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Completed

NCT Number: NCT00504309

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

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University General Clinical Research Center

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4/day of 4g P-OM3 capsules

Drug

4/day of 4g P-OM3 capsules for 8 weeks

Other names: OM3AEE, Lovaza, Fish oil

4/day of 1g P-OM3 capsules

Drug

4/day of 1g P-OM3 capsules for 8 weeks

Other names: OM3AEE, Lovaza, Fish oil

Corn Oil Placebo, 4 capsules/day for 8 weeks

Drug

4 capsules per day of corn oil placebo for 8 weeks

Other names: Corn oil

Primary outcomes

  1. 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.

  2. 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.

  3. Blood Pressure

    Time frame: 8 weeks

    Effect of P-OM3 dose on blood pressure

  4. Heart Rate

    Time frame: 8 weeks

    Effect of P-OM3 dose on heart rate

Secondary outcomes

  1. 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

  2. Cytokine Inflammatory Markers

    Time frame: 8 weeks

    Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma

  3. Fasting Glucose

    Time frame: 8 weeks

    Effect of P-OM3 dose on fasting glucose

  4. 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

  5. C-reactive Protein (CRP)

    Time frame: 8 weeks

    Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP

  6. Fasting Insulin

    Time frame: 8 weeks

    Effect of P-OM3 dose on fasting insulin

  7. 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)).

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Reliant Pharmaceuticals

Registry information

Official study title

Omacor: Measures of Endothelial Function and triGlyceride Alteration

Acronym: OMEGA

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 20, 2007
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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