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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
4/day of 4g P-OM3 capsules for 8 weeks
4/day of 1g P-OM3 capsules for 8 weeks
4 capsules per day of corn oil placebo for 8 weeks
Penn State University General Clinical Research Center
University Park, Pennsylvania, United States
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Blood Pressure
Effect of P-OM3 dose on blood pressure
Time frame: 8 weeks
Heart Rate
Effect of P-OM3 dose on heart rate
Time frame: 8 weeks
Erythrocyte Fatty Acids
Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Time frame: 8 weeks
Cytokine Inflammatory Markers
Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Time frame: 8 weeks
Fasting Glucose
Effect of P-OM3 dose on fasting glucose
Time frame: 8 weeks
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
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Time frame: 8 weeks
C-reactive Protein (CRP)
Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Time frame: 8 weeks
Fasting Insulin
Effect of P-OM3 dose on fasting insulin
Time frame: 8 weeks
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)).
Time frame: 8 weeks