Walnut Consumption, Endothelial Function, and Biomarkers

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884363
• Other study ID #: 2013P000803
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: March 16, 2016
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Other:
• Once ounce per day of walnuts

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Djousse L, Lu B, Gaziano JM. Effects of Walnut Consumption on Endothelial Function in People with Type 2 Diabetes: a Randomized Pilot Trial. Curr Nutr Rep 2016;5:1-8

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in heart rate variability between baseline and 12 weeks post-intervention	Change in heart rate variability will be measured in each group before and after 12 weeks.	12 weeks	No
Primary	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	No
Secondary	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	No