Cholesterol Metabolism in Heterozygous Phytosterolemia

University of Manitoba

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: phytosterol ester

Study type: Interventional

Funder types: Other

Identifiers

NCT01102647

B2009:133

Details and patient eligibility

About

The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.

Full description

A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.

Enrollment: 26 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• heterozygous for phytosterolemia, wild-type.

Exclusion criteria

• Pregnant,
• Previous heart attack,
• Kidney disease.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 1 patient group

Phytosterol ester

Experimental group

Description:

Plant sterol compared with placebo

Treatment:

Dietary Supplement: phytosterol ester