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

NCT01712867 | Completed

• 1 other identifier: Vayarol_006
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels

  12 weeks

Study Arms (2)

Phytosterol esters of omega-3

EXPERIMENTAL

4 capsules/day for 12 weeks

Other: Phytosterol esters of omega-3

Omega-3 acid ethyl esters

ACTIVE COMPARATOR

4 capsules/day for 12 weeks

Other: Omega-3 acid ethyl esters

Interventions

Omega-3 acid ethyl esters OTHER

4 capsules/day for 12 weeks

Omega-3 acid ethyl esters

Phytosterol esters of omega-3 OTHER

4 capsules/day for 12 weeks

Phytosterol esters of omega-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Female patient who are pregnant or breastfeeding or planning to become pregnant
• Fasting plasma glucose (FPG) levels \> 110 mg/dL
• Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin \[HbAlc \] \>8.0%
• Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more
• Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects
• History of bariatric surgery or currently on weight loss drugs.
• Uncontrolled hypertension (BP\>140/90)
• Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH\<0.35 or TSH\>5.5)
• Subjects with an abnormal level of liver enzymes (twice the normal level)
• Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome
• Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem
• 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.
• Consumption of one fish serving (200 grams) or sea food x2 a week or more.
• HIV infection by history

Sponsors & Collaborators

• Enzymotec: lead
• Daewon Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Maccabi Healthcare Services

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Omacor

Study Officials

• Yossi Azuri, MD

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 24, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IL (1)