Phytosterol Supplementation and Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
Cargill
Information provided by:
The Cooper Institute
ClinicalTrials.gov Identifier:
NCT00153738
First received: September 7, 2005
Last updated: March 12, 2014
Last verified: March 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00153738     History of Changes
Other Study ID Numbers: CI0129
Study First Received: September 7, 2005
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cooper Institute:
LDL-C, phytosterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014