Conditions: Primary Hypercholesterolemia
Keywords: cholesterol hypercholesterolemia omega 3
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: no

Brief summary:
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

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 P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Arms:
arm 1: P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment. arm 2: Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.

Interventions: intervention 1: P-OM3 intervention 2: Placebo
Intervention descriptions: intervention 1: 4 grams/day - 4 one gram capsules intervention 2: 4 grams/day - 4 one gram capsules

Protocol document: