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

Primary Purpose

Vascular Disease, Endothelial Dysfunction, Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almonds
Placebo Comparator:
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Disease focused on measuring almonds, heart disease, vascular reactivity, inflammation, dyslipidemia, oxidative stress

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

almonds

Placebo

Arm Description

3 oz/d almonds

NCEP Step 2 diet

Outcomes

Primary Outcome Measures

Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function.

Secondary Outcome Measures

Biochemical markers of inflammation, such as cytokines
Biochemical markers of dyslipidemia, such as lipid profiles
Biomarkers of oxidative stress, such as isoprostanes and 8OHdG

Full Information

First Posted
October 28, 2008
Last Updated
April 26, 2017
Sponsor
Tufts University
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT00782015
Brief Title
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
Official Title
Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Boston University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease, Endothelial Dysfunction, Heart Disease, Cardiovascular Diseases, Hypertension
Keywords
almonds, heart disease, vascular reactivity, inflammation, dyslipidemia, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
almonds
Arm Type
Active Comparator
Arm Description
3 oz/d almonds
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NCEP Step 2 diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Almonds
Other Intervention Name(s)
Nuts
Intervention Description
3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator:
Intervention Description
NCEP Step 2 diet
Primary Outcome Measure Information:
Title
Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function.
Time Frame
After 6 weeks eating almonds
Secondary Outcome Measure Information:
Title
Biochemical markers of inflammation, such as cytokines
Time Frame
After 6 weeks of eating almonds
Title
Biochemical markers of dyslipidemia, such as lipid profiles
Time Frame
After 6 weeks of eating almonds
Title
Biomarkers of oxidative stress, such as isoprostanes and 8OHdG
Time Frame
After 6 weeks of eating almonds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Blumberg, PhD
Organizational Affiliation
HNRCA Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Vita, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26080804
Citation
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.
Results Reference
derived

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

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