We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00988585
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Dupont Applied Biosciences
Information provided by:
Cardiovascular Research Associates

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.

Condition or disease Intervention/treatment Phase
Heart Disease Dietary Supplement: EPA 600 Dietary Supplement: EPA 1800 Dietary Supplement: Olive Oil Dietary Supplement: DHA Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
Study Start Date : April 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Dansinger, MD, Cardiovascular Research Associates
ClinicalTrials.gov Identifier: NCT00988585     History of Changes
Other Study ID Numbers: Dupont-0609
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Cardiovascular Research Associates:
Heart Disease Risk Reduction

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases