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View Clinical Trial (Medical Research Study)
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Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome - NCT00852475-21201 (Clinical Trial 274855)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy274855.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21201 |
| Conditions: |
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Metabolic Syndrome |
| Purpose: |
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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)
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| Study summary: |
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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 vasodilation 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. |
| Criteria: |
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Inclusion Criteria:
Inclusion (Presence of 3 or more of the following):
1. Waist circumference greater than 102 cm in men or 88 cm in women
2. Blood pressure greater than 130/85 and less than 160/100 mm Hg
3. Fasting blood glucose (FBG) greater than 100 mg/dL (based on 2006 guidelines)
4. Triglycerides greater than 150 mg/dL
5. HDL-C less than 40 mg/dL men less than 50 mg/dL women
Exclusion Criteria:
1. Chronic heart, pulmonary or renal (Cr greater than 2mg/dL) or inflammatory disorders
2. Treated diabetes mellitus or FBG greater than 180 mg/dL
3. Hematologic or malignant disorders
4. SBP greater than 160 mm Hg, LDL-C greater than 160 or TG greater than 500 mg/dL
5. Use of systemic vasodilators (e.g., nitrates)
6. Use of medications affecting BART (e.g., statins, ACEI, ARBs, fibrates,
beta-blockers)
7. Morbid Obesity (BMI greater than 40 kg/m2)
8. Endocrine (thyroid) or metabolic disorders (unless treated and under control)
9. Alcohol consumption greater than 1 ounce daily (i.e., ingestion of greater than or
equal to (2) 4-ounce glasses of table wine, (2) 12-oz bottles of beer or 2 shots of
spirits in men or that amount in women). |
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| Study is available at: |
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VA Maryland Health Care System, Baltimore
Baltimore, MD 21201
United States
Primary Contact:
Michael Miller, MD
Email: mmiller@medicine.umaryland.edu
Phone: (410) 328-6299 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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