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Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome (MUFAPUFA)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MUFA MOVE! (Monounsaturated fatty enriched diet)
PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring MUFA, PUFA, MOVE! program

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Maryland Health Care System, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

MUFA

PUFA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight Changes in Veterans With MetS.

Secondary Outcome Measures

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.

Full Information

First Posted
February 26, 2009
Last Updated
December 7, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT00852475
Brief Title
Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Acronym
MUFAPUFA
Official Title
Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Maryland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
MUFA, PUFA, MOVE! program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUFA
Arm Type
Placebo Comparator
Arm Description
Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
Arm Title
PUFA
Arm Type
Active Comparator
Arm Description
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
Intervention Type
Dietary Supplement
Intervention Name(s)
MUFA MOVE! (Monounsaturated fatty enriched diet)
Intervention Description
MUFA MOVE!diet and exercise program
Intervention Type
Dietary Supplement
Intervention Name(s)
PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
Intervention Description
PUFA MOVE! diet and exercise program
Primary Outcome Measure Information:
Title
Weight Changes in Veterans With MetS.
Time Frame
6 months from Baseline
Secondary Outcome Measure Information:
Title
Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .
Description
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.
Time Frame
6 months from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Miller, MD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome

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