Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome (MUFAPUFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852475
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development

February 26, 2009
February 27, 2009
December 22, 2014
February 2, 2017
February 2, 2017
February 2010
December 2014   (Final data collection date for primary outcome measure)
Weight Changes in Veterans With MetS. [ Time Frame: 6 months from Baseline ]
Metabolic (lipid, glucose, insulin resistance), body composition (assessed via dual energy absorptiometry DXA and CT-scan), and CV fitness (assessed as maximal aerobic capacity, VO2max) abnormalities in Veterans with MetS. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00852475 on Archive Site
Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest . [ Time Frame: 6 months from Baseline ]
Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.
  • Endothelium-dependent FMD assessed by the brachial artery reactivity test (BART) at rest and after postprandial meal challenge (lipid and glucose) responses. [ Time Frame: 2 years ]
  • (1) lipolytic enzymes and transfer proteins that mediate the lipid changes, (2) insulin resistance for glucose, (3) visceral adipose tissue area for lipids and glucose and (4) BART for vascular endothelial function and atherosclerosis. [ Time Frame: 2 yrs ]
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Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome

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)

The Metabolic Syndrome (MetS) is a common problem among Veterans and is associated with a greater likelihood of cardiovascular disease (CVD). The Mediterranean diet is the only popular diet that has been shown to reduce CVD event rates but the extent to which monounsaturated fatty acid (MUFA) or polyunsaturated fatty acid (PUFA) enrichment results in improvement in parameters of MetS is unresolved. Similarly, while low intensity exercise improves the CVD risk factor profile, there have been no comparative investigations comparing MUFA and PUFA enriched diets and exercise in patients with MetS that have extended beyond 1 year. Recently, the VA established the MOVE! program, a national weight management program designed to help Veterans lose weight. Using the VA promoted program, we will perform a systematic evaluation of the effects of dietary fat composition [comparison between MUFA-enriched and PUFA enriched diet] with MOVE!. We hypothesize that a MUFA-enriched diet consisting of antioxidant, lipid reducing and insulin sensitizing properties will be superior to the less palatable PUFA-enriched diet on improving cardiometabolic parameters associated with MetS. Specifically, the MUFA MOVE! program is expected to lead to greater improvements than the PUFA MOVE! program in body composition and aerobic fitness (Specific Aim 1), endothelial dependent flow mediated vasodilatation and the postprandial lipid response to a meal load (Specific Aim 2) and the mechanisms (lipolytic and lipid transfer protein activity, homeostasis model assessment-estimated insulin resistance) responsible for these effects (Specific Aim 3). Collectively, these studies will advance our understanding of mechanisms underlying the differential effects of MUFA and PUFA-enriched dietary regimens on cardiometabolic health and when combined with the MOVE! program, will provide new and useful information to Veterans (and the general public) interested in optimizing their diets for CVD disease prevention and improved vascular health.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Metabolic Syndrome
  • Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)
    MUFA MOVE!diet and exercise program
  • Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
    PUFA MOVE! diet and exercise program
  • Placebo Comparator: MUFA
    Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
    Intervention: Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)
  • Active Comparator: PUFA
    Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
    Intervention: Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
HP-00040456 ( Other Identifier: Univ. of MD School of Med IRB )
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
University of Maryland
Principal Investigator: Michael Miller, MD VA Maryland Health Care System, Baltimore
VA Office of Research and Development
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP