Effect of Plant Stanols on Cholesterol Absorption

Phase 4

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00441857
• Lead Sponsor: Oy Foodfiles Ltd

Brief Summary

This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations

Detailed Description

Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.

Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.

Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.

Study Timeline

• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study Start: 2007-03
• Study First Posted: 2007-03-01
• Study Completion: 2007-05
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-04
• Last Update Posted: 2007-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• healthy adults with mild to moderate hypercholesterolemia

Exclusion Criteria

• lipid lowering medication
• pregnancy or lactation
• severe diseases (inc. diabetes, unstable CVD, malignant diseases)
• severe obesity
• regular plant sterol consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cholesterol absorption efficiency

Secondary Outcome Measures

Name	Time	Method
changes in blood lipids

Trial Locations

Locations (1)

Oy Foodfiles Ltd; 🇫🇮 Kuopio, Finland