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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014