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

Hypertriglyceridemia Clinical Trial

— OMEGA  

Official title:

Omacor: Measures of Endothelial Function and triGlyceride Alteration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504309
• Other study ID #: G214
• Status: Completed
• Phase: N/A
• First received: July 19, 2007
• Last updated: February 13, 2018
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2018
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• 4/day of 4g P-OM3 capsules
4/day of 4g P-OM3 capsules for 8 weeks
• 4/day of 1g P-OM3 capsules
4/day of 1g P-OM3 capsules for 8 weeks
• Corn Oil Placebo, 4 capsules/day for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks

Locations

Country	Name	City	State
United States	Penn State University General Clinical Research Center	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Reliant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Blood Pressure	Effect of P-OM3 dose on blood pressure	8 weeks
Primary	Heart Rate	Effect of P-OM3 dose on heart rate	8 weeks
Secondary	Erythrocyte Fatty Acids	Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells	8 weeks
Secondary	Cytokine Inflammatory Markers	Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma	8 weeks
Secondary	Fasting Glucose	Effect of P-OM3 dose on fasting glucose	8 weeks
Secondary	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	8 weeks
Secondary	C-reactive Protein (CRP)	Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP	8 weeks
Secondary	Fasting Insulin	Effect of P-OM3 dose on fasting insulin	8 weeks
Secondary	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)).	8 weeks