search
Back to results

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

Primary Purpose

Hypercholesterolemia, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Phytosterol and High Phytosterol Diets
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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

Sites / Locations

  • Pennington Biomedical Research Center-Louisana State University System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Low Phytosterol Diet

High Phytosterol Diet

Arm Description

Diet with 100 mg of daily phytosterols

Diet with 600 mg of daily phytosterols

Outcomes

Primary Outcome Measures

Fecal cholesterol excretion

Secondary Outcome Measures

Intestinal cholesterol absorption

Full Information

First Posted
March 11, 2009
Last Updated
May 2, 2012
Sponsor
Washington University School of Medicine
Collaborators
Pennington Biomedical Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00860509
Brief Title
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism
Acronym
Phyteaux-II
Official Title
Phyteaux-II- Regulation of Cholesterol Absorption: Response of LDL to Low and Naturally High Phytosterol Diets
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine
Collaborators
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Phytosterol Diet
Arm Type
Placebo Comparator
Arm Description
Diet with 100 mg of daily phytosterols
Arm Title
High Phytosterol Diet
Arm Type
Active Comparator
Arm Description
Diet with 600 mg of daily phytosterols
Intervention Type
Other
Intervention Name(s)
Low Phytosterol and High Phytosterol Diets
Intervention Description
Diets with 600 or 100 mg of daily phytosterols 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
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Ostlund, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center-Louisana State University System
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20808333
Citation
Lin X, Racette SB, Lefevre M, Spearie CA, Most M, Ma L, Ostlund RE Jr. The effects of phytosterols present in natural food matrices on cholesterol metabolism and LDL-cholesterol: a controlled feeding trial. Eur J Clin Nutr. 2010 Dec;64(12):1481-7. doi: 10.1038/ejcn.2010.180. Epub 2010 Sep 1.
Results Reference
result

Learn more about this trial

Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism

We'll reach out to this number within 24 hrs