NCT01102647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 7, 2010

Last Update Submit

April 28, 2011

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Decrease in plasma LDL-cholesterol

    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.

    29 days

Secondary Outcomes (1)

  • Increase plasma plant sterols

    29 days

Study Arms (1)

Phytosterol ester

EXPERIMENTAL

Plant sterol compared with placebo

Dietary Supplement: phytosterol ester

Interventions

phytosterol esterDIETARY_SUPPLEMENT

1.6 g phytosterols/day for 29 days

Also known as: Phytocell Phytosterols, NPN#: 80012048
Phytosterol ester

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • heterozygous for phytosterolemia, wild-type.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22378727DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Peter J Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 13, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

CA(1)