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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Hypertriglyceridemia
• Intervention / Treatment: Other: Phytosterol esters of omega-3; Other: Omega-3 acid ethyl esters

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Maccabi Healthcare Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Enzymotec
• Collaborators: Daewon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yossi Azuri, MD, Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 21, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: Vayarol_006