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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Tufts University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Boston University
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00782015
First received: October 28, 2008
Last updated: December 7, 2009
Last verified: December 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical markers of inflammation, such as cytokines [ Time Frame: After 6 weeks of eating almonds ] [ Designated as safety issue: No ]
  • Biochemical markers of dyslipidemia, such as lipid profiles [ Time Frame: After 6 weeks of eating almonds ] [ Designated as safety issue: No ]
  • Biomarkers of oxidative stress, such as isoprostanes and 8OHdG [ Time Frame: After 6 weeks of eating almonds ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Almonds
    3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
    Other Name: Nuts
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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jean Mayer Human Nutrition Research Center on Aging at Tufts University (Dr. Paul E. Milbury), Jean Mayer Human Nutrition Research Center on Aging at Tufts University
ClinicalTrials.gov Identifier: NCT00782015     History of Changes
Other Study ID Numbers: TuftsIRB8723, HNRCA MRU2590
Study First Received: October 28, 2008
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Hypertension
Inflammation
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014