NCT00441480

Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels

Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Enzymotec · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.

Detailed description

Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic. The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant sterols esters	1.6g phytosterols and 1.3g omega-3 fatty acids per day
DIETARY_SUPPLEMENT	placebo	4 gr of corn oil

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-03-01
• Last updated: 2012-01-13
• Results posted: 2009-08-14

Locations

1 site across 1 country: Israel