Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00988585

Acronym

EPA

Enrollment

120

Registered

2009-10-02

Start date

2009-04-30

Completion date

2009-12-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

Heart Disease Risk Reduction

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.

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.

Interventions

DIETARY_SUPPLEMENTEPA 600

EPA 600 mg/day for 6 weeks

DIETARY_SUPPLEMENTEPA 1800

1800 mg/day for 6 weeks

DIETARY_SUPPLEMENTOlive Oil

600 mg/day for 6 weeks

DIETARY_SUPPLEMENTDHA

600 mg/day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy male or surgically sterile females between ages 21-70. * BMI of 20-35.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.	6 weeks

Secondary

Measure	Time frame
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026