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Completed

NCT Number: NCT01102647

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • heterozygous for phytosterolemia, wild-type.

Exclusion criteria

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

Treatment and study plan

phytosterol ester

Dietary Supplement

1.6 g phytosterols/day for 29 days

Other names: Phytocell Phytosterols, NPN#: 80012048

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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