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Addition of Phytosterols to a Low Phytosterol Diet (phyteaux-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00860054
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : April 19, 2012
Sponsor:
Collaborator:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Richard E. Ostlund Jr., MD, Washington University School of Medicine

Brief Summary:
Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. This means that the effects of small amounts of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will examine the effects of phytosterols across a range of levels. The information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Coronary Heart Disease Dietary Supplement: Different amount of phytosterols are added into diets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet
Study Start Date : March 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medium Phytosterols
Diets with daily 400 mg of phytosterols
Dietary Supplement: Different amount of phytosterols are added into diets
Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

Experimental: High Phytosterols Diet
Diet with 2000 mg of daily phytosterols
Dietary Supplement: Different amount of phytosterols are added into diets
Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

Placebo Comparator: Low Phyto Diet
Diet with less than 100 mg of daily phytosterols
Dietary Supplement: Different amount of phytosterols are added into diets
Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.




Primary Outcome Measures :
  1. Fecal cholesterol excretion [ Time Frame: At the end of week 4 on each diet ]

Secondary Outcome Measures :
  1. intestinal cholesterol absorption [ Time Frame: At the end of week 4 on each diet ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Men and women are eligible who:

  • are of any race or ethnicity between 18 to 80 years of age;
  • are in generally good health;
  • have moderately elevated blood cholesterol(LDL cholesterol between 100 and 189 mg/dl)
  • will eat only the foods that are provided by the center during the diet periods;
  • will drink no more than 5 cups of caffeine-containing beverages a day;
  • will consume no more than 1 alcoholic drink a day;
  • will abstain from the consumption of alcohol for 48-hours prior to blood draw days

Exclusion Criteria:

  • are younger than 18 or older than 80 years;
  • have very high cholesterol(LDL cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl);
  • have very high blood pressure(equal to or above 160 mm Hg systolic or 95 mm Hg diastolic);
  • are overweight( BMI greater than 35 kg/m2)
  • are taking lipid-lowering, or any other medication known to affect blood cholesterol;
  • have diabetes mellitus, cancer, heart, liver and/or kidney disease, or chronic disease that might interfere with participation;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860054


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Washington University School of Medicine
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Richard Ostlund, MD Washington University School of Medicine
Publications of Results:
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Responsible Party: Richard E. Ostlund Jr., MD, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00860054    
Other Study ID Numbers: PBRC25025
R01HL050420 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012
Keywords provided by Richard E. Ostlund Jr., MD, Washington University School of Medicine:
phytosterols
cholesterol excretion
cholesterol absorption
diet
mass spectrometry
deuterium
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases