Clinical trial NCT00441480: Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
Official title: Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Hypercholesterolemia
Hypertriglyceridemia
Plant sterol
Cholesterol
Fish oil
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in healthy hyperlipidemic subjects.

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-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.

The primary objective 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 in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: LDL Cholesterol
timeFrame: at baseline
measure: LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Triglycerides
timeFrame: at baseline
measure: Triglycerides
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: at baseline
measure: Total Cholesterol
timeFrame: 12 weeks
measure: HDL Cholesterol
timeFrame: at baseline
measure: HDL-cholestrol
timeFrame: 12 weeks
measure: CRP
timeFrame: at baseline
measure: CRP
timeFrame: 12 weeks
measure: Apolipoprotein B100
timeFrame: at baseline
measure: Apolipoprotein B100
timeFrame: 12 weeks
measure: Apolipoprotein A
timeFrame: at baseline
measure: Apolipoprotein A
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tel-HaShomer
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Dror Harats, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37. doi: 10.1007/s10557-010-6249-5.