Addition of Phytosterols to a Low Phytosterol Diet
Overview
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.
Full Title of Study: “Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 2006
Interventions
- Dietary Supplement: 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.
Arms, Groups and Cohorts
- Experimental: Medium Phytosterols
- Diets with daily 400 mg of phytosterols
- Experimental: High Phytosterols Diet
- Diet with 2000 mg of daily phytosterols
- Placebo Comparator: Low Phyto Diet
- Diet with less than 100 mg of daily phytosterols
Clinical Trial Outcome Measures
Primary Measures
- Fecal cholesterol excretion
- Time Frame: At the end of week 4 on each diet
Secondary Measures
- intestinal cholesterol absorption
- Time Frame: At the end of week 4 on each diet
Participating in This Clinical Trial
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;
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Washington University School of Medicine
- Collaborator
- Pennington Biomedical Research Center
- Provider of Information About this Clinical Study
- Principal Investigator: Richard E. Ostlund Jr., MD, Professor of Medicine – Washington University School of Medicine
- Overall Official(s)
- Richard Ostlund, MD, Principal Investigator, Washington University School of Medicine
Citations Reporting on Results
Racette SB, Lin X, Lefevre M, Spearie CA, Most MM, Ma L, Ostlund RE Jr. Dose effects of dietary phytosterols on cholesterol metabolism: a controlled feeding study. Am J Clin Nutr. 2010 Jan;91(1):32-8. doi: 10.3945/ajcn.2009.28070. Epub 2009 Nov 4.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.