Back to results

Addition of Phytosterols to a Low Phytosterol Diet (phyteaux-I)

Primary Purpose

Hypercholesterolemia, Coronary Heart Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Different amount of phytosterols are added into diets

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring phytosterols, cholesterol excretion, cholesterol absorption, diet, mass spectrometry, deuterium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Medium Phytosterols

High Phytosterols Diet

Low Phyto Diet

Arm Description

Diets with daily 400 mg of phytosterols

Diet with 2000 mg of daily phytosterols

Diet with less than 100 mg of daily phytosterols

Outcomes

Primary Outcome Measures

Fecal cholesterol excretion

Secondary Outcome Measures

intestinal cholesterol absorption

Full Information

NCT ID

NCT00860054

First Posted

March 10, 2009

Last Updated

April 17, 2012

Sponsor

Washington University School of Medicine

Collaborators

Pennington Biomedical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00860054

Brief Title

Addition of Phytosterols to a Low Phytosterol Diet

Acronym

phyteaux-I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Coronary Heart Disease

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medium Phytosterols

Arm Type

Experimental

Arm Description

Diets with daily 400 mg of phytosterols

Arm Title

High Phytosterols Diet

Arm Type

Experimental

Arm Description

Diet with 2000 mg of daily phytosterols

Arm Title

Low Phyto Diet

Arm Type

Placebo Comparator

Arm Description

Diet with less than 100 mg of daily phytosterols

Intervention Type

Dietary Supplement

Intervention Name(s)

Different amount of phytosterols are added into diets

Intervention Description

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

Primary Outcome Measure Information:

Title

Fecal cholesterol excretion

Time Frame

At the end of week 4 on each diet

Secondary Outcome Measure Information:

Title

intestinal cholesterol absorption

Time Frame

At the end of week 4 on each diet

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Ostlund, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19889819

Citation

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.

Results Reference

result

Learn more about this trial

Addition of Phytosterols to a Low Phytosterol Diet

We'll reach out to this number within 24 hrs