Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
- Conditions
- Hypertriglyceridemia
- Interventions
- Drug: 4/day of 4g P-OM3 capsulesDrug: 4/day of 1g P-OM3 capsules
- Registration Number
- NCT00504309
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- triglycerides 150-500 mg/dL
- age 21-65 years
- generally healthy
- body mass index (BMI) 20-39 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, then 1g P-OM3, then 4g P-OM3 Corn Oil Placebo, 4 capsules/day for 8 weeks 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. 1g P-OM3, then 4g P-OM3, then Placebo Corn Oil Placebo, 4 capsules/day for 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. Placebo, then 4g P-OM3, then 1g P-OM3 Corn Oil Placebo, 4 capsules/day for 8 weeks 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. 1g P-OM3, then Placebo, then 4g P-OM3 Corn Oil Placebo, 4 capsules/day for 8 weeks 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. 1g P-OM3, then 4g P-OM3, then Placebo 4/day of 1g P-OM3 capsules 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. Placebo, then 4g P-OM3, then 1g P-OM3 4/day of 1g P-OM3 capsules 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. 1g P-OM3, then Placebo, then 4g P-OM3 4/day of 4g P-OM3 capsules 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. 4g P-OM3, then 1g P-OM3, then Placebo Corn Oil Placebo, 4 capsules/day for 8 weeks 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 P-OM3, then Placebo, then 4g P-OM3 4/day of 1g P-OM3 capsules 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. Placebo, then 1g P-OM3, then 4g P-OM3 4/day of 1g P-OM3 capsules 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. 4g P-OM3, then 1g P-OM3, then Placebo 4/day of 4g P-OM3 capsules 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 P-OM3, then 4g P-OM3, then Placebo 4/day of 4g P-OM3 capsules 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. 4g P-OM3, then Placebo, then 1g P-OM3 4/day of 4g P-OM3 capsules 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. 4g P-OM3, then 1g P-OM3, then Placebo 4/day of 1g P-OM3 capsules 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). Placebo, then 4g P-OM3, then 1g P-OM3 4/day of 4g P-OM3 capsules 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 P-OM3, then Placebo, then 1g P-OM3 Corn Oil Placebo, 4 capsules/day for 8 weeks 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. 4g P-OM3, then Placebo, then 1g P-OM3 4/day of 1g P-OM3 capsules 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. Placebo, then 1g P-OM3, then 4g P-OM3 4/day of 4g P-OM3 capsules 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.
- Primary Outcome Measures
Name Time Method Blood Pressure 8 weeks Effect of P-OM3 dose on blood pressure
Flow-mediated Dilation (FMD) 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.
Heart Rate 8 weeks Effect of P-OM3 dose on heart rate
Lipid Profile 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.
- Secondary Outcome Measures
Name Time Method Cytokine Inflammatory Markers 8 weeks Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma
Fasting Glucose 8 weeks Effect of P-OM3 dose on fasting glucose
Erythrocyte Fatty Acids 8 weeks Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells
Fasting Insulin 8 weeks Effect of P-OM3 dose on fasting insulin
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) 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)).Psychosocial Profile Questionnaires 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 professionalC-reactive Protein (CRP) 8 weeks Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP
Trial Locations
- Locations (1)
Penn State University General Clinical Research Center
🇺🇸University Park, Pennsylvania, United States