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.

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