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Effect of Plant Stanols on Cholesterol Absorption (DOSE)

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ClinicalTrials.gov Identifier: NCT00441857
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : July 6, 2007
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Study Description
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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Behavioral: plant stanol consumption Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
Study Start Date : March 2007
Study Completion Date : May 2007

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. cholesterol absorption efficiency

Secondary Outcome Measures :
  1. changes in blood lipids

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441857

Oy Foodfiles Ltd
Kuopio, Finland, 70210
Sponsors and Collaborators
Oy Foodfiles Ltd
Principal Investigator: Sakari A Nieminen, MD Oy Foodfiles Ltd
More Information

ClinicalTrials.gov Identifier: NCT00441857     History of Changes
Other Study ID Numbers: DOSE
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007

Keywords provided by Oy Foodfiles Ltd:
plant sterols
plant stanols
cholesterol absorption

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases