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| Name | Class |
|---|---|
| Boston University | OTHER |
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This is a study of the effects of 3 oz almonds added daily to a National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function in patients with Coronary Artery Disease. The study seeks to determine if these effects are mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and systemic inflammation.
Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia, inflammation, endothelial function, vascular reactivity and oxidative stress.
The study is a randomized, crossover, 6 week intervention trial design with a 6 week run in on the TLC diet and a 6 week washout on the TLC diet between control and intervention periods. Forty subjects with verified and stable coronary artery disease will be enrolled in the study. The control intervention involved maintaining a steady TLC diet without nuts which will be monitored with counseling and dietary assessments. The almond intervention involved consuming 3 oz. of almonds per day and adjusting lipid intake to remain isocaloric with the TLC diet alone. Again subjects will be monitored with counseling and dietary assessments.
At the beginning and end of each intervention period subjects will be tested for endothelial function using flow mediated dilation and blood and urine samples will be collected for biochemical analysis for markers of inflammation, dyslipidemia, and oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| almonds | Active Comparator | 3 oz/d almonds |
|
| Placebo | Placebo Comparator | NCEP Step 2 diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonds | Dietary Supplement | 3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function. | After 6 weeks eating almonds |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical markers of inflammation, such as cytokines | After 6 weeks of eating almonds | |
| Biochemical markers of dyslipidemia, such as lipid profiles | After 6 weeks of eating almonds | |
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Inclusion Criteria:
Exclusion Criteria:
All vasoactive medications (nitrates, calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors, and other vasodilators). Subjects will take their medications immediately after the ultrasound measurements are taken.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Blumberg, PhD | HNRCA Tufts University | Principal Investigator |
| Joseph Vita, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA) | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26080804 | Derived | Chen CY, Holbrook M, Duess MA, Dohadwala MM, Hamburg NM, Asztalos BF, Milbury PE, Blumberg JB, Vita JA. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial. Nutr J. 2015 Jun 17;14:61. doi: 10.1186/s12937-015-0049-5. |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D007249 | Inflammation |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D009754 | Nuts |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo Comparator: | Dietary Supplement | NCEP Step 2 diet |
|
| Biomarkers of oxidative stress, such as isoprostanes and 8OHdG |
| After 6 weeks of eating almonds |
| D009750 | Nutritional and Metabolic Diseases |