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

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ClinicalTrials.gov Identifier: NCT00504309
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by (Responsible Party):
Sheila G West, Penn State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: 4/day of 4g P-OM3 capsules Drug: 4/day of 1g P-OM3 capsules Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Omacor: Measures of Endothelial Function and triGlyceride Alteration
Study Start Date : July 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Corn oil

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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: 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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: 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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: 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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: 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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: 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:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
Other Names:
  • OM3AEE
  • Lovaza
  • Fish oil

Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Other Name: Corn oil




Primary Outcome Measures :
  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 Outcome Measures :
  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)).




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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00504309


Locations
United States, Pennsylvania
Penn State University General Clinical Research Center
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Reliant Pharmaceuticals
Investigators
Principal Investigator: Sheila G West, PhD Penn State University
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
Principal Investigator: Ann C Skulas-Ray, B.S. Penn State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila G West, Professor of Biobehavioral Health, Penn State University
ClinicalTrials.gov Identifier: NCT00504309     History of Changes
Other Study ID Numbers: G214
First Posted: July 20, 2007    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018

Keywords provided by Sheila G West, Penn State University:
triglycerides
hypertriglyceridemia
omega-3
n-3
eicosapentaenoic acid
EPA
docosahexaenoic acid
DHA
flow mediated dilation
fish
Moderate hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases