Skip to content

Effect of Plant Stanols on Cholesterol Absorption

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00441857
Acronym
DOSE
Enrollment
60
Registered
2007-03-01
Start date
2007-03-31
Completion date
2007-05-31
Last updated
2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

plant sterols, plant stanols, cholesterol absorption

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.

Interventions

BEHAVIORALplant stanol consumption

Sponsors

Oy Foodfiles Ltd
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
25 Years to 68 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
cholesterol absorption efficiency

Secondary

MeasureTime frame
changes in blood lipids

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026