Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effects of CLA Supplements on Body Weight and Fat Oxidation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204932
First received: September 12, 2005
Last updated: October 1, 2015
Last verified: December 2014
Results First Received: August 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Intervention: Drug: conjugated linoleic acid

  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
Conjugated Linoleic Acid 4 grams per day of 78% CLA for 6 months
Placebo 4 grams per day of sunflower oil for 6 months

Participant Flow:   Overall Study
    Conjugated Linoleic Acid     Placebo  
STARTED     24     24  
COMPLETED     22     18  
NOT COMPLETED     2     6  



  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
Conjugated Linoleic Acid 3 grams per day for 7 months
Placebo 3 grams per day of sunflower oil for 7 months
Total Total of all reporting groups

Baseline Measures
    Conjugated Linoleic Acid     Placebo     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     24     48  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  34  (8)     32  (7)     33  (9)  
Gender  
[units: participants]
     
Female     18     20     38  
Male     6     4     10  
Region of Enrollment  
[units: participants]
     
United States     24     24     48  



  Outcome Measures

1.  Primary:   Fat Mass   [ Time Frame: 6 months ]

2.  Secondary:   Total Fat Oxidation   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dale Schoeller Principal Investigator
Organization: U Wisconsin Madison
phone: 608-262-1082
e-mail: dschoell@nutrisci.wisc.edu


Publications of Results:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204932     History of Changes
Other Study ID Numbers: 2004-0060
Study First Received: September 12, 2005
Results First Received: August 4, 2011
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration