Addition of Phytosterols to a Low Phytosterol Diet

Completed · Not applicable

Conditions studied: Hypercholesterolemia, Coronary Heart Disease

In brief

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.

Key facts

Study ID

NCT00860054

Run by

Washington University School of Medicine

People needed

18

Starts

2006-03-01

Expected to finish

2008-10-01

Last updated by the study team

2012-04-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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