Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease

NCT ID: NCT01038362

Last Updated: 2009-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-12-31

Brief Summary

The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. In patients with atherosclerosis, these functions of the endothelium are impaired and these abnormalities may contribute to the development of heart attack and stroke.

Observational studies have shown that frequent nut consumption decreases the risk of cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined. Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable effects on cardiovascular disease. In addition, there is growing evidence that these compounds may improve the function of the endothelium.

The present study is designed to test the hypothesis that an almond-enriched diet will improve the function of the endothelium in patients with coronary artery disease. Subjects will be enrolled into a randomized, placebo-controlled, crossover study that will compare a National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the same number of total calories but includes 3 ounces of almonds daily. Participants will consume each diet for six weeks with a four-week rest period between diets. The order of diets will be randomized (almonds or no almonds). Dietary assessments via food recall questionnaires will be employed at the study entry, end of the four week washout period, and end of the second intervention. If subjects are drifting from the recommendations of the STEP 1 diet, counseling will be given to urge compliance. The primary endpoint will be endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study outcomes will include lipid profiles, markers of inflammation and oxidative stress. Enrollment will continue until 40 subjects with complete data are available.

Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood collection will be performed in the principal investigator's research unit at Boston Medical Center.

Conditions

Coronary Artery Disease

Keywords

endothelium; almonds; dietary interventions; coronary artery disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Almonds

National Cholesterol Education Program Step I diet plus almonds for 6 weeks

Group Type: ACTIVE_COMPARATOR

NCEP Step 1 diet plus Almonds

Intervention Type: OTHER

NCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks

No Almonds

National Cholesterol Education Program Step 1 diet without almonds for 6 weeks

Group Type: PLACEBO_COMPARATOR

No Almonds

Intervention Type: OTHER

NCEP Step 1 diet without almonds

Interventions

NCEP Step 1 diet plus Almonds

NCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks

Intervention Type: OTHER

No Almonds

NCEP Step 1 diet without almonds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male and Female subjects.

2. Age range: 21-80 years old.

3. Weight less than 115 kg.

4. Clinically defined coronary artery disease that is clinical stable and compensated with appropriate treatment. Coronary disease (CVD) is defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.

5. Willingness to give written informed consent and willingness and ability to understand, to participate to and to comply with the study requirements.

Exclusion Criteria

1. History of nut allergy.

2. Pregnant or lactating women. Pregnancy will be excluded by urine pregnancy test.

3. 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.

4. Treatment with an investigational new drug within the last 30 days.

5. History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.

6. Unwillingness to comply with the requirements of study including refraining from consumption of nuts and refraining from use of Vitamin E, vitamin C, and beta carotene, lipoic acid, and/or other dietary or herbal supplements during the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts University

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Boston University School of Medicine

Principal Investigators

Joseph A Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-27411

Identifier Type: -

Identifier Source: org_study_id