Addition of Phytosterols to a Low Phytosterol Diet

Hypercholesterolemia Clinical Trial

— phyteaux-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860054
• Other study ID #: PBRC25025
• Secondary ID: R01HL050420
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: April 17, 2012
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal cholesterol excretion		At the end of week 4 on each diet	No
Secondary	intestinal cholesterol absorption		At the end of week 4 on each diet	No