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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled, Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Acid Ethyl Esters on Indices of Glucose Homeostasis and Lipoprotein Lipids in Subjec

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 Summary: 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.
Sponsor: Provident Clinical Research

Current Primary Outcome: Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). [ Time Frame: End of Treatment Intervention Phase 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)


Original Primary Outcome: The primary outcome variable will be the difference between treatments in insulin sensitivity as determined by LMTT analysis. [ Time Frame: Week 6 and Week 14 ]

Current Secondary Outcome: Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. [ Time Frame: End of Treatment Intervention Phase 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



Original Secondary Outcome: Secondary outcome variables will be the difference between treatments in the insulin secretion index and the disposition index as determined by LMTT analysis. [ Time Frame: Week 6 and Week 14 ]

Information By: Provident Clinical Research

Dates:
Date Received: December 16, 2009
Date Started: March 2010
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013