Evaluation of the Safety and Biologic Effects of an Eicos... | NCT00988585

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

NCT00988585

Sponsor

Cardiovascular Research Associates

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

120Estimated

Phase

Phase 1

Conditions

Heart Disease

Interventions

EPA 600
EPA 1800
Olive Oil
DHA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 30, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
Dupont Applied Biosciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olive Oil	Placebo Comparator	Olive Oil 600 mg/day	Dietary Supplement: Olive Oil
EPA 1800	Active Comparator	1800 mg/day	Dietary Supplement: EPA 1800
DHA	Active Comparator	DHA 600 mg/day	Dietary Supplement: DHA
EPA 600	Active Comparator	EPA 600 mg/day	Dietary Supplement: EPA 600

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPA 600	Dietary Supplement	EPA 600 mg/day for 6 weeks	EPA 600	omega 3 fat

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael L Dansiner, M.D.	Cardiovascular Research Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Research Associates		Boston	Massachusetts	02111	United States

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005395	Fish Oils
D000069463	Olive Oil
D019301	Oleic Acid

Ancestor Terms

ID	Term
D009821	Oils
D008055	Lipids
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats

Browse Leaves

Not provided

Browse Branches

Not provided