Skip to main content
OpenTrials
Completed

NCT Number: NCT01712867

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi Healthcare Services

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • History of hypersensitivity or allergy to fish, fish oil or soy
  • BMI≥35
  • Weight change > 3 kg during the run-in period
  • Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient

Treatment and study plan

Omega-3 acid ethyl esters

Other

4 capsules/day for 12 weeks

Phytosterol esters of omega-3

Other

4 capsules/day for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Enzymotec

Industry

Collaborators

  • Daewon Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.