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

This study is currently recruiting participants.
Verified September 2012 by Enzymotec
Sponsor:
Collaborator:
Daewon Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Enzymotec
ClinicalTrials.gov Identifier:
NCT01712867
First received: October 18, 2012
Last updated: February 12, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Patients With Hypertriglyceridemia
Other: Omega-3 acid ethyl esters
Other: Phytosterol esters of omega-3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • fasting triglycerides levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.


Secondary Outcome Measures:
  • Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels


Estimated Enrollment: 206
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712867

Locations
Israel
Maccabi Healthcare Services Recruiting
Tel-Aviv, Israel
Contact: Yossi Azuri, M.D    97235143738    Azuri_yo@mac.org.il   
Contact: Daphna Zaaroor-Regev, PhD    972747177155    Daphna@enzymotec.com   
Sponsors and Collaborators
Enzymotec
Daewon Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Yossi Azuri, MD Maccabi Healthcare Services, Israel
  More Information

No publications provided

Responsible Party: Enzymotec
ClinicalTrials.gov Identifier: NCT01712867     History of Changes
Other Study ID Numbers: Vayarol_006
Study First Received: October 18, 2012
Last Updated: February 12, 2014
Health Authority: Israel: Research Ethics Committee

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 20, 2014