N/A
Completed N=46
Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Source: ClinicalTrials.gov NCT00852475 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Weight Changes in Veterans With MetS. — -2.3; -6.2 kg
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Changes in Veterans With MetS. |
-2.3; -6.2 | — |
| SECONDARY Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest . |
0.19; 1.5 | — |
Eligibility Criteria
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 100 mg/dL (based on 2006 guidelines)
- Treated Hyperlipidemia or Untreated Triglycerides > 150 mg/dL
- HDL-C 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
Data sourced from ClinicalTrials.gov (NCT00852475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.