Phytosterol Supplementation and Cardiovascular Risk

• Sponsor: The Cooper Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00153738
• Collaborator: Cargill (Industry)
• Enrollment: 72
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesteremia	Drug: phytosterol	N/A

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
• Study Start Date: Mar 1, 2004
• Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. Ingestion of the supplement will result in reduced LDL cholesterol. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	The Cooper Institute	Dallas	Texas	United States	75230

Sponsors and Collaborators

• The Cooper Institute
• Cargill

Investigators

• Principal Investigator: Conrad Earnest, PhD, The Cooper Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00153738
• Other Study ID Numbers: CI0129
• First Posted: Sep 12, 2005
• Last Update Posted: Mar 13, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by , ,: LDL-C, phytosterol
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of Mar 13, 2014