Phytosterol Supplementation and Cardiovascular Risk

Not Applicable

Completed

• Conditions: Hypercholesteremia

• Registration Number: NCT00153738
• Lead Sponsor: The Cooper Institute

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.

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.

Study Timeline

• Study Start: 2004-03
• Study Completion: 2005-08
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ingestion of the supplement will result in reduced LDL cholesterol.

Trial Locations

Locations (1)

The Cooper Institute; 🇺🇸 Dallas, Texas, United States