Addition of Phytosterols to a Low Phytosterol Diet

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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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Different amount of phytosterols are added into diets

Dietary Supplement

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

Primary outcomes

Fecal cholesterol excretion

Time frame: At the end of week 4 on each diet

Secondary outcomes

intestinal cholesterol absorption

Time frame: At the end of week 4 on each diet

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Pennington Biomedical Research Center

Registry information

Official study title

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

Acronym: phyteaux-I

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2008
First posted: Mar 11, 2009
Registry last updated: Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed