Clinical Trials Directory

Trials / Completed

CompletedNCT01413646

Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome

Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome: A Randomized, Controlled, Cross-Over Trial

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

Summary

The purpose of this study is to examine the effects of walnut consumption on endothelial function and lipid markers in overweight patients with at least one factor of metabolic syndrome as compared to the control group.

Detailed description

The prevalence of obesity in both adults and children in the United States has increased significantly over the past 50 years. More than 66% of adults in the US are now overweight or obese and at least 17% of children in the population at large are now considered overweight.Obesity may be a factor predisposing patients to a myriad of comorbidities that increase the associated mortality rate.Several large prospective trials have documented that obesity is an independent risk factor for mortality from cardiovascular disease (CVD). Considering the major metabolic and biochemical changes that occur in obesity, such as atherogenic dyslipidemia, insulin resistance and hyperinsulinemia, endothelial dysfunction, and chronic inflammatory and prothrombotic states, obesity plays a role in the pathogenesis of systemic atherosclerosis and its clinical complications. Walnuts are rich in alpha-linolenic acid, an essential omega-3 fatty acid, L-arginine and antioxidants. Polyunsaturated fatty acids and antioxidants have anti-oxidative effects and are thought to help preserve the endothelium's capacity to generate nitric oxide (NO), which acts to promote vasodilation, stabilize platelets, and promote the anti-inflammatory abilities of the endothelium. Evidence of this anticipated effect would have implications for strategies to prevent or retard type 2 diabetes mellitus and cardiovascular disease. Endothelial function testing using high frequency ultrasound imaging of the brachial artery to assess endothelium-dependent flow-mediated dilatation (FMD) offers a non-invasive, uniquely valuable means of assessing aggregated influences on cardiac risk by gauging a physiologic response of the vascular endothelium. Proposed, therefore, is a randomized, controlled, cross-over clinical trial, to assess the effects of walnuts on endothelial function in overweight adults with elevated waist circumference and at least one risk factor of metabolic syndrome.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTWalnut SupplementationEight weeks of walnut supplementation
DIETARY_SUPPLEMENTNo walnut supplementationEight weeks without walnut supplementation

Timeline

Start date
2010-02-01
Primary completion
2010-10-01
Completion
2010-12-01
First posted
2011-08-10
Last updated
2019-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01413646. Inclusion in this directory is not an endorsement.