NCT00153738

Brief Summary

This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

First QC Date

September 7, 2005

Last Update Submit

March 12, 2014

Conditions

Hypercholesteremia

Keywords

LDL-C, phytosterol

Outcome Measures

Primary Outcomes (1)

  • Ingestion of the supplement will result in reduced LDL cholesterol.

Interventions

phytosterolDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits

You may not qualify if:

  • BMI \<18.5 or \>34.9, recent blood donation, serious or life-threatening disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cooper Institute

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Officials

  • Conrad Earnest, PhD

    The Cooper Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

March 1, 2004

Study Completion

August 1, 2005

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)