Addition of Phytosterols to a Low Phytosterol Diet

Study Overview
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Brief Summary
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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.

Official Title
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Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet

Conditions
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Hypercholesterolemia, Coronary Heart Disease

Intervention / Treatment
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* Dietary Supplement: Different amount of phytosterols are added into diets


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medium Phytosterols<br>Diets with daily 400 mg of phytosterols | Dietary Supplement: Different amount of phytosterols are added into diets<br>* Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.<br>|
| Experimental: High Phytosterols Diet<br>Diet with 2000 mg of daily phytosterols | Dietary Supplement: Different amount of phytosterols are added into diets<br>* Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.<br>|
| Placebo Comparator: Low Phyto Diet<br>Diet with less than 100 mg of daily phytosterols | Dietary Supplement: Different amount of phytosterols are added into diets<br>* Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal cholesterol excretion |  | At the end of week 4 on each diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal cholesterol absorption |  | At the end of week 4 on each diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phytosterols, cholesterol excretion, cholesterol absorption, diet, mass spectrometry, deuterium