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NCT00166088 · ClinicalTrials.gov registry record · Phase 2
Effect of a Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and Endothelial Progenitor Cells (EPC's)
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00166088: Completed Phase 2 study, sponsored by Emory University.
NCT00166088 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00166088, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Problem of Interest: A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries, and increases the risk of heart disease. The American Heart Association recommendations to follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten can improve blood levels of cholesterol but can lead to a high intake of sugars (especially processed sugars) that can lead to obesity and continued heart problems. Studies of people who eat a diet that is typical of the Mediterranean region have shown that this type of diet leads to reductions in heart disease as well as forms of cancer. A typical Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals, beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is also used in low to moderate amounts with meals. No isolated aspect of the diet explains all of its benefits, but it is believed that the ingredient of the diet that most helps to reduce the risk of heart disease is the high amount of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and certain oils. Several studies of patients with either known heart disease or risk factors for heart disease have shown a reduction in heart disease events, such as heart attacks, as well as markers of heart disease risk when patients followed a Mediterranean diet. Other studies have shown that giving a supplement that contains omega-3 fatty acids to patients with heart disease or risk factors for heart disease also reduces heart disease events and markers of heart disease risk. In this current study we, the investigators at Emory University, plan to compare the effe
Interventions
- DIETARY_SUPPLEMENT Mediterranean Diet
- DIETARY_SUPPLEMENT Mediterranean Dietary Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-12 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
What the finished NCT00166088 record still lists
NCT00166088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Mediterranean Diet is the first listed.
NCT00166088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00166088 about?
NCT00166088 is a clinical study titled "Effect of a Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and Endothelial Progenitor Cells (EPC's)". Problem of Interest: A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries, and increases the risk of heart disease. The American Heart Association recommendations to foll...
What is the current status of trial NCT00166088?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2004-12. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00166088?
The interventions under investigation include: Mediterranean Diet (DIETARY_SUPPLEMENT), Mediterranean Dietary Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00166088?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00166088's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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