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

This study has been completed.
Sponsor:
Collaborator:
Dupont Applied Biosciences
Information provided by:
Cardiovascular Research Associates
ClinicalTrials.gov Identifier:
NCT00988585
First received: September 30, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Disease
 Dietary Supplement: EPA 600
Dietary Supplement: EPA 1800
Dietary Supplement: Olive Oil
Dietary Supplement: DHA
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by Cardiovascular Research Associates:

Primary Outcome Measures:
  • No change in safety laboratory tests including comprehensive metabolic profile and complete blood count. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Olive Oil
Olive Oil 600 mg/day
 Dietary Supplement: Olive Oil
600 mg/day for 6 weeks
Other Name: Oleic acid
Active Comparator: EPA 1800
1800 mg/day
 Dietary Supplement: EPA 1800
1800 mg/day for 6 weeks
Other Names:
  • omega 3 fat
  • fish oil
Active Comparator: DHA
DHA 600 mg/day
 Dietary Supplement: DHA
600 mg/day for 6 weeks
Other Names:
  • omega 3 fat
  • fish oil
Active Comparator: EPA 600
EPA 600 mg/day
 Dietary Supplement: EPA 600
EPA 600 mg/day for 6 weeks
Other Names:
  • omega 3 fat
  • fish oil

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988585

Locations
United States, Massachusetts
Cardiovascular Research Associates
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Cardiovascular Research Associates
Dupont Applied Biosciences
Investigators
Principal Investigator: Michael L Dansiner, M.D. Cardiovascular Research Associates
  More Information

No publications provided

Responsible Party: Michael Dansinger, MD, Cardiovascular Research Associates
ClinicalTrials.gov Identifier: NCT00988585     History of Changes
Other Study ID Numbers: Dupont-0609
Study First Received: September 30, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cardiovascular Research Associates:
Heart Disease Risk Reduction

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013