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

2014-08-27 03:17:12 | BioPortfolio

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.

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 prescription omega-3 acid ethyl esters for the first 6 week phase followed by the study product they did not receive during the first phase (prescription omega-3 acid ethyl esters or placebo) for the second 6 weeks.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Hypertriglyceridemia

Intervention

prescription omega-3 acid ethyl esters, Placebo

Location

Provident Clinical Research
Addison
Illinois
United States
60101

Status

Not yet recruiting

Source

Provident Clinical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:12-0400

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Medical and Biotech [MESH] Definitions

Salts or esters of carbamic acid, H2NC(=O)OH, or of N-substituted carbamic acids: R2NC(=O)OR', (R' = hydrocarbyl or a cation). The esters are often called URETHANE or urethan, a usage that is strictly correct only for the ethyl esters. (From IUPAC [Internet]. International Union Of Pure And Applied Chemistry; c1995 [updated 2004 Jan 9; cited 2004 May 3]. Available from http://www.chem.qmul.ac.uk/iupac/class/oneN.html#35/).

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Salts or esters of acetic acid in which the terminal hydrogen atom is replaced by a metal, for instance copper acetate Cu(CH3COO)2, or where substitution is by a radical, for instance ethyl acetate CH3COOC2H5. (From Hawley's Condensed Chemical Dictionary, 12th ed)

Phosphoric acid esters of inositol. They include mono- and polyphosphoric acid esters, with the exception of inositol hexaphosphate which is PHYTIC ACID.

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