Status:
COMPLETED
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
Lead Sponsor:
Enzymotec
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations i...
Detailed Description
Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-abs...
Eligibility Criteria
Inclusion
- Male or female, \>18 years old and ≤ 70 years old, capable and willing to give written informed consent.
- Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides \> 150 mg/dl and \< 500 mg/dl, LDL-cholesterol \> 130 mg/dl and \< 190 mg/dl.
- Fasting plasma glucose (FPG) levels at the screening visit \< 110 mg/dl.
- Female patient who is of reproductive potential agree to use acceptable methods of birth control
- Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.
Exclusion
- Receiving medications or supplements known to affect lipid metabolism.
- Uncontrolled hypertension or thyroid disease.
- Consume unusual diets - will be determined at the discretion of the investigator.
- Gained or lost more than 3 kg during the run-in period.
- Patient has history of malignancy ≤ 5 years.
- Patients with clinical ischemic CV disease on treatment
- Consume 200 grams fish x 2 a week.
- Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
- Patient has type 1 or type 2 diabetes mellitus.
- Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- Patient has had active peptic ulcer disease within 3 months of visit 1.
- Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
- Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00441480
Start Date
March 1 2007
End Date
June 1 2008
Last Update
January 13 2012
Active Locations (1)
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1
Sheba medical center
Tel Litwinsky, Israel, 52621