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

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00852475
First received: February 26, 2009
Last updated: December 7, 2016
Last verified: December 2016
Results First Received: December 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Metabolic Syndrome
Interventions: Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)
Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MUFA

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

PUFA

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


Participant Flow:   Overall Study
    MUFA   PUFA
STARTED   26   20 
COMPLETED   23   16 
NOT COMPLETED   3   4 
Lost to Follow-up                3                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MUFA

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

PUFA

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 Total of all reporting groups

Baseline Measures
   MUFA   PUFA   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   20   46 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20  76.9%      18  90.0%      38  82.6% 
>=65 years      6  23.1%      2  10.0%      8  17.4% 
Gender 
[Units: Participants]
Count of Participants
     
Female      16  61.5%      12  60.0%      28  60.9% 
Male      10  38.5%      8  40.0%      18  39.1% 
Region of Enrollment 
[Units: Participants]
     
United States   26   20   86 


  Outcome Measures
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1.  Primary:   Weight Changes in Veterans With MetS.   [ Time Frame: 6 months from Baseline ]

2.  Secondary:   Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .   [ Time Frame: 6 months from Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Miller, MD
Organization: Baltimore VAMC and University of Maryland Medical Center
phone: 4103286299
e-mail: mmiller@medicine.umaryland.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00852475     History of Changes
Other Study ID Numbers: CARA-030-08F
HP-00040456 ( Other Identifier: Univ. of MD School of Med IRB )
Study First Received: February 26, 2009
Results First Received: December 22, 2014
Last Updated: December 7, 2016