NCT00782015

Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease

Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vascular Disease
• Endothelial Dysfunction
• Heart Disease
• Cardiovascular Diseases
• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Almonds	3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
DIETARY_SUPPLEMENT	Placebo Comparator:	NCEP Step 2 diet

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-10-29
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States