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

NCT00988585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-06-23

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

EPA 600

EPA 600 mg/day for 6 weeks

DIETARY_SUPPLEMENT

EPA 1800

1800 mg/day for 6 weeks

DIETARY_SUPPLEMENT

Olive Oil

600 mg/day for 6 weeks

DIETARY_SUPPLEMENT

DHA

600 mg/day for 6 weeks

Sponsors & Collaborators

  • Dupont Applied Biosciences

    collaborator INDUSTRY

  • Cardiovascular Research Associates

    lead NETWORK

Principal Investigators

  • Michael L Dansiner, M.D. · Cardiovascular Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988585 on ClinicalTrials.gov