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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Plant sterols esters
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant sterol esters<br>plant sterols esterified to fish oil fatty acids | Dietary Supplement: Plant sterols esters<br>* 1.6g phytosterols and 1.3g omega-3 fatty acids per day<br>* Other names: PS-FO;|
| Placebo Comparator: placebo<br>Corn oil | Dietary Supplement: placebo<br>* 4 gr of corn oil<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline | 
| Triglycerides | Blood test results following 12 weeks of intervention | 12 weeks | 
| Total Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline | 
| Total Cholesterol | Blood test results following 12 weeks of intervention | 12 weeks | 
| HDL Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline | 
| HDL-cholestrol | Blood test results following 12 weeks of intervention | 12 weeks | 
| CRP | Blood test results on day 0 of High sensitivity C Reactive Protein | at baseline | 
| CRP | Blood test results following 12 weeks of intervention of High sensetivity C reactive protein | 12 weeks | 
| Apolipoprotein B100 | Blood test results on day 0 | at baseline | 
| Apolipoprotein B100 | Blood test results follwing 12 weeks of intervention | 12 weeks | 
| Apolipoprotein A | Blood test on day 0 | at baseline | 
| Apolipoprotein A | Blood test results following 12 weeks of intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercholesterolemia, Hypertriglyceridemia, Plant sterol, Cholesterol, Fish oil