Addition of Phytosterols to a Low Phytosterol Diet

NCT00860054 | Completed

• 2 other identifiers: PBRC25025R01HL050420
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Coronary Heart Disease

Keywords

phytosterols; cholesterol excretion; cholesterol absorption; diet; mass spectrometry; deuterium

Outcome Measures

Primary Outcomes (1)

• Fecal cholesterol excretion

  At the end of week 4 on each diet

Secondary Outcomes (1)

• intestinal cholesterol absorption

  At the end of week 4 on each diet

Study Arms (3)

Medium Phytosterols

EXPERIMENTAL

Diets with daily 400 mg of phytosterols

Dietary Supplement: Different amount of phytosterols are added into diets

High Phytosterols Diet

EXPERIMENTAL

Diet with 2000 mg of daily phytosterols

Dietary Supplement: Different amount of phytosterols are added into diets

Low Phyto Diet

PLACEBO COMPARATOR

Diet with less than 100 mg of daily phytosterols

Dietary Supplement: Different amount of phytosterols are added into diets

Interventions

Different amount of phytosterols are added into diets DIETARY_SUPPLEMENT

Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.

High Phytosterols Diet; Low Phyto Diet; Medium Phytosterols

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related 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.

  PMID: 19889819 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Richard Ostlund, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2008
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

US (1)