Cholesterol Metabolism in Heterozygous Phytosterolemia

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: phytosterol ester

• Registration Number: NCT01102647
• Lead Sponsor: University of Manitoba

Brief 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• heterozygous for phytosterolemia, wild-type.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phytosterol ester	phytosterol ester	Plant sterol compared with placebo

Primary Outcome Measures

Name	Time	Method
Decrease in plasma LDL-cholesterol	29 days	Other studies have found 10% reduction in plasma LDL-cholesterol after 2.2-3.2 gram of plant sterol supplementation for 4 weeks in heterozygous phytosterolemia.

Secondary Outcome Measures

Name	Time	Method
Increase plasma plant sterols	29 days	We will use a control group and compare the level of increase in plasma plant sterol levels in both group over the course of plant sterol consumption

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada