Effects of Almonds on Vascular Reactivity 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.
|Vascular Disease Endothelial Dysfunction Heart Disease Cardiovascular Diseases Hypertension||Dietary Supplement: Almonds Dietary Supplement: Placebo Comparator:|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease|
- Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function. [ Time Frame: After 6 weeks eating almonds ]
- Biochemical markers of inflammation, such as cytokines [ Time Frame: After 6 weeks of eating almonds ]
- Biochemical markers of dyslipidemia, such as lipid profiles [ Time Frame: After 6 weeks of eating almonds ]
- Biomarkers of oxidative stress, such as isoprostanes and 8OHdG [ Time Frame: After 6 weeks of eating almonds ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: almonds
3 oz/d almonds
Dietary Supplement: Almonds
3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
Other Name: Nuts
Placebo Comparator: Placebo
NCEP Step 2 diet
Dietary Supplement: Placebo Comparator:
NCEP Step 2 diet
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782015
|United States, Massachusetts|
|Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Jeffrey B Blumberg, PhD||HNRCA Tufts University|
|Principal Investigator:||Joseph Vita, MD||Boston University|