Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease
Public ClinicalTrials.gov record NCT01038362. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects Of Almonds On Vascular Reactivity And Biomarkers Of Inflammation, Oxidative Stress And Endothelial Function In Patients With Coronary Artery Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood collection will be performed in the principal investigator's research unit at Boston Medical Center.
Study identification
- NCT ID
- NCT01038362
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2009
- Primary completion
- Nov 30, 2009
- Completion
- Nov 30, 2009
- Last update posted
- Dec 22, 2009
2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01038362, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2009 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01038362 live on ClinicalTrials.gov.