Effect of Plant Stanol Esters on Blood Lipids

Not Applicable

Completed

• Conditions: Elevated Blood Lipids
• Interventions: Dietary Supplement: plant stanol ester

• Registration Number: NCT00920894
• Lead Sponsor: Clinical Life Sciences Ltd.

Brief Summary

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Detailed Description

The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-04
• Last Update Posted: 2009-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Elevated blood lipids
• Body Mass Index < 35 kg/m2
• Stable body weight

Exclusion Criteria

• Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
• Severe obesity
• Hyperglycemia
• Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
• Hepatic, kidney or thyroid disease or disorder
• Pregnancy or breast feeding
• Severe intolerance or allergy to any ingredient of test product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
yoghurt type minidrink containing plant stanol ester	plant stanol ester	-
yoghurt type minidrink without plant stanol ester	plant stanol ester	-

Primary Outcome Measures

Name	Time	Method
plasma lipids	10 weeks

Secondary Outcome Measures

Name	Time	Method
plasma lipoprotein lipids non-cholesterol sterols	10 weeks

Trial Locations

Locations (1)

Clinical Life Sciences Ltd; 🇫🇮 Vuokatti, Finland