Phytosterols, Ezetimibe, and Cholesterol Metabolism

The investigators will perform a randomized, placebo-controlled crossover feeding study in 25
subjects with greater than ideal levels of LDL cholesterol who do not require
anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding
center that is deficient in phytosterols for three periods of 21 days separated by 7-day
washout periods. Treatments will be given in random order During period B placebo
phytosterols and placebo ezetimibe will be given; during period C placebo phytosterols and
active ezetimibe will be given; during period A active phytosterols and active ezetimibe will
be given. Study endpoints are fecal cholesterol excretion and percent cholesterol absorption
determined by gas chromatography/mass spectrometry and circulating LDL cholesterol.

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.