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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT00782015

Collaborator

Boston University (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Disease Endothelial Dysfunction Heart Disease Cardiovascular Diseases Hypertension	Dietary Supplement: Almonds Dietary Supplement: Placebo Comparator:	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Nuts
Placebo Comparator: Placebo NCEP Step 2 diet	Dietary Supplement: Placebo Comparator: NCEP Step 2 diet

Arm

Intervention/Treatment

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 Names:

Nuts

Placebo Comparator: Placebo

NCEP Step 2 diet

Dietary Supplement: Placebo Comparator:

NCEP Step 2 diet

Outcome Measures

Primary Outcome Measures

Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function. [After 6 weeks eating almonds]

Secondary Outcome Measures

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]
Biomarkers of oxidative stress, such as isoprostanes and 8OHdG [After 6 weeks of eating almonds]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.