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

NCT ID: NCT00441480

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Plant sterol esters

plant sterols esterified to fish oil fatty acids

Group Type: ACTIVE_COMPARATOR

Plant sterols esters

Intervention Type: DIETARY_SUPPLEMENT

1.6g phytosterols and 1.3g omega-3 fatty acids per day

placebo

Corn oil

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

4 gr of corn oil

Interventions

Plant sterols esters

1.6g phytosterols and 1.3g omega-3 fatty acids per day

Intervention Type: DIETARY_SUPPLEMENT

placebo

4 gr of corn oil

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PS-FO

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Enzymotec LTD

Principal Investigators

Dror Harats, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba medical center

Tel Litwinsky, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 20617456 (View on PubMed)

Other Identifiers

CardiaBeat_003

Identifier Type: -

Identifier Source: org_study_id