Addition of Phytosterols to a Low Phytosterol Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-10-31

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.

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Detailed Description

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Conditions

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Hypercholesterolemia Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Medium Phytosterols

Diets with daily 400 mg of phytosterols

Group Type EXPERIMENTAL

Different amount of phytosterols are added into diets

Intervention Type DIETARY_SUPPLEMENT

Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

High Phytosterols Diet

Diet with 2000 mg of daily phytosterols

Group Type EXPERIMENTAL

Different amount of phytosterols are added into diets

Intervention Type DIETARY_SUPPLEMENT

Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

Low Phyto Diet

Diet with less than 100 mg of daily phytosterols

Group Type PLACEBO_COMPARATOR

Different amount of phytosterols are added into diets

Intervention Type DIETARY_SUPPLEMENT

Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

Interventions

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Different amount of phytosterols are added into diets

Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

Intervention Type DIETARY_SUPPLEMENT

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes