Hypertension Clinical Trial
Official title:
Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease
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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