Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02111


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

TuftsIRB8723


NCT ID:

NCT00782015


Secondary ID:

HNRCA MRU2590


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tufts University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jeffrey B Blumberg, PhD
Principal Investigator
HNRCA Tufts University

Study Dates

Start Date:October 2008
Completion Date:November 2010
Completion Type:Anticipated
Primary Completion Date:December 2009
Primary Completion Type:Anticipated
Verification Date:December 2009
Last Changed Date:December 7, 2009
First Received Date:October 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Biomarkers of oxidative stress, such as isoprostanes and 8OHdG
Time Frame:After 6 weeks of eating almonds
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Biochemical markers of dyslipidemia, such as lipid profiles
Time Frame:After 6 weeks of eating almonds
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Biochemical markers of inflammation, such as cytokines
Time Frame:After 6 weeks of eating almonds
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function.
Time Frame:After 6 weeks eating almonds
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Almonds
Description:3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
Other Name:Nuts

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Tufts University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Boston University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.