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
  Purpose

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


Condition Intervention Phase
Cardiovascular Disease
Dietary Supplement: phytosterol ester
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 26
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

  • Pregnant,
  • Previous heart attack,
  • Kidney disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102647

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

No publications provided by University of Manitoba

Additional 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
Study First Received: April 7, 2010
Last Updated: April 28, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014