Addition of Phytosterols to a Low Phytosterol Diet

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Coronary Heart Disease
• Interventions: Dietary Supplement: Different amount of phytosterols are added into diets

• Registration Number: NCT00860054
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-09
• Study Completion: 2008-10
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medium Phytosterols	Different amount of phytosterols are added into diets	Diets with daily 400 mg of phytosterols
High Phytosterols Diet	Different amount of phytosterols are added into diets	Diet with 2000 mg of daily phytosterols
Low Phyto Diet	Different amount of phytosterols are added into diets	Diet with less than 100 mg of daily phytosterols

Primary Outcome Measures

Name	Time	Method
Fecal cholesterol excretion	At the end of week 4 on each diet

Secondary Outcome Measures

Name	Time	Method
intestinal cholesterol absorption	At the end of week 4 on each diet

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States