The Effects of Leucine on Body Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry N. Ginsberg, Columbia University
ClinicalTrials.gov Identifier:
NCT00683826
First received: May 22, 2008
Last updated: March 4, 2013
Last verified: March 2013
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: Henry N. Ginsberg, Columbia University
ClinicalTrials.gov Identifier: NCT00683826     History of Changes
Other Study ID Numbers: AAAC6762
Study First Received: May 22, 2008
Results First Received: March 1, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration