Status:

COMPLETED

Addition of Phytosterols to a Low Phytosterol Diet

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

Pennington Biomedical Research Center

Conditions:

Hypercholesterolemia

Coronary Heart Disease

Eligibility:

All Genders

18-80 years

Phase:

NA

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 prod...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00860054

Start Date

March 1 2006

End Date

October 1 2008

Last Update

April 19 2012

Active Locations (1)

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808