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Effect of Plant Stanols on Cholesterol Absorption

NCT ID: NCT00441857

Last Updated: 2007-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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plant stanol consumption

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oy Foodfiles Ltd

OTHER

Sponsor Role lead

Principal Investigators

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Sakari A Nieminen, MD

Role: PRINCIPAL_INVESTIGATOR

Oy Foodfiles Ltd

Locations

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Oy Foodfiles Ltd

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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DOSE

Identifier Type: -

Identifier Source: org_study_id