Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborator:	University of Maryland
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00852475

Purpose

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	Intervention
Metabolic Syndrome	Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet) Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Metabolic (lipid, glucose, insulin resistance), body composition (assessed via dual energy absorptiometry DXA and CT-scan), and CV fitness (assessed as maximal aerobic capacity, VO2max) abnormalities in Veterans with MetS. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endothelium-dependent FMD assessed by the brachial artery reactivity test (BART) at rest and after postprandial meal challenge (lipid and glucose) responses. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
(1) lipolytic enzymes and transfer proteins that mediate the lipid changes, (2) insulin resistance for glucose, (3) visceral adipose tissue area for lipids and glucose and (4) BART for vascular endothelial function and atherosclerosis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2010
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Assignment to monounsaturated enriched diet with the MUFA MOVE! program	Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet) MUFA diet and exercise program
Active Comparator: 2 PUFA diet MOVE! exercise	Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet) PUFA diet and exercise

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852475

Contacts

Contact: Michael Miller, MD

(410) 328-6299

mmiller@medicine.umaryland.edu

Locations

United States, Maryland
VA Maryland Health Care System, Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michael Miller, MD 410-328-6299 mmiller@medicine.umaryland.edu
Principal Investigator: Michael Miller, MD
Sub-Investigator: Kara Longo, MS
Sub-Investigator: Abigail M Roberts, BA

Sponsors and Collaborators

Department of Veterans Affairs

University of Maryland

Investigators

Principal Investigator:

Michael Miller, MD

VA Maryland Health Care System, Baltimore

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00852475 History of Changes
Other Study ID Numbers:	CARA-006-08F, HP-00040456, CARA-006-08F
Study First Received:	February 26, 2009
Last Updated:	September 28, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

MUFA
PUFA
MOVE! program

Additional relevant MeSH terms:

Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012