Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome (MUFAPUFA)
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|ClinicalTrials.gov Identifier: NCT00852475|
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
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)
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet) Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: MUFA
Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)
MUFA MOVE!diet and exercise program
Active Comparator: PUFA
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
PUFA MOVE! diet and exercise program
- Weight Changes in Veterans With MetS. [ Time Frame: 6 months from Baseline ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852475
|United States, Maryland|
|VA Maryland Health Care System, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Michael Miller, MD||VA Maryland Health Care System, Baltimore|