Cholesterol Metabolism in Heterozygous Phytosterolemia
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia|
- Decrease in plasma LDL-cholesterol [ Time Frame: 29 days ] [ Designated as safety issue: No ]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.
- Increase plasma plant sterols [ Time Frame: 29 days ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Phytosterol ester
Plant sterol compared with placebo
Dietary Supplement: phytosterol ester
1.6 g phytosterols/day for 29 days
Other Name: Phytocell Phytosterols, NPN#: 80012048
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102647
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3T 2N2|
|Principal Investigator:||Peter J Jones, PhD||University of Manitoba|