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

NCT00782015 | Completed

• 1 other identifier: TuftsIRB8723
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease; Endothelial Dysfunction; Heart Disease; Cardiovascular Diseases; Hypertension

Keywords

almonds; heart disease; vascular reactivity; inflammation; dyslipidemia; oxidative stress

Outcome Measures

Primary Outcomes (1)

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

  After 6 weeks eating almonds

Secondary Outcomes (3)

• Biochemical markers of inflammation, such as cytokines

  After 6 weeks of eating almonds

• Biochemical markers of dyslipidemia, such as lipid profiles

  After 6 weeks of eating almonds

• Biomarkers of oxidative stress, such as isoprostanes and 8OHdG

  After 6 weeks of eating almonds

Study Arms (2)

almonds

ACTIVE COMPARATOR

3 oz/d almonds

Dietary Supplement: Almonds

Placebo

PLACEBO COMPARATOR

NCEP Step 2 diet

Dietary Supplement: Placebo Comparator:

Interventions

Almonds DIETARY_SUPPLEMENT

3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.

Also known as: Nuts

almonds

Placebo Comparator: DIETARY_SUPPLEMENT

NCEP Step 2 diet

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead
• Boston University: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 26080804 DERIVED

MeSH Terms

Conditions

Vascular Diseases; Heart Diseases; Cardiovascular Diseases; Hypertension; Inflammation; Dyslipidemias

Interventions

Nuts

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jeffrey B Blumberg, PhD

  HNRCA Tufts University

  PRINCIPAL INVESTIGATOR

• Joseph Vita, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)