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| Sponsor: | Washington University School of Medicine |
|---|---|
| Collaborator: |
Utah State University |
| Information provided by: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00863265 |
Purpose
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 nearly completely. 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 in random order. During period I placebo phytosterols and placebo ezetimibe will be given; during period II placebo phytosterols and active ezetimibe will be given; during period III active phytosterols and active ezetimibe will be given. Study endpoints are fecal cholesterol excretion and percent cholesterol absorption determined by gas chromatography/mass spectrometry, circulating phytosterol levels and circulating LDL cholesterol levels.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia Coronary Heart Disease |
Drug: Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Regulation of Cholesterol Absorption: LDL Cholesterol Response to a Combination of Phytosterols and Ezetimibe (Phyto-3) |
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Phytosterol-Deficient Diet
Phytosterol-deficient diet plus ezetimibe placebo plus phytosterol placebo.
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Drug: Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols
Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
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Active Comparator: Diet Plus Ezetimibe
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus phytosterol placebo.
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Drug: Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols
Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
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Active Comparator: Diet Plus Ezetimibe plus Phytosterols
Phytosterol-deficient diet plus 10 mg/day of ezetimibe plus 2000 mg/day of phytosterols.
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Drug: Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols
Subjects will undergo three diet periods of 21 days each. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. Subjects will also receive either no active treatment, ezetimibe, or ezetimibe plus phytosterols.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Richard Ostlund, M.D. | 314-362-7617 | rostlund@dom.wustl.edu |
| Contact: Xiaobo Lin, Ph.D. | 314-362-8287 | xlin@dom.wustl.edu |
| United States, Utah | |
| Center for Advance Nutrition at Utah State University | Not yet recruiting |
| Logan, Utah, United States, 84322-4715 | |
| Contact: Michael Lefevre, Ph.D. 435-797-3821 michael.lefevre@usu.edu | |
| Contact: David York, Ph.D. (435) 797-2578 david.york@usu.edu | |
| Principal Investigator: | Richard Ostlund, M.D. | Washington University School of Medicine |
More Information
| Responsible Party: | Richard Ostlund/Professor of Medicine, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00863265 History of Changes |
| Other Study ID Numbers: | CANUSU-phyto3, R01 HL50420 |
| Study First Received: | March 16, 2009 |
| Last Updated: | March 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Phytosterols Ezetimibe Cholesterol Excretion Cholesterol Absorption |
Diet Mass Spectrometry Deuterium |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypercholesterolemia Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |