Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441857
Status:
COMPLETED
Last Update Posted:
2007-07-06
First Post:
2007-02-28
Brief Title:
Effect of Plant Stanols on Cholesterol Absorption
Sponsor:
Oy Foodfiles Ltd
Organization:
Oy Foodfiles Ltd
Study Overview
Official Title:
The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOSE
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 08 16 and 20g 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 ie 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
Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols 08 16 and 20g 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None