Phytosterol Supplementation and Cardiovascular Risk

Hypercholesteremia Clinical Trial

Official title:

Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153738
• Other study ID #: CI0129
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: March 12, 2014
• Start date: March 2004
• Est. completion date: August 2005

Study information

• Verified date: March 2014
• Source: The Cooper Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Drug:
• phytosterol

Locations

Country	Name	City	State
United States	The Cooper Institute	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Cooper Institute	Cargill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ingestion of the supplement will result in reduced LDL cholesterol.