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| ID | Type | Description | Link |
|---|---|---|---|
| HP-00040456 | Other Identifier | Univ. of MD School of Med IRB |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MUFA | Placebo Comparator | Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program |
|
| PUFA | Active Comparator | Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUFA MOVE! (Monounsaturated fatty enriched diet) | Dietary Supplement | MUFA MOVE!diet and exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Changes in Veterans With MetS. | 6 months from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest . | 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. |
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Inclusion Criteria:
Presence of 3 or more of the following):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Miller, MD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MUFA | Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program |
| FG001 | PUFA | Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MUFA | Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program |
| BG001 | PUFA |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Changes in Veterans With MetS. | Posted | Mean | Standard Error | kg | 6 months from Baseline |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MUFA | subjects received a diet enriched in MUFA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Miller, MD | Baltimore VAMC and University of Maryland Medical Center | 4103286299 | mmiller@medicine.umaryland.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| PUFA MOVE! (Polyunsaturated fatty acid enriched diet) | Dietary Supplement | PUFA MOVE! diet and exercise program |
|
| 6 months from Baseline |
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest . | 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. | Posted | Mean | Standard Error | percentage of change from baseline | 6 months from Baseline |
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| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | PUFA | subjects received a diet enriched in PUFA | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |