Effect of Plant Stanols on Cholesterol Absorption (DOSE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency|
- cholesterol absorption efficiency
- changes in blood lipids
|Study Start Date:||March 2007|
|Study Completion Date:||May 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441857
|Oy Foodfiles Ltd|
|Kuopio, Finland, 70210|
|Principal Investigator:||Sakari A Nieminen, MD||Oy Foodfiles Ltd|