Phytosterol Supplementation and Cardiovascular Risk

The Cooper Institute

Status: Completed

Conditions: Hypercholesteremia

Treatments: Drug: phytosterol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00153738

CI0129

Details and patient eligibility

About

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 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.

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind