Effect of Plant Stanols on Cholesterol Absorption (DOSE)

This study has been completed.
Sponsor:
Information provided by:
Oy Foodfiles Ltd
ClinicalTrials.gov Identifier:
NCT00441857
First received: February 28, 2007
Last updated: July 4, 2007
Last verified: July 2007
  Purpose

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 Intervention Phase
Hypercholesterolemia
Behavioral: plant stanol consumption
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency

Resource links provided by NLM:


Further study details as provided by Oy Foodfiles Ltd:

Primary Outcome Measures:
  • cholesterol absorption efficiency

Secondary Outcome Measures:
  • changes in blood lipids

Estimated Enrollment: 60
Study Start Date: March 2007
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   25 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441857

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

No publications provided

ClinicalTrials.gov Identifier: NCT00441857     History of Changes
Other Study ID Numbers: DOSE
Study First Received: February 28, 2007
Last Updated: July 4, 2007
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014