Clinical trial NCT01712867: The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Hypertriglyceridemia
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
Collaborators: name: Daewon Pharmaceutical Co., Ltd.
First posted: 2012-10-24
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age \> 18 years
2. Triglycerides ≥ 200 mg/dL and \< 500 mg/dL
3. Ability to give written informed consent

Exclusion Criteria:

1. Female patient who are pregnant or breastfeeding or planning to become pregnant
2. Fasting plasma glucose (FPG) levels \> 110 mg/dL
3. Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin \[HbAlc \] \>8.0%
4. Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more
5. Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects
6. History of bariatric surgery or currently on weight loss drugs.
7. Uncontrolled hypertension (BP\>140/90)
8. Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH\<0.35 or TSH\>5.5)
9. Subjects with an abnormal level of liver enzymes (twice the normal level)
10. Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months
11. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome
12. Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem
13. 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.
14. Consumption of one fish serving (200 grams) or sea food x2 a week or more.
15. HIV infection by history
16. History of hypersensitivity or allergy to fish, fish oil or soy
17. BMI≥35
18. Weight change \> 3 kg during the run-in period
19. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient

Primary outcomes:
measure: fasting triglycerides levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Maccabi Healthcare Services
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Yossi Azuri, MD
role: PRINCIPAL_INVESTIGATOR
References: