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

Provident Clinical Research

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Drug: POM3; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01034540

PRV-09009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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23 participants in 2 patient groups, including a placebo group

POM3

Experimental group

Description:

POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment

Treatment:

Drug: POM3

Placebo

Placebo Comparator group

Description:

Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment

Treatment:

Drug: Placebo