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NCT00441857 Clinical Trial

Effect of Plant Stanols on Cholesterol Absorption

Hypercholesterolemia Clinical Trial

— DOSE  

Official title:
The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00441857
Other study ID # DOSE
Secondary ID
Status Completed
Phase Phase 4
First received February 28, 2007
Last updated July 4, 2007
Start date March 2007
Est. completion date May 2007

Study information
Verified date July 2007
Source Oy Foodfiles Ltd
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 68 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• plant stanol consumption

Locations
Country Name City State
Finland Oy Foodfiles Ltd Kuopio

Sponsors (1)
Lead Sponsor Collaborator
Oy Foodfiles Ltd

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary cholesterol absorption efficiency
Secondary changes in blood lipids
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