Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so as to determine which one is superior in reducing cardiometabolic risk factors associated with Metabolic Syndrome. The risk factors considered include lipids and lipoproteins, inflammatory markers such as CRP and adiponectin, endothelium-dependent flow-mediated vasodilatation (FMD) and the postprandial lipid responses to a meal. Cardiometabolic risk factors will be determined by measuring several cardiovascular risk associated parameters including: Biochemical measurements of lipids and inflammatory markers, body composition and VO2max (Specific Objective 1, Descriptive). Postprandial response to a meal challenge and endothelial vasoreactivity (FMD) assessed by BART (Specific Objective 2, Physiological). Determination of the effects on postheparin lipases and transfer protein activity, visceral adipose tissue (VAT) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) (Specific Objective 3, Mechanistic)

Key facts

Study ID

NCT00852475

Run by

VA Office of Research and Development

People needed

46

Starts

2010-02-01

Expected to finish

2014-12-01

Last updated by the study team

2017-02-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Presence of 3 or more of the following):
• Waist circumference >102 cm in men or >88 cm women
• Treated Hypertension or Untreated Blood pressure >130/85 and < 160/100 mm Hg
• Treated Hyperglycemia or Untreated Fasting blood glucose (FBG) >100 mg/dL (based on 2006 guidelines)
• Treated Hyperlipidemia or Untreated Triglycerides > 150 mg/dL
• HDL-C < 40 mg/dL men < 50 mg/dL women

You may not qualify if…

• Decompensated heart failure (NYHA Class IV);
• Severe Pulmonary disease (Unable to walk on a treadmill at 2.5 mph or greater);
• Chronic renal insufficiency (Cr > 2.5 mg/dL)
• Treated diabetes mellitus with FBG > 180 mg/dL or HbA1C >9g %
• Hematologic or malignant disorders
• Treated SBP >160 mmHg and/or DBP > 95 mmHg ;
• Treated TG > 250 mg/dL
• Use of systemic vasodilators (e.g., nitrates)
• Morbid Obesity (BMI > 50 kg/m2)
• Endocrine (thyroid) or metabolic disorders (unless treated and under control)
• Alcohol consumption greater than (2) 4-ounce glasses of table wine, (2) 12-oz bottles of beer or 2 shots of spirits in men or women
• Active IV drug abuse within the past 6 months

Where it is running

• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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