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

NCT ID: NCT00782015

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

almonds

3 oz/d almonds

Group Type: ACTIVE_COMPARATOR

Almonds

Intervention Type: DIETARY_SUPPLEMENT

3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.

Placebo

NCEP Step 2 diet

Group Type: PLACEBO_COMPARATOR

Placebo Comparator:

Intervention Type: DIETARY_SUPPLEMENT

NCEP Step 2 diet

Interventions

Almonds

3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator:

NCEP Step 2 diet

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Nuts

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Blumberg

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey B Blumberg, PhD

Role: PRINCIPAL_INVESTIGATOR

HNRCA Tufts University

Joseph Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)

Boston, Massachusetts, United States

Countries

United States

References

Chen CY, Holbrook M, Duess MA, Dohadwala MM, Hamburg NM, Asztalos BF, Milbury PE, Blumberg JB, Vita JA. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial. Nutr J. 2015 Jun 17;14:61. doi: 10.1186/s12937-015-0049-5.

Reference Type: DERIVED

PMID: 26080804 (View on PubMed)

Other Identifiers

TuftsIRB8723

Identifier Type: -

Identifier Source: org_study_id