Phytosterol Supplementation and Cardiovascular Risk

Overview

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.

Full Title of Study: “Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Prevention
  • Masking: Single

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.

Interventions

• Drug: phytosterol

Clinical Trial Outcome Measures

Primary Measures

• Ingestion of the supplement will result in reduced LDL cholesterol.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • The Cooper Institute
• Collaborator
  • Cargill
• Overall Official(s)
  • Conrad Earnest, PhD, Principal Investigator, The Cooper Institute