Status:
COMPLETED
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Pennington Biomedical Research Center
Conditions:
Hypercholesterolemia
Coronary Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyze...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00860509
Start Date
November 1 2006
End Date
March 1 2007
Last Update
May 3 2012
Active Locations (1)
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1
Pennington Biomedical Research Center-Louisana State University System
Baton Rouge, Louisiana, United States, 70808