Status:
COMPLETED
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Utah State University
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypercholesterolemia
Coronary Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 g...
Detailed Description
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00863265
Start Date
June 1 2009
End Date
February 1 2010
Last Update
June 1 2018
Active Locations (1)
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1
Center for Advance Nutrition at Utah State University
Logan, Utah, United States, 84322-4715