Conditions: Hypertriglyceridemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: no

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.

Arms:
arm 1: POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment arm 2: Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment

Interventions: intervention 1: POM3 intervention 2: Placebo
Intervention descriptions: intervention 1: 4 g/day intervention 2: matching placebo capsule, 4 g/day

Protocol document: