Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
• Interventions: Dietary Supplement: Supplement product with plant stanol ester

• Registration Number: NCT02221297
• Lead Sponsor: Raisio Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo supplement product	Supplement product with plant stanol ester	-
Supplement product with plant stanol ester	Supplement product with plant stanol ester	-

Primary Outcome Measures

Name	Time	Method
Proportional change in serum LDL cholesterol	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

Secondary Outcome Measures

Name	Time	Method
Proportional change in serum triglycerides	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Proportional change in total cholesterol	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Proportional change in non-HDL-cholesterol	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Proportional change in lipids in all study participants	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum lipids in all study participants (ITT analysis)
Proportional change in lipids in subjects without metabolic derangements	3 to 4 weeks	Proportional change \[end of intervention - start of intervention\] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)