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Sponsors and Collaborators: |
Washington University School of Medicine Utah State University |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00863265 |
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 |
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Hypercholesterolemia Coronary Heart Disease |
Drug: Phytosterol-Deficient Diet, Ezetimibe 10 mg, Phytosterol Esters Containing 2000 mg Phytosterols |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
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 |
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Phytosterol-Deficient Diet: Placebo Comparator
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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Diet Plus Ezetimibe: Active Comparator
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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Diet Plus Ezetimibe plus Phytosterols: Active Comparator
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.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Logan, Utah, United States, 84322-4715 |
Principal Investigator: | Richard Ostlund, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Richard Ostlund/Professor of Medicine ) |
Study ID Numbers: | CANUSU-phyto3, R01 HL50420 |
Study First Received: | March 16, 2009 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00863265 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Phytosterols Ezetimibe Cholesterol Excretion Cholesterol Absorption |
Diet Mass Spectrometry Deuterium |
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Phytosterol Antilipemic Agents Myocardial Ischemia Vascular Diseases Ezetimibe |
Anticholesteremic Agents Ischemia Arteriosclerosis Coronary Disease Metabolic Disorder Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Myocardial Ischemia Vascular Diseases Ezetimibe |
Anticholesteremic Agents Arteriosclerosis Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |