Cholesterol Metabolism in Heterozygous Phytosterolemia

NCT ID: NCT01102647

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Phytosterol ester

Plant sterol compared with placebo

Group Type EXPERIMENTAL

phytosterol ester

Intervention Type DIETARY_SUPPLEMENT

1.6 g phytosterols/day for 29 days

Interventions

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phytosterol ester

1.6 g phytosterols/day for 29 days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Phytocell Phytosterols, NPN#: 80012048

Eligibility Criteria

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Inclusion Criteria

* heterozygous for phytosterolemia, wild-type.

Exclusion Criteria

* Pregnant,
* Previous heart attack,
* Kidney disease.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Principal Investigators

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Peter J Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 22378727 (View on PubMed)

Other Identifiers

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B2009:133

Identifier Type: -

Identifier Source: org_study_id

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