Clinical Trials Directory

Trials / Completed

CompletedNCT00901043

Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes

Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross-over Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Griffin Hospital · Academic / Other
Sex
All
Age
35 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.

Detailed description

Evidence-based guidelines for the management of type 2 diabetes mellitus and related cardiovascular disease (CVD) refer to cardioprotective dietary fatty acid proportions. Several studies demonstrate the hypocholesteremic effects of walnuts in energy restricted diets. To our knowledge, the health benefits accrued as a result of addition of walnuts to an ad libitum diet in type 2 diabetic subjects have not been studied. Addition of walnuts to an ad libitum diet represents a practical way to achieve the recommended fatty acid proportions. The proposed study will examine whether a total dietary pattern inclusive of walnuts, will result in amelioration of cardiac risk as measured by improvement in endothelial function and glycemic control in type 2 diabetics. Results of the study will have important implications for clinicians and dietitians in dietary management of type 2 diabetes. Demonstrating that walnuts can be regarded as beneficial components of dietary management of type 2 diabetes is of relevance to the walnut industry as well. The study employs a pragmatic approach to approximate dietary practices in a real world setting thus enhancing the external validity of the study. If positive, the study results can inform future marketing efforts of the California Walnut Commission. Demonstrating that addition of walnuts to an ad libitum diet can potentially lead to improvement in endothelial function, improve lipid profiles, glycemic control and reduce the risk of CVD complications in diabetic patients has important applications for dietary management of diabetes.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTWalnut supplementationEight weeks of walnut supplementation
DIETARY_SUPPLEMENTAd lib dietEight weeks without walnut supplementation

Timeline

Start date
2007-10-01
Primary completion
2008-07-01
Completion
2008-09-01
First posted
2009-05-13
Last updated
2020-03-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00901043. Inclusion in this directory is not an endorsement.