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Effect of Plant Stanols on Cholesterol Absorption (DOSE)

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Oy Foodfiles

Status and phase

Completed
Phase 4

Conditions

Hypercholesterolemia

Treatments

Behavioral: plant stanol consumption

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

25 to 68 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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