Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism (Phyteaux-II)

Phyteaux-II- Regulation of Cholesterol Absorption: Response of LDL to Low and Naturally High Phytosterol Diets

The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25 healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL cholesterol and cholesterol excretion will be improved on the high phytosterol diet even though macronutrient composition, mineral intake and fiber consumption are similar.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center-Louisana State University System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of any race or ethnicity between 18 to 80 years of age, inclusive;
  • Body mass index between 20-35 kg/m2;
  • LDL-cholesterol between 100-189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;
  • Free of chronic disease;
  • Willing to eat only the foods that are provided by the Center during the diet periods;
  • Willing to consume no more than 1 alcoholic drink per day.
  • Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;
  • Willing to drink no more than 5 cups of caffeine-containing beverages a day.

Exclusion Criteria:

  • Age < 18 or > 80 years;
  • Based on duplicate screening laboratory values: 1) LDL-C > or = 190 mg/dL; 2) TG > or = 250 mg/dL; 3) blood pressure > or = 160 mm Hg systolic or 95 mm Hg diastolic;
  • Documented presence of atherosclerotic disease;
  • Diabetes mellitus;
  • Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;
  • Body mass index > 35;
  • For women, pregnancy, breast feeding or postpartum < 6 months;
  • For women, peri-menopausal;
  • History of drug or alcohol abuse;
  • History of depression or mental illness requiring treatment or medication within the last 6 months;
  • Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
  • Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;
  • Lifestyle or schedule incompatible with the study protocol;
  • Planned continued use of dietary supplements through the study trial;
  • Taking any lipid-lowering, or other medications known to affect blood cholesterol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Low Phytosterol Diet
Diet with 100 mg of daily phytosterols
Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order
Active Comparator: High Phytosterol Diet
Diet with 600 mg of daily phytosterols
Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal cholesterol excretion
Time Frame: At the end of week 4 on each diet
At the end of week 4 on each diet

Secondary Outcome Measures

Outcome Measure
Time Frame
Intestinal cholesterol absorption
Time Frame: At the end of week 4 on each diet
At the end of week 4 on each diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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