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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712867
Recruitment Status : Unknown
Verified September 2012 by Enzymotec.
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2012
Last Update Posted : August 7, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. fasting triglycerides levels [ Time Frame: 12 weeks ]
    Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.


Secondary Outcome Measures :
  1. 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 ]
    Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712867


Locations
Israel
Maccabi Healthcare Services
Tel-Aviv, Israel
Sponsors and Collaborators
Enzymotec
Daewon Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Yossi Azuri, MD Maccabi Healthcare Services, Israel
More Information

Responsible Party: Enzymotec
ClinicalTrials.gov Identifier: NCT01712867     History of Changes
Other Study ID Numbers: Vayarol_006
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: September 2012

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