Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism

Inclusion criteria

• Male or female of any race or ethnicity between 18 to 80 years of age, inclusive;
• Body mass index between 20-35 kg/m2;
• LDL-cholesterol between 100-189 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 consume no more than 1 alcoholic drink per day.
• 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 > or = 190 mg/dL; 2) TG > or = 250 mg/dL; 3) blood pressure > or = 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;
• 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