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

NCT ID: NCT01712867

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Patients With Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phytosterol esters of omega-3

4 capsules/day for 12 weeks

Group Type: EXPERIMENTAL

Phytosterol esters of omega-3

Intervention Type: OTHER

4 capsules/day for 12 weeks

Omega-3 acid ethyl esters

4 capsules/day for 12 weeks

Group Type: ACTIVE_COMPARATOR

Omega-3 acid ethyl esters

Intervention Type: OTHER

4 capsules/day for 12 weeks

Interventions

Omega-3 acid ethyl esters

4 capsules/day for 12 weeks

Intervention Type: OTHER

Phytosterol esters of omega-3

4 capsules/day for 12 weeks

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yossi Azuri, MD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

Locations

Maccabi Healthcare Services

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

Vayarol_006

Identifier Type: -

Identifier Source: org_study_id