Walnut Consumption, Endothelial Function, and Biomarkers

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Coronary Heart Disease
• Interventions: Other: Once ounce per day of walnuts

• Registration Number: NCT01884363
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Age 30+ years
• Prevalent coronary artery disease
• Prevalent type 2 diabetes

Exclusion Criteria

• Current eating disorder
• Pregnant or lactating women
• Allergy to walnuts or other nuts
• Inability to provide informed consent or blood samples
• History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
• Diagnosis of coronary heart disease or diabetes < 1 year prior to enrollment
• Intention to move out of greater Boston area within one year
• Current use of walnuts for more than 2 ounces per day
• Bleeding disorder
• Treatment with blood thinning drugs (i.e. warfarin, clopidogrel)
• Major surgical operation 3 months before or after screening
• Organ transplantation
• Current participation in another trial or plan to do so during the study
• Use of vasodilators such as nitroglycerin
• Inability to give informed consent
• Inability to travel to the study center at Brigham and Women's Hospital

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walnuts	Once ounce per day of walnuts	This group will receive one ounce of walnuts per day

Primary Outcome Measures

Name	Time	Method
Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)	12 weeks	Reactive hyperemia index (RHI), which in part reflects vasodilator function of the small blood vessel at the fingertips is an indirect measure of endothelial function. Change in RHI between baseline and 12 weeks post intervention will be measured in each group using EndoPat2000 device. We will compare RHI change between walnut group and usual diet group.

Secondary Outcome Measures

Name	Time	Method
Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)	12 weeks	Specifically, we will measure changes in blood levels of following hormones: retinol binding protein 4, fatty acid binding protein 4, total adiponectin, and leptin before and after 12 weeks of walnut consumption/consumption of usual diet.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States