Phytosterol Supplementation and Cardiovascular Risk - Full Text View

Sponsors and Collaborators:	The Cooper Institute Cargill
Information provided by:	The Cooper Institute
ClinicalTrials.gov Identifier:	NCT00153738

Purpose

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.

Condition	Intervention
Hypercholesteremia	Drug: phytosterol

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Further study details as provided by The Cooper Institute:

Primary Outcome Measures:

Ingestion of the supplement will result in reduced LDL cholesterol.

Estimated Enrollment:	72
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2005

Detailed Description:

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.

The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153738

Locations

United States, Texas
The Cooper Institute
Dallas, Texas, United States, 75230

Sponsors and Collaborators

The Cooper Institute

Cargill

Investigators

Principal Investigator:

Conrad Earnest, PhD

The Cooper Institute

More Information

Study ID Numbers:	CI0129
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00153738
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cooper Institute:

LDL-C, phytosterol

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009