Status:
COMPLETED
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
Lead Sponsor:
Tufts University
Collaborating Sponsors:
Boston University
Conditions:
Vascular Disease
Endothelial Dysfunction
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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 Coron...
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 subject...
Eligibility Criteria
Inclusion
- Stable CAD Patients (men \& postmenopausal women)
- aged 20-80 years
- weighing less than 115 Kg (BMI range 18.5-35 kg/m2)
- with coronary artery disease defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
- Subjects are eligible to participate after a stent procedure only after they have been stable for one month after the stent procedure.
- All Ethnic Groups.
- Languages: English
Exclusion
- Subjects with heart failure are not eligible for participation in this study.
- History or known allergy to nuts of any kind
- Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
- Regular use of oral steroids
- Cigarette smoking and/or nicotine replacement use
- Regular daily intake of ≥ 2 alcoholic drinks
- Illicit drug use
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
- Treatment with an investigational new drug within the last 30 days.
- Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).
- The following medications will be withheld in the morning of each ultrasound study visit as follows:
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00782015
Start Date
October 1 2008
End Date
January 1 2011
Last Update
April 28 2017
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)
Boston, Massachusetts, United States, 02111