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
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.
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.
Inclusion Criteria:

 -  Male or female, >18 years old and ≤ 70 years old, capable and willing to give written
 informed consent.

 -  Subject must have hyperlipidemia at the screening visit and at the end of the run-in
 period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl,
 LDL-cholesterol > 130 mg/dl and < 190 mg/dl.

 -  Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.

 -  Female patient who is of reproductive potential agree to use acceptable methods of
 birth control

 -  Female patient who is currently receiving hormone replacement therapy continuously 12
 weeks before visit 1 (on stable dose) and will agree to do so during the study.

 Exclusion Criteria:

 -  Receiving medications or supplements known to affect lipid metabolism.

 -  Uncontrolled hypertension or thyroid disease.

 -  Consume unusual diets - will be determined at the discretion of the investigator.

 -  Gained or lost more than 3 kg during the run-in period.

 -  Patient has history of malignancy ≤ 5 years.

 -  Patients with clinical ischemic CV disease on treatment

 -  Consume 200 grams fish x 2 a week.

 -  Gastrointestinal disease or any disease that the investigator feels would compromise
 the patient safety or limit his/her successful participation to the study.

 -  Patient has type 1 or type 2 diabetes mellitus.

 -  Patient has uncontrolled endocrine or metabolic disease known to influence serum
 lipids or lipoproteins

 -  Patient has had active peptic ulcer disease within 3 months of visit 1.

 -  Woman patient is pregnant or breast-feeding or expecting to conceive during the study.

 -  Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or
 soy.