- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860509
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism (Phyteaux-II)
May 2, 2012 updated by: Washington University School of Medicine
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC26030
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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