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

The Washington University

Status: Completed

Conditions: Coronary Heart Disease; Hypercholesterolemia

Treatments: Dietary Supplement: Different amount of phytosterols are added into diets

Study type: Interventional

Funder types: Other

Identifiers

NCT00860054

R01HL050420 (U.S. NIH Grant/Contract)

PBRC25025

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups, including a placebo group

Medium Phytosterols

Experimental group

Description:

Diets with daily 400 mg of phytosterols

Treatment:

Dietary Supplement: Different amount of phytosterols are added into diets

High Phytosterols Diet

Experimental group

Description:

Diet with 2000 mg of daily phytosterols

Treatment:

Dietary Supplement: Different amount of phytosterols are added into diets

Low Phyto Diet

Placebo Comparator group

Description:

Diet with less than 100 mg of daily phytosterols

Treatment:

Dietary Supplement: Different amount of phytosterols are added into diets