Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Raisio Group103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

103

Conditions

Hypercholesterolemia Hyperlipidemias Dyslipidemias

Interventions

Supplement product with plant stanol esterDIETARY_SUPPLEMENT

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportional change in serum LDL cholesterol

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.

Time frame: 3 to 4 weeks

Secondary Outcomes

Proportional change in total cholesterol

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.

Time frame: 3 to 4 weeks

Proportional change in non-HDL-cholesterol

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.

Time frame: 3 to 4 weeks

Proportional change in serum triglycerides

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.

Time frame: 3 to 4 weeks

Proportional change in lipids in all study participants

Proportional change \[end of intervention - start of intervention\] in serum lipids in all study participants (ITT analysis)

Time frame: 3 to 4 weeks

Proportional change in lipids in subjects without metabolic derangements

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)

Data from ClinicalTrials.gov

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