Coronary Heart Disease, Type 2 Diabetes
Conditions
Keywords
Endothelial function, walnuts, clinical trial, Nutrition, cardiovascular disease
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.
Interventions
OTHEROnce ounce per day of walnuts
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate variability between baseline and 12 weeks post-intervention | 12 weeks | Change in heart rate variability will be measured in each group before and after 12 weeks. |
Countries
United States
Outcome results
None listed