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

Enzymotec

Status and phase

Completed

Phase 4

Conditions

Dyslipidemia

Treatments

Dietary Supplement: Plant sterols esters

Dietary Supplement: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00441480

CardiaBeat_003

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.