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| Name | Class |
|---|---|
| California Walnut Commission | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walnut Supplementation | Experimental | Eight weeks with walnut supplementation to an ad lib diet |
|
| 2 | Placebo Comparator | Eight weeks ad lib diet without walnut supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walnut Supplementation | Dietary Supplement | Eight weeks of walnut supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Brachial artery flow mediated dilation (FMD) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 8 weeks | |
| Waist circumference | 8 weeks | |
| Fasting lipid panel |
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Inclusion Criteria:
Male and female age 25-75 years
Non-smoker
Overweight (BMI ≥ 25) with central adiposity as indicated by waist circumference (102 cm. in men / 88 cm. in women)
Meet one risk factor of the metabolic syndrome.
blood pressure > 130/85 or taking antihypertensive medication
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Katz, MD, MPH | Yale-Griffin Prevention Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-Griffin Prevention Research Center | Derby | Connecticut | 06418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23756586 | Derived | Katz DL, Davidhi A, Ma Y, Kavak Y, Bifulco L, Njike VY. Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial. J Am Coll Nutr. 2012 Dec;31(6):415-23. doi: 10.1080/07315724.2012.10720468. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| No walnut supplementation |
| Dietary Supplement |
Eight weeks without walnut supplementation |
|
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
| 8 weeks |
| Fasting blood glucose | 8 weeks |
| Fasting insulin | 8 weeks |
| Blood pressure | 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |