Clinical trial NCT00860054: Addition of Phytosterols to a Low Phytosterol Diet
Official title: Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Coronary Heart Disease
Keywords: phytosterols
cholesterol excretion
cholesterol absorption
diet
mass spectrometry
deuterium
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
First posted: 2009-03-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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;

Primary outcomes:
measure: Fecal cholesterol excretion
timeFrame: At the end of week 4 on each diet
Secondary outcomes:
measure: intestinal cholesterol absorption
timeFrame: At the end of week 4 on each diet
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Washington University School of Medicine
name: Richard Ostlund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Racette SB, Lin X, Lefevre M, Spearie CA, Most MM, Ma L, Ostlund RE Jr. Dose effects of dietary phytosterols on cholesterol metabolism: a controlled feeding study. Am J Clin Nutr. 2010 Jan;91(1):32-8. doi: 10.3945/ajcn.2009.28070. Epub 2009 Nov 4.