Clinical trial NCT00852475: Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Official title: Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: MUFA
PUFA
MOVE! program
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland
First posted: 2009-02-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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)

Detailed description: 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.

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 \< 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

Primary outcomes:
measure: Weight Changes in Veterans With MetS.
timeFrame: 6 months from Baseline
Secondary outcomes:
measure: Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .
timeFrame: 6 months from Baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Michael Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: