Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
EPA
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 23, 2011
June 1, 2011
8 months
September 30, 2009
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
6 weeks
Secondary Outcomes (1)
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
6 weeks
Study Arms (4)
Olive Oil
PLACEBO COMPARATOROlive Oil 600 mg/day
EPA 1800
ACTIVE COMPARATOR1800 mg/day
DHA
ACTIVE COMPARATORDHA 600 mg/day
EPA 600
ACTIVE COMPARATOREPA 600 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- healthy male or surgically sterile females between ages 21-70.
- BMI of 20-35.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiovascular Research Associateslead
- Dupont Applied Biosciencescollaborator
Study Sites (1)
Cardiovascular Research Associates
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Dansiner, M.D.
Cardiovascular Research Associates
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 2, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 23, 2011
Record last verified: 2011-06