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

Heart Disease Clinical Trial

— EPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988585
• Other study ID #: Dupont-0609
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2009
• Last updated: June 22, 2011
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Cardiovascular Research Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Dietary Supplement:
• EPA 600
EPA 600 mg/day for 6 weeks
• EPA 1800
1800 mg/day for 6 weeks
• Olive Oil
600 mg/day for 6 weeks
• DHA
600 mg/day for 6 weeks

Locations

Country	Name	City	State
United States	Cardiovascular Research Associates	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Research Associates	Dupont Applied Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.		6 weeks	Yes
Secondary	Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.		6 weeks	No