Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome

NCT00852475 | Completed Results

• 2 other identifiers: CARA-030-08FHP-00040456
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)

Conditions

Metabolic Syndrome

Keywords

MUFA; PUFA; MOVE! program

Outcome Measures

Primary Outcomes (1)

• Weight Changes in Veterans With MetS.

  6 months from Baseline

Secondary Outcomes (1)

• Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .

  6 months from Baseline

Study Arms (2)

MUFA

PLACEBO COMPARATOR

Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program

Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)

PUFA

ACTIVE COMPARATOR

Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program

Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)

Interventions

MUFA MOVE! (Monounsaturated fatty enriched diet) DIETARY_SUPPLEMENT

MUFA MOVE!diet and exercise program

MUFA

PUFA MOVE! (Polyunsaturated fatty acid enriched diet) DIETARY_SUPPLEMENT

PUFA MOVE! diet and exercise program

PUFA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Michael Miller, MD
• Organization: Baltimore VAMC and University of Maryland Medical Center

mmiller@medicine.umaryland.edu

4103286299

Study Officials

• Michael Miller, MD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 2, 2017
• Results First Posted: February 2, 2017

Record last verified: 2016-12

Locations

US (1)