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Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00886704
First received: April 21, 2009
Last updated: September 29, 2011
Last verified: July 2009
History of Changes
Results First Received: June 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Atherosclerosis
Interventions: Dietary Supplement: 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)
Dietary Supplement: Control convenience drink

  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
190 subjects were screened and gave informed consent, and 50 were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The main reason for screen failure (about 95 %) was an omega-3 index < 5.0%. Additional subjects were excluded because of the lack of any evidence for atherosclerotic disease, hospitalisation or lactose intolerance.

Reporting Groups
  Description
Convenience Drink With EPA and DHA (Omega-3 Fatty Acids) No text entered.
Convenience Drink Without EPA and DHA No text entered.

Participant Flow:   Overall Study
    Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)     Convenience Drink Without EPA and DHA  
STARTED     40     10  
COMPLETED     40     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Convenience Drink With EPA and DHA (Omega-3 Fatty Acids) No text entered.
Convenience Drink Without EPA and DHA No text entered.
Total Total of all reporting groups

Baseline Measures
    Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)     Convenience Drink Without EPA and DHA     Total  
Number of Participants  
[units: participants]
 		  40     10     50  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     15     5     20  
>=65 years     25     5     30  
Age  
[units: years]
Mean ± Standard Deviation 		  65.1  ± 6.1     64.5  ± 5.9     64.8  ± 6.0  
Gender  
[units: participants]
 		     
Female     11     5     16  
Male     29     5     34  
Region of Enrollment  
[units: participants]
 		     
Germany     40     10     50  



  Outcome Measures
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1.  Primary:   Omega-3 Index   [ Time Frame: after eight weeks of intervention ]
  Show Outcome Measure 1

2.  Secondary:   Palatability   [ Time Frame: at 8 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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 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.


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
Single center study, too small to detect rare side effects, 8 week intervention period relatively short.  


Results Point of Contact:  
Name/Title: Clemens von Schacky, Head, Preventive Cardiology, University of Munich
Organization: Ludwig Maximilians-University Munich
phone: +498951600 ext 2165
e-mail: clemens.vonschacky@med.uni-muenchen.de


Publications of Results:


Responsible Party: Clemens von Schacky, Preventive Cardiology, University of Munich
ClinicalTrials.gov Identifier: NCT00886704     History of Changes
Other Study ID Numbers: 477-08
Study First Received: April 21, 2009
Results First Received: June 15, 2011
Last Updated: September 29, 2011
Health Authority: Germany: Ethics Commission