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Completed

NCT Number: NCT00441857

Effect of Plant Stanols on Cholesterol Absorption

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oy Foodfiles Ltd

Kuopio, 70210, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plant stanol consumption

Behavioral

Primary outcomes

  1. cholesterol absorption efficiency

Secondary outcomes

  1. changes in blood lipids

Sponsors and collaborators

Lead sponsor

Oy Foodfiles Ltd

Other

Registry information

Official study title

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

Acronym: DOSE

Important dates

Study start
2007
Study completion
2007
First posted
Mar 1, 2007
Registry last updated
Jul 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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