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

Phase 4

Completed

Interventions: Dietary Supplement: Plant sterols esters
Dietary Supplement: placebo

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Plant sterol esters	Plant sterols esters	plant sterols esterified to fish oil fatty acids
placebo	placebo	Corn oil

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	at baseline	Average of blood test results at -10 and 0 days (before and after run-in period)
LDL-C	12 weeks	Blood test results following 12 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Triglycerides	12 weeks	Blood test results following 12 weeks of intervention
Total Cholesterol	12 weeks	Blood test results following 12 weeks of intervention
HDL Cholesterol	at baseline	Average of blood test results at -10 and 0 weeks (before and after run-in period)
HDL-cholestrol	12 weeks	Blood test results following 12 weeks of intervention
CRP	12 weeks	Blood test results following 12 weeks of intervention of High sensetivity C reactive protein
Apolipoprotein B100	12 weeks	Blood test results follwing 12 weeks of intervention
Apolipoprotein A	12 weeks	Blood test results following 12 weeks of intervention