Phytosterols, Ezetimibe, and Cholesterol Metabolism
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Hypercholesterolemia, Coronary Heart Disease
In brief
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.
Key facts
- Study ID
- NCT00863265
- Run by
- Washington University School of Medicine
- People needed
- 22
- Starts
- 2009-06-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2018-06-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Center for Advance Nutrition at Utah State University — Logan, Utah, United States
Full record on ClinicalTrials.gov
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