Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product

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 Overview

• Status: Completed
• Conditions: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Supplement product with plant stanol ester

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supplement product with plant stanol ester	Dietary supplement: Supplement product with plant stanol ester; 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
PLACEBO_COMPARATOR: Placebo supplement product	Dietary supplement: Supplement product with plant stanol ester; 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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)	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)	3 to 4 weeks

Collaborators and Investigators

• Sponsor: Raisio Group
• Collaborators: Clinical Research Institute HUCH Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (ESTIMATE): August 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: CL2014_035