Coronary Heart Disease, Hypercholesterolemia
Conditions
Keywords
phytosterols, cholesterol excretion, cholesterol absorption, diet, mass spectrometry, deuterium
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 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.
Interventions
DIETARY_SUPPLEMENTDifferent 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.
Sponsors
Pennington Biomedical Research Center
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal cholesterol excretion | At the end of week 4 on each diet |
Secondary
| Measure | Time frame |
|---|---|
| intestinal cholesterol absorption | At the end of week 4 on each diet |
Countries
United States
Outcome results
None listed