NCT01102647

Cholesterol Metabolism in Heterozygous Phytosterolemia

Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	phytosterol ester	1.6 g phytosterols/day for 29 days

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-04-13
• Last updated: 2011-05-02

Locations

1 site across 1 country: Canada