search
Back to results

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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4/day of 4g P-OM3 capsules
4/day of 1g P-OM3 capsules
Corn Oil Placebo, 4 capsules/day for 8 weeks
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertriglyceridemia focused on measuring triglycerides, hypertriglyceridemia, omega-3, n-3, eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, flow mediated dilation, fish, Moderate hypertriglyceridemia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

4g P-OM3, then 1g P-OM3, then Placebo

1g P-OM3, then 4g P-OM3, then Placebo

Placebo, then 4g P-OM3, then 1g P-OM3

4g P-OM3, then Placebo, then 1g P-OM3

1g P-OM3, then Placebo, then 4g P-OM3

Placebo, then 1g P-OM3, then 4g P-OM3

Arm Description

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).

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Lipid Profile
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.
Flow-mediated Dilation (FMD)
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.
Blood Pressure
Effect of P-OM3 dose on blood pressure
Heart Rate
Effect of P-OM3 dose on heart rate

Secondary Outcome Measures

Erythrocyte Fatty Acids
Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Cytokine Inflammatory Markers
Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Fasting Glucose
Effect of P-OM3 dose on fasting glucose
Psychosocial Profile Questionnaires
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
C-reactive Protein (CRP)
Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Fasting Insulin
Effect of P-OM3 dose on fasting insulin
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
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)).

Full Information

First Posted
July 19, 2007
Last Updated
February 13, 2018
Sponsor
Penn State University
Collaborators
Reliant Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00504309
Brief Title
Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
Acronym
OMEGA
Official Title
Omacor: Measures of Endothelial Function and triGlyceride Alteration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
Reliant Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
triglycerides, hypertriglyceridemia, omega-3, n-3, eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, flow mediated dilation, fish, Moderate hypertriglyceridemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4g P-OM3, then 1g P-OM3, then Placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
1g P-OM3, then 4g P-OM3, then Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, then 4g P-OM3, then 1g P-OM3
Arm Type
Experimental
Arm Description
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.
Arm Title
4g P-OM3, then Placebo, then 1g P-OM3
Arm Type
Experimental
Arm Description
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.
Arm Title
1g P-OM3, then Placebo, then 4g P-OM3
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, then 1g P-OM3, then 4g P-OM3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
4/day of 4g P-OM3 capsules
Other Intervention Name(s)
OM3AEE, Lovaza, Fish oil
Intervention Description
4/day of 4g P-OM3 capsules for 8 weeks
Intervention Type
Drug
Intervention Name(s)
4/day of 1g P-OM3 capsules
Other Intervention Name(s)
OM3AEE, Lovaza, Fish oil
Intervention Description
4/day of 1g P-OM3 capsules for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Corn Oil Placebo, 4 capsules/day for 8 weeks
Other Intervention Name(s)
Corn oil
Intervention Description
4 capsules per day of corn oil placebo for 8 weeks
Primary Outcome Measure Information:
Title
Lipid Profile
Description
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.
Time Frame
8 weeks
Title
Flow-mediated Dilation (FMD)
Description
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.
Time Frame
8 weeks
Title
Blood Pressure
Description
Effect of P-OM3 dose on blood pressure
Time Frame
8 weeks
Title
Heart Rate
Description
Effect of P-OM3 dose on heart rate
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Erythrocyte Fatty Acids
Description
Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Time Frame
8 weeks
Title
Cytokine Inflammatory Markers
Description
Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Time Frame
8 weeks
Title
Fasting Glucose
Description
Effect of P-OM3 dose on fasting glucose
Time Frame
8 weeks
Title
Psychosocial Profile Questionnaires
Description
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
Time Frame
8 weeks
Title
C-reactive Protein (CRP)
Description
Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Time Frame
8 weeks
Title
Fasting Insulin
Description
Effect of P-OM3 dose on fasting insulin
Time Frame
8 weeks
Title
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)
Description
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)).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila G West, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Penny M Kris-Etherton, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann C Skulas-Ray, B.S.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University General Clinical Research Center
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23592752
Citation
Sauder KA, Skulas-Ray AC, Campbell TS, Johnson JA, Kris-Etherton PM, West SG. Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia. Psychosom Med. 2013 May;75(4):382-9. doi: 10.1097/PSY.0b013e318290a107. Epub 2013 Apr 16.
Results Reference
derived
PubMed Identifier
22865498
Citation
Skulas-Ray AC, Kris-Etherton PM, Harris WS, West SG. Effects of marine-derived omega-3 fatty acids on systemic hemodynamics at rest and during stress: a dose-response study. Ann Behav Med. 2012 Dec;44(3):301-8. doi: 10.1007/s12160-012-9393-2.
Results Reference
derived
PubMed Identifier
21159789
Citation
Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs