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The Effects of Leucine on Body Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683826
First Posted: May 26, 2008
Last Update Posted: March 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Henry N. Ginsberg, Columbia University
Results First Submitted: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Overweight
Obesity
Interventions: Dietary Supplement: L-Leucine 8gr
Other: Liquid meal
Dietary Supplement: L-Leucine 4g

  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
Recruitment was completed. All subjects were recruited from the surrounding neighborhood and affiliates of Columbia University Medical Center (CUMC).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Study Participants This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.

Participant Flow:   Overall Study
    All Study Participants
STARTED   8 
0g Leucine   8 
8g Leucine   8 
4g Leucine   7 
COMPLETED   7 
NOT COMPLETED   1 



  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.
No text entered.

Reporting Groups
  Description
Leucine 4 Grams Initial intervention.
Leucine 8 Grams Initial intervention.
Leucine 0 Grams-control Initial intervention.
Total Total of all reporting groups

Baseline Measures
   Leucine 4 Grams   Leucine 8 Grams   Leucine 0 Grams-control   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   3   3   8 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   2   3   3   8 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (7)   40  (7)   45  (7)   40  (7) 
Gender 
[Units: Participants]
       
Female   1   3   3   7 
Male   1   0   0   1 
Region of Enrollment 
[Units: Participants]
       
United States   2   3   3   8 


  Outcome Measures

1.  Primary:   Effects on Weight   [ Time Frame: 4 weeks ]

2.  Primary:   Weight   [ Time Frame: at the end of each study treatment arm (six weeks) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Energy Expenditure   [ Time Frame: will be measure at the end of each treatment period (6 weeks) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Henry N. Ginsberg MD, Gissette Reyes Soffer MD
Organization: Columbia University Medical Center
phone: 2123059298
e-mail: gr2104@columbia.edu



Responsible Party: Henry N. Ginsberg, Columbia University
ClinicalTrials.gov Identifier: NCT00683826     History of Changes
Other Study ID Numbers: AAAC6762
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: March 1, 2011
Results First Posted: August 9, 2011
Last Update Posted: March 5, 2013