Cholesterol Metabolism in Heterozygous Phytosterolemia

Cardiovascular Disease Clinical Trial

Official title:

Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102647
• Other study ID #: B2009:133
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2010
• Last updated: April 28, 2011
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

• Pregnant,

• Previous heart attack,

• Kidney disease.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• phytosterol ester
1.6 g phytosterols/day for 29 days

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in plasma LDL-cholesterol	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.	29 days	No
Secondary	Increase plasma plant sterols	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	29 days	No