Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia

Not Applicable

Completed

Brief Summary: The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.

Detailed Description: This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.

Recruitment & Eligibility

Inclusion Criteria

Men and postmenopausal women, ages 18-79 years.
Fasting, triglyceride (TG) level in the borderline high to high range.
Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy
Provide written informed consent and authorization for protected health information

Exclusion Criteria

Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy.
Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with >1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA
coronary heart disease (CHD) or a CHD risk equivalent
Body mass index over 45 kg per square meter
Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug
Certain muscle, liver, kidney, lung or gastrointestinal conditions
Poorly controlled hypertension
Certain medications
Active cancers treated within prior 2 years (except non-melanoma skin cancer)

Arm && Interventions

Group	Intervention	Description
POM3	POM3	POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
Placebo	Placebo	Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment

Primary Outcome Measures

Name	Time	Method
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).	End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)	Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)

Secondary Outcome Measures

Name	Time	Method
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.	End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)	Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose. Disposition index = MISI x insulin secretion index