Cholesterol Metabolism in Heterozygous Phytosterolemia

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01102647
First received: April 7, 2010
Last updated: April 28, 2011
Last verified: April 2011

April 7, 2010
April 28, 2011
April 2010
April 2011   (final data collection date for primary outcome measure)
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.
Decrease in plasma LDL-cholesterol [ Time Frame: 28 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.
Complete list of historical versions of study NCT01102647 on ClinicalTrials.gov Archive Site
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
Increase plasma plant sterols [ Time Frame: 28 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
Not Provided
Not Provided
 
Cholesterol Metabolism in Heterozygous Phytosterolemia
Assessment of 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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Cardiovascular Disease
Dietary Supplement: phytosterol ester
1.6 g phytosterols/day for 29 days
Other Name: Phytocell Phytosterols, NPN#: 80012048
Experimental: Phytosterol ester
Plant sterol compared with placebo
Intervention: Dietary Supplement: phytosterol ester
Myrie SB, Mymin D, Triggs-Raine B, Jones PJ. Serum lipids, plant sterols, and cholesterol kinetic responses to plant sterol supplementation in phytosterolemia heterozygotes and control individuals. Am J Clin Nutr. 2012 Apr;95(4):837-44. doi: 10.3945/ajcn.111.028985. Epub 2012 Feb 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

  • Pregnant,
  • Previous heart attack,
  • Kidney disease.
Both
16 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01102647
B2009:133
Yes
Peter J Jones, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Peter J Jones, PhD University of Manitoba
University of Manitoba
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP