Status:
COMPLETED
Lipid-lowering Effect of a Plant Stanol Ester Supplement Product
Lead Sponsor:
Raisio Group
Collaborating Sponsors:
Clinical Research Institute HUCH Ltd
Conditions:
Hypercholesterolemia
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- male and female over 18 years old
- serum LDL cholesterol \> 3.0 mmol/L
- BMI \< 35
- subjects must voluntarily sign the informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02221297
Start Date
May 1 2014
End Date
November 1 2014
Last Update
October 29 2015
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