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NCT01038362 · ClinicalTrials.gov registry record · NA
Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease
A NA study of Coronary Artery Disease, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01038362: Completed NA study of Coronary Artery Disease, sponsored by Boston University.
NCT01038362 is a NA study of Coronary Artery Disease that has completed, run by Boston University. The registered enrollment target is 52 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01038362, a NA study of Coronary Artery Disease, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. In patients with atherosclerosis, these functions of the endothelium are impaired and these abnormalities may contribute to the development of heart attack and stroke. Observational studies have shown that frequent nut consumption decreases the risk of cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined. Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable effects on cardiovascular disease. In addition, there is growing evidence that these compounds may improve the function of the endothelium. The present study is designed to test the hypothesis that an almond-enriched diet will improve the function of the endothelium in patients with coronary artery disease. Subjects will be enrolled into a randomized, placebo-controlled, crossover study that will compare a National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the same number of total calories but includes 3 ounces of almonds daily. Participants will consume each diet for six weeks with a four-week rest period between diets. The order of diets will be randomized (almonds or no almonds). Dietary assessments via food recall questionnaires will be employed at the study entry, end of the four week washout period, and end of the second intervention. If subjects are drifting from the recommendations of the STEP 1 diet, counseling will be given to urge compliance. The primary endpoint will be endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study outcomes will include lipid profiles, markers of inflammation and oxidative stress. Enrollment will continue until 40 subjects with complete data are available. Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of Agricult
Conditions Studied
Interventions
- OTHER NCEP Step 1 diet plus Almonds
- OTHER No Almonds
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT01038362 record still lists
NCT01038362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which NCEP Step 1 diet plus Almonds is the first listed.
NCT01038362 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01038362 about?
NCT01038362 is a clinical study titled "Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease". The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. In patients with atherosclerosis, these functions of the endothelium are impaired and these abnormalities may cont...
What is the current status of trial NCT01038362?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2009-04. Estimated completion is 2009-12.
What conditions does trial NCT01038362 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01038362?
The interventions under investigation include: NCEP Step 1 diet plus Almonds (OTHER), No Almonds (OTHER).
Who is sponsoring clinical trial NCT01038362?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01038362 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01038362's enrollment target sits among peer trials
52 177th of 219 higher than 42 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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