Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Raisio Group

Status

Completed

Conditions

Hyperlipidemias

Dyslipidemias

Hypercholesterolemia

Treatments

Dietary Supplement: Supplement product with plant stanol ester

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02221297

CL2014_035

Details and patient eligibility

About

Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

male and female over 18 years old
serum LDL cholesterol > 3.0 mmol/L
BMI < 35
subjects must voluntarily sign the informed consent

Exclusion criteria

subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
subjects with any hepatic or renal disorder according to medical history
subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
subjects who have history of temporal ischemic attack or stroke within six months prior to screening
subjects who have a history of cancer or other malignant disease within the past five years
subjects who are consuming more than 15 portions of alcohol / week
subjects who are pregnant or lactating
subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
subjects with intolerance to any ingredient of the test product