Fish Oil (Omega 3), Immune Function, and Mood

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University
ClinicalTrials.gov Identifier:
NCT00385723
First received: October 10, 2006
Last updated: November 13, 2012
Last verified: November 2012
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Inflammation
Interventions: Dietary Supplement: Omega 3 (Fish Oil) Supplementation
Dietary Supplement: Placebo

  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
Data collection for this double-blind placebo-controlled four month randomized clinical trial began in September, 2006 and ended in February, 2011. Ohio State University campus and community print and web-based announcements were used for recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We used participants' ability to follow the regimen as a criterion for study entry. Participants received a 7-day supply of placebo capsules (single blind) at the subsequent in-person screening session, and those who had taken less than 80% of the capsules a week later were dropped before randomization.

Reporting Groups
  Description
Placebo Placebo : matching placebo capsule daily for 4 months
1.25 g/d n-3 Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
2.5 g/d n-3 Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months

Participant Flow:   Overall Study
    Placebo     1.25 g/d n-3     2.5 g/d n-3  
STARTED     46     46     46  
COMPLETED     44     45     44  
NOT COMPLETED     2     1     2  
Lost to Follow-up                 1                 1                 0  
Withdrawal by Subject                 1                 0                 2  



  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
Placebo Placebo : matching placebo capsule daily for 4 months
1.25 g/d n-3 Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
2.5 g/d n-3 Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
Total Total of all reporting groups

Baseline Measures
    Placebo     1.25 g/d n-3     2.5 g/d n-3     Total  
Number of Participants  
[units: participants]
  46     46     46     138  
Age  
[units: years]
Mean ± Standard Deviation
  51.1  ± 8.6     51.1  ± 8.0     51.0  ± 6.7     51.0  ± 7.8  
Gender  
[units: participants]
       
Female     36     28     29     93  
Male     10     18     17     45  
Race/Ethnicity, Customized  
[units: participants]
       
White     33     39     37     109  
Black     9     5     8     22  
Asian     2     1     1     4  
Other     2     1     0     3  
Sagittal abdominal diameter  
[units: cm]
Mean ± Standard Deviation
  22.8  ± 3.2     23.9  ± 3.4     22.9  ± 2.9     22.8  ± 3.0  
CES-D [1]
[units: scores on a scale]
Median ( Inter-Quartile Range )
  5  
  ( 3 to 9 )  
  5  
  ( 2 to 11 )  
  6  
  ( 2 to 10 )  
  5  
  ( 2 to 10 )  
[1]

Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.

Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.




  Outcome Measures
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1.  Primary:   Serum ln(TNF-a)   [ Time Frame: Baseline & 4 months ]

2.  Primary:   Serum ln(IL-6)   [ Time Frame: Baseline & 4 months ]

3.  Primary:   ln(CES-D)   [ Time Frame: Baseline & 4 months ]


  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: Dr. Janice K. Kiecolt-Glaser
Organization: Institute for Behavioral Medicine Research, Ohio State University College of Medicine, OH, USA
phone: +1 614 293 3499
e-mail: Janice.Kiecolt-Glaser@osumc.edu


Publications of Results:

Responsible Party: Janice Kiecolt-Glaser, Ohio State University
ClinicalTrials.gov Identifier: NCT00385723     History of Changes
Other Study ID Numbers: AG0087, 2006H0054, R01AG029562
Study First Received: October 10, 2006
Results First Received: August 28, 2012
Last Updated: November 13, 2012
Health Authority: United States: Federal Government