drinks/day.
- those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes.
- those taking medications affecting serum lipids, body weight, or blood clotting.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Research Associates
Boston, Massachusetts, 02111
About this study
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Read the detailed description
The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory 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.
The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
- Conditions
- Heart Disease
- Being tested
- EPA 600, EPA 1800, Olive Oil, DHA
- Keywords
- Heart Disease Risk Reduction
- 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 600Dietary supplement
Also called omega 3 fat, fish oil
EPA 600 mg/day for 6 weeks
EPA 1800Dietary supplement
Also called omega 3 fat, fish oil
1800 mg/day for 6 weeks
Olive OilDietary supplement
Also called Oleic acid
600 mg/day for 6 weeks
DHADietary supplement
Also called omega 3 fat, fish oil
600 mg/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Olive Oil | Placebo comparator | Olive Oil 600 mg/day Receives: Dietary Supplement: Olive Oil |
| EPA 1800 | Active comparator | 1800 mg/day Receives: Dietary Supplement: EPA 1800 |
| DHA | Active comparator | DHA 600 mg/day Receives: Dietary Supplement: DHA |
| EPA 600 | Active comparator | EPA 600 mg/day Receives: Dietary Supplement: EPA 600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
Measured: 6 weeks
Secondary outcomes (1)
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
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 posted2 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Associates
- Sponsor type
- Research network
- Collaborators
- Dupont Applied Biosciences
- Investigators
- Michael L Dansiner, M.D., Principal investigator, Cardiovascular Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988585
- Sponsor's protocol ID
- Dupont-0609
- Acronym
- EPA
- Status last verified
- Jun 2011
- First submitted
- 30 Sep 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
- ClinicalTrials.gov ID
- NCT00988585
- Acronym / sponsor ID
- EPA / Dupont-0609
- Conditions
- Heart Disease
- Keywords
- Heart Disease Risk Reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cardiovascular Research AssociatesResearch network
- Collaborators
- Dupont Applied Biosciences
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Oct 2009 (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 is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Detailed description
The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory 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.
The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olive Oil | Placebo comparator | Dietary Supplement: Olive OilOlive Oil 600 mg/day |
| EPA 1800 | Active comparator | Dietary Supplement: EPA 18001800 mg/day |
| DHA | Active comparator | Dietary Supplement: DHADHA 600 mg/day |
| EPA 600 | Active comparator | Dietary Supplement: EPA 600EPA 600 mg/day |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male or surgically sterile females between ages 21-70.
- BMI of 20-35.
Key exclusion criteria (7 listed)
- competitive exerciser.
- current smokers.
- 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 units/day).
- those consuming more than 3 oily fish species/week.
- those consuming > 2 drinks/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 600Also: omega 3 fat, fish oilEPA 600 mg/day for 6 weeks | Dietary supplement | EPA 600 |
| EPA 1800Also: omega 3 fat, fish oil1800 mg/day for 6 weeks | Dietary supplement | EPA 1800 |
| Olive OilAlso: Oleic acid600 mg/day for 6 weeks | Dietary supplement | Olive Oil |
| DHAAlso: omega 3 fat, fish oil600 mg/day for 6 weeks | Dietary supplement | DHA |
Primary outcome
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
Time frame: 6 weeks
1 secondary outcome
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Michael L Dansiner, M.D. principal investigator
Cardiovascular Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPA 600, EPA 1800 and Olive Oil 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 2 inclusion and 7 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 23 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2011.