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Cholesterol Metabolism in Heterozygous Phytosterolemia

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ClinicalTrials.gov Identifier: NCT01102647
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : May 2, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: phytosterol ester Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia
Study Start Date : April 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Decrease in plasma LDL-cholesterol [ Time Frame: 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 :
  1. Increase plasma plant sterols [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102647

Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Principal Investigator: Peter J Jones, PhD University of Manitoba

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter J Jones, University of Manitoba
ClinicalTrials.gov Identifier: NCT01102647     History of Changes
Other Study ID Numbers: B2009:133
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Cardiovascular Diseases