Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides (OMEGA)

February 13, 2018 updated by: Sheila G West, Penn State University

Omacor: Measures of Endothelial Function and triGlyceride Alteration

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • triglycerides 150-500 mg/dL
  • age 21-65 years
  • generally healthy
  • body mass index (BMI) 20-39 kg/m2

Exclusion Criteria:

  • smoking
  • premenopausal (if female)
  • use of hormone replacement or oral contraceptives
  • use of lipid lowering or blood pressure medication
  • hypertension (blood pressure > 150/95 mm Hg)
  • peripheral vascular disease
  • heart disease, diabetes, or stroke
  • inflammatory disease (e.g. rheumatoid arthritis or Crohn's)
  • elevated liver enzymes
  • high intake of omega-3 containing foods
  • allergy to adhesive or latex
  • use of aspirin, anticoagulants, or SSRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4g P-OM3, then 1g P-OM3, then Placebo
4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil
Experimental: 1g P-OM3, then 4g P-OM3, then Placebo
1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil
Experimental: Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil
Experimental: 4g P-OM3, then Placebo, then 1g P-OM3
4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil
Experimental: 1g P-OM3, then Placebo, then 4g P-OM3
1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil
Experimental: Placebo, then 1g P-OM3, then 4g P-OM3
Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
Drug: 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • Lovaza
  • Fish oil
  • OM3AEE
Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Names:
  • Corn oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid Profile
Time Frame: 8 weeks
Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.
8 weeks
Flow-mediated Dilation (FMD)
Time Frame: 8 weeks
Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.
8 weeks
Blood Pressure
Time Frame: 8 weeks
Effect of P-OM3 dose on blood pressure
8 weeks
Heart Rate
Time Frame: 8 weeks
Effect of P-OM3 dose on heart rate
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythrocyte Fatty Acids
Time Frame: 8 weeks
Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
8 weeks
Cytokine Inflammatory Markers
Time Frame: 8 weeks
Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
8 weeks
Fasting Glucose
Time Frame: 8 weeks
Effect of P-OM3 dose on fasting glucose
8 weeks
Psychosocial Profile Questionnaires
Time Frame: 8 weeks

Effect of P-OM3 dose on psychosocial questionnaires:

Perceived Stress Scale (PSS)

  • 14 questions, scored 0-4 based on how often the subject felt certain emotions
  • Scores: 0 to 40; higher scores indicate higher perceived stress

Spielberger State Anxiety Inventory

  • Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale
  • Scores: 20 to 80; higher scores indicate higher levels of anxiety

Positive and Negative Affect Scales (PANAS)

  • Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much).
  • Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect

Center for Epidemiologic Studies Depression (CES-D) Scale

  • 20 questions about symptoms of depression in the past week
  • Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional
8 weeks
C-reactive Protein (CRP)
Time Frame: 8 weeks
Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
8 weeks
Fasting Insulin
Time Frame: 8 weeks
Effect of P-OM3 dose on fasting insulin
8 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
Time Frame: 8 weeks

Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).

HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405.

QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Reliant Pharmaceuticals

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University
  • Principal Investigator: Sheila G West, PhD, Penn State University
  • Principal Investigator: Ann C Skulas-Ray, B.S., Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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