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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00852475
• Collaborator: University of Maryland (Other)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 58
• Patients Per Site Per Month: 0.8

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet); Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: MUFA Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program	Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet); MUFA MOVE!diet and exercise program
Active Comparator: PUFA Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program	Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet); PUFA MOVE! diet and exercise program

Outcome Measures

Primary Outcome Measures

1. Weight Changes in Veterans With MetS. [6 months from Baseline]

Secondary Outcome Measures

1. Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest . [6 months from Baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• VA Office of Research and Development
• University of Maryland

Investigators

• Principal Investigator: Michael Miller, MD, VA Maryland Health Care System, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00852475
• Other Study ID Numbers: CARA-030-08F; HP-00040456
• First Posted: Feb 27, 2009
• Last Update Posted: Feb 2, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by VA Office of Research and Development: MUFA; PUFA; MOVE! program
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

Participant Flow

Arm/Group Title	MUFA	PUFA
Arm/Group Description	Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program	Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
Period Title: Overall Study
STARTED	26	20
COMPLETED	23	16
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	MUFA	PUFA	Total
Arm/Group Description	Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program	Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program	Total of all reporting groups
Overall Participants	26	20	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 76.9%	18 90%	38 82.6%
>=65 years	6 23.1%	2 10%	8 17.4%
Gender (Count of Participants)
Female	16 61.5%	12 60%	28 60.9%
Male	10 38.5%	8 40%	18 39.1%
Region of Enrollment (participants) [Number]
United States	26 100%	20 100%	86 187%

Outcome Measures

1. Primary Outcome

Title	Weight Changes in Veterans With MetS.
Time Frame	6 months from Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MUFA	PUFA
Arm/Group Description	Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program	Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
Measure Participants	23	16
Mean (Standard Error) [kg]	-2.3 (0.99)	-6.2 (1.2)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MUFA Arm	PUFA Arm
Arm/Group Description	Assessment of FMD after six months of MUFA enrichment	Assessment of FMD after 6 months of PUFA enrichment
Measure Participants	23	16
Mean (Standard Error) [percentage of change from baseline]	0.19 (0.29)	1.5 (0.38)

Adverse Events

Time Frame	6 months
Arm/Group Title	MUFA		PUFA
Arm/Group Description	subjects received a diet enriched in MUFA		subjects received a diet enriched in PUFA
All Cause Mortality
	MUFA		PUFA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MUFA		PUFA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	MUFA		PUFA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.