The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.

Official Title
-----------------
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels in Hypertriglyceridemia Patients: A Double-blind, Randomized, Noninferiority Trial

Conditions
-----------------
Patients With Hypertriglyceridemia

Intervention / Treatment
-----------------
* Other: Omega-3 acid ethyl esters
* Other: Phytosterol esters of omega-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age > 18 years Triglycerides ≥ 200 mg/dL and < 500 mg/dL Ability to give written informed consent Exclusion Criteria: Female patient who are pregnant or breastfeeding or planning to become pregnant Fasting plasma glucose (FPG) levels > 110 mg/dL Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin [HbAlc ] >8.0% Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects History of bariatric surgery or currently on weight loss drugs. Uncontrolled hypertension (BP>140/90) Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH<0.35 or TSH>5.5) Subjects with an abnormal level of liver enzymes (twice the normal level) Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem Subjects who have had any malignancy. Subjects who have had basal cell carcinoma that have been disease free for at least 3 years are eligible for the study. Consumption of one fish serving (200 grams) or sea food x2 a week or more. HIV infection by history History of hypersensitivity or allergy to fish, fish oil or soy BMI≥35 Weight change > 3 kg during the run-in period Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phytosterol esters of omega-3<br>4 capsules/day for 12 weeks | Other: Phytosterol esters of omega-3<br>* 4 capsules/day for 12 weeks<br>|
| Active Comparator: Omega-3 acid ethyl esters<br>4 capsules/day for 12 weeks | Other: Omega-3 acid ethyl esters<br>* 4 capsules/day for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting triglycerides levels | Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels | Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels | 12 weeks |