Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels

Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Plant sterols esters; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Tel-HaShomer, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plant sterol esters; plant sterols esterified to fish oil fatty acids	Dietary supplement: Plant sterols esters; 1.6g phytosterols and 1.3g omega-3 fatty acids per day; Other Names: PS-FO
Placebo Comparator: placebo; Corn oil	Dietary supplement: placebo; 4 gr of corn oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL Cholesterol	Average of blood test results at -10 and 0 days (before and after run-in period)	at baseline
LDL-C	Blood test results following 12 weeks of intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline
Triglycerides	Blood test results following 12 weeks of intervention	12 weeks
Total Cholesterol	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline
Total Cholesterol	Blood test results following 12 weeks of intervention	12 weeks
HDL Cholesterol	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline
HDL-cholestrol	Blood test results following 12 weeks of intervention	12 weeks
CRP	Blood test results on day 0 of High sensitivity C Reactive Protein	at baseline
CRP	Blood test results following 12 weeks of intervention of High sensetivity C reactive protein	12 weeks
Apolipoprotein B100	Blood test results on day 0	at baseline
Apolipoprotein B100	Blood test results follwing 12 weeks of intervention	12 weeks
Apolipoprotein A	Blood test on day 0	at baseline
Apolipoprotein A	Blood test results following 12 weeks of intervention	12 weeks

Collaborators and Investigators

• Sponsor: Enzymotec
• Investigators: Principal Investigator: Dror Harats, M.D., Sheba Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: February 28, 2007
• First Submitted That Met QC Criteria: February 28, 2007
• First Posted (Estimate): March 1, 2007

Study Record Updates

• Last Update Posted (Estimate): January 13, 2012
• Last Update Submitted That Met QC Criteria: January 12, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Cholesterol; Hypercholesterolemia; Fish oil; Plant sterol; Hypertriglyceridemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CardiaBeat_003