Walnut Consumption, Endothelial Function, and Biomarkers

Study Overview
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Brief Summary
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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.

Official Title
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Walnut Consumption, Endothelial Function, and Plasma Adipokines in Subjects With Diabetes or Coronary Disease: a Pilot Trial

Conditions
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Coronary Heart Disease, Type 2 Diabetes

Intervention / Treatment
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* Other: Once ounce per day of walnuts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walnuts<br>This group will receive one ounce of walnuts per day | Other: Once ounce per day of walnuts<br> <br> |
| No Intervention: Usual diet (no walnuts)<br>Control group (does not receive walnuts in the diet) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention) | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walnuts, Endothelial function, clinical trial, Nutrition, cardiovascular disease