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NCT00531128 · ClinicalTrials.gov registry record · NA
The Effect of Dietary Sitosterol on Blood Sugar and Cholesterol
A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT00531128 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 14 participants.
The verdict
NCT00531128, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will determine if dietary supplements of sitosterol (a plant cholesterol commonly found in vegetables) can modify blood sugar and cholesterol levels and reduce the stiffness of the blood vessels in people with an abnormal copy of a gene that causes sitosterolemia. People who carry only one copy of the abnormal gene are healthy but have increased blood levels of sitosterol. People with two abnormal copies of the gene have increased levels of sitosterol and have an increased risk of heart attack. This condition is called sitosterolemia. Although extremely rare in the general population, up to 4% of the Amish carry an abnormal copy of this gene. People of Amish background who are 18 years of age or older and in whom one person carries one copy of the abnormal gene that causes sitosterolemia and the other does not have an abnormal gene may be eligible for this study. Subjects must be of the same sex and within 5 years of age of each other. During two periods of one month each participants receive pills containing sitosterol and then a special diet and meal supplements to change the levels of sitosterol in the diet. During only one of the two study periods, subjects receive sitosterol supplements in the pills for one month and then for 10 days in the diet. At the end of each study period, subjects come to the NIH Clinical Center for one day for the following tests: * Measurements of height, weight, blood pressure and heart rate. * Adipose (fat) tissue biopsy. A small piece of fat from under the skin of the abdomen is removed to examine how sitosterol affects fat tissue and its ability to process sugar and fat. * Indirect calorimetry. A plastic transparent hood is placed over the subject s head to collect the air that is breathed for about one-half hour to study how the body uses sugar to generate energy. * Endothelial vascular function. An ultrasound picture of a blood vessel in the forearm is taken and a blood pressure cuff is inflated around the arm to me
Interventions
- BEHAVIORAL High/Low Sitosterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-09-10 |
| Est. Completion | 2018-05-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00531128
The ClinicalTrials.gov registry entry for NCT00531128 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which High/Low Sitosterol is the first listed.
NCT00531128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00531128 about?
NCT00531128 is a clinical study titled "The Effect of Dietary Sitosterol on Blood Sugar and Cholesterol". This study will determine if dietary supplements of sitosterol (a plant cholesterol commonly found in vegetables) can modify blood sugar and cholesterol levels and reduce the stiffness of the blood vessels in people with an abnormal copy of a gene that causes sitosterolemia. People who carry only on...
What is the current status of trial NCT00531128?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2007-09-10. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT00531128?
The interventions under investigation include: High/Low Sitosterol (BEHAVIORAL).
Who is sponsoring clinical trial NCT00531128?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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