Early Phase 1
Completed N=22
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Hypercholesterolemia · Coronary Heart Disease
Source: ClinicalTrials.gov NCT00863265 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Cholesterol Excretion — 505; 794; 962 mg per day — p=0.01
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cholesterol Excretion |
505; 794; 962 | 0.01 sig |
| PRIMARY Percent Cholesterol Absorption |
69.0; 46.2; 32.6 | <0.01 sig |
| PRIMARY LDL Cholesterol |
129; 108; 101 | <0.01 sig |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00863265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.