COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00782015
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : April 28, 2017
Boston University
Information provided by (Responsible Party):
Jeffrey Blumberg, Tufts University

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: Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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 Name: Nuts

Placebo Comparator: Placebo
NCEP Step 2 diet
Dietary Supplement: Placebo Comparator:
NCEP Step 2 diet

Primary Outcome Measures :
  1. Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function. [ Time Frame: After 6 weeks eating almonds ]

Secondary Outcome Measures :
  1. Biochemical markers of inflammation, such as cytokines [ Time Frame: After 6 weeks of eating almonds ]
  2. Biochemical markers of dyslipidemia, such as lipid profiles [ Time Frame: After 6 weeks of eating almonds ]
  3. Biomarkers of oxidative stress, such as isoprostanes and 8OHdG [ Time Frame: After 6 weeks of eating almonds ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782015

Layout table for location information
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Boston University
Layout table for investigator information
Principal Investigator: Jeffrey B Blumberg, PhD HNRCA Tufts University
Principal Investigator: Joseph Vita, MD Boston University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jeffrey Blumberg, PI, Tufts University Identifier: NCT00782015    
Other Study ID Numbers: TuftsIRB8723
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Jeffrey Blumberg, Tufts University:
heart disease
vascular reactivity
oxidative stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Arterial Occlusive Diseases