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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782015
First Posted: October 29, 2008
Last Update Posted: April 28, 2017
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.
Collaborator:
Boston University
Information provided by (Responsible Party):
Jeffrey Blumberg, Tufts University
  Purpose

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 Intervention
Vascular Disease Endothelial Dysfunction Heart Disease Cardiovascular Diseases Hypertension Dietary Supplement: Almonds Dietary Supplement: Placebo Comparator:

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jeffrey Blumberg, Tufts University:

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

Enrollment: 45
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00782015


Locations
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
Investigators
Principal Investigator: Jeffrey B Blumberg, PhD HNRCA Tufts University
Principal Investigator: Joseph Vita, MD Boston University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Blumberg, PI, Tufts University
ClinicalTrials.gov Identifier: NCT00782015     History of Changes
Other Study ID Numbers: TuftsIRB8723
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Jeffrey Blumberg, Tufts University:
almonds
heart disease
vascular reactivity
inflammation
dyslipidemia
oxidative stress

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases