Addition of Phytosterols to a Low Phytosterol Diet - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Pennington Biomedical Research Center
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00860054

Purpose

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	Intervention
Hypercholesterolemia Coronary Heart Disease	Dietary Supplement: Different amount of phytosterols are added into diets

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diets Heart Diseases

Drug Information available for: Cholest-5-en-3-ol (3beta)- beta-Sitosterol Campesterol

U.S. FDA Resources

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: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Fecal cholesterol excretion [ Time Frame: At the end of week 4 on each diet ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

intestinal cholesterol absorption [ Time Frame: At the end of week 4 on each diet ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	March 2006
Study Completion Date:	October 2008
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Medium Phytosterols: Experimental 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.
High Phytosterols Diet: Experimental 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.
Low Phyto Diet: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860054

Locations

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

Principal Investigator:

Richard Ostlund, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Richard Ostlund/Professor of Medicine )
Study ID Numbers:	PBRC25025, R01 HL50420
Study First Received:	March 10, 2009
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00860054 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

phytosterols
cholesterol excretion
cholesterol absorption

diet
mass spectrometry
deuterium

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Arteriosclerosis
Coronary Disease
Metabolic Disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis

Coronary Disease
Cardiovascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009