Status:
COMPLETED
Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome
Lead Sponsor:
Griffin Hospital
Collaborating Sponsors:
California Walnut Commission
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief 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...
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 leas...
Eligibility Criteria
Inclusion
- 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
- fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L)
- fasting serum triglycerides level (TG) \> 150 mg/dL (1.69 mmol/L)
- fasting high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L)in men, and \< 50 mg/dL (1.29 mmol/L) in women.
Exclusion
- Anticipated inability to complete or comply with study protocol
- Use of lipid-lowering or antihypertensive medications or aspirin unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning
- Preexisting cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease, congestive heart failure, carotid stenosis)
- Severe hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg), even if well-controlled by medication.
- Diagnosed diabetes mellitus
- Regular use of multivitamins, Vitamin C, Vitamin E, fish oil, flax seed oil, omega-3 fatty acids, CoQ10, fiber supplements, garlic pills, arginine, red yeast rice, and any kind of antioxidant and unwillingness to discontinue supplementation for at least 4 weeks prior to study initiation and for study duration
- Allergic to walnuts or any other nuts
- Diagnosed eating disorder
- On any specific diet, weight control diet, vegan diet
- Any rheumatologic disease requiring regular use of NSAIDs or alternative medications
- Regular use of fiber supplements
- Regular use of vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), and anticoagulant drugs (including Coumadin, plavix )
- Diagnosed sleep apnea
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- Current or impending pregnancy
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01413646
Start Date
February 1 2010
End Date
December 1 2010
Last Update
August 2 2019
Active Locations (1)
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1
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418