Phytosterols, Ezetimibe, and Cholesterol Metabolism

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover trial the effects of placebo, ezetimibe treatment and ezetimibe plus phytosterol treatment will be measured.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Utah State University
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• Male or female of any race or ethnicity between 18 to 80 years of age;

• Body mass index between 20 - 35 kg/m2;

• LDL-cholesterol between 130 - 189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;

• Free of chronic disease;

• Willing to eat only the foods that are provided by the Center during the diet periods;

• Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;

• Willing to drink no more than 5 cups of caffeine-containing beverages a day.

Exclusion Criteria:

• Age < 18 or > 80 years;

• Based on duplicate screening laboratory values: 1)LDL-C >=190 mg/dL; 2)TG >=250 mg/dL;3)blood pressure >= 160 mm Hg systolic or 95 mm Hg diastolic;

• Documented presence of atherosclerotic disease;

• Diabetes mellitus;

• Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;

• Body mass index > 35;

• For women, pregnancy, breast feeding or postpartum < 6 months;

• For women, peri-menopausal;

• For women, sexually active but not practicing effective birth control methods;

• History of drug or alcohol abuse;

• History of depression or mental illness requiring treatment or medication within the last 6 months;

• multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;

• Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;

• Lifestyle or schedule incompatible with the study protocol;

• Planned continued use of dietary supplements through the study trial;

• Taking any lipid-lowering, or other medications known to affect blood cholesterol.