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Effects of Fish Oils on Inflammation and Insulin Resistance

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ClinicalTrials.gov Identifier: NCT00579436
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Philip Kern, University of Kentucky

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Metabolic Syndrome
Insulin Resistance
Interventions: Drug: omega-3 fatty acid
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Non-diabetic subjects with either impaired glucose tolerance, impaired fasting glucose, or at least three features of metabolic syndrome were recruited at the University of Kentucky or the University of Arkansas. Exclusion criteria included history of coronary heart disease, inflammatory disease or chronic anti-inflammatory use

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
Fish Oil Group

4g Lovaza (omega-3 fatty acid) daily.

omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks.

Control Group

placebo (4 non-active capsules daily)

placebo: 4 inert capsules daily by mouth for 12 weeks.


Participant Flow:   Overall Study
    Fish Oil Group   Control Group
STARTED   19   14 
COMPLETED   19   14 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Fish Oil Group

4g Lovaza (omega-3 fatty acid) daily.

omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks.

Control Group

placebo (4 non-active capsules daily)

placebo: 4 inert capsules daily by mouth for 12 weeks.

Total Total of all reporting groups

Baseline Measures
   Fish Oil Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   14   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (9.8)   53.3  (8.3)   50.8  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  68.4%      9  64.3%      22  66.7% 
Male      6  31.6%      5  35.7%      11  33.3% 
Region of Enrollment 
[Units: Participants]
     
United States   19   14   33 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 99.8  (12.5)   92.1  (16.9)   96.8  (14.9) 
Body fat 
[Units: Percent]
Mean (Standard Deviation)
 44.4  (7.4)   46.2  (10.1)   44.9  (8.64) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 33.4  (5.4)   33.8  (4.3)   33.4  (4.9) 
Triglycerides 
[Units: Mg/dl]
Mean (Standard Deviation)
 150  (57.92)   163.0  (82.8)   155.7  (69) 
Cholesterol 
[Units: Mg/dl]
Mean (Standard Deviation)
 207.1  (41.6)   204.7  (44.5)   206  (42.3) 
High density lipoprotein 
[Units: Mg/dl]
Mean (Standard Deviation)
 53.5  (15.21)   47.7  (12.2)   49.50  (13.63) 
Low density lipoprotein 
[Units: Mg/dl]
Mean (Standard Deviation)
 125.9  (36.8)   122.4  (40.8)   125.5  (37.5) 
2 hour Glucose 
[Units: Mg/dl]
Mean (Standard Deviation)
 167.8  (43.3)   157.8  (29.0)   163.1  (37.6) 
HbA1c 
[Units: Percent]
Mean (Standard Deviation)
 6.0  (.3)   5.6  (0.4)   5.8  (.4) 


  Outcome Measures

1.  Primary:   Baseline Adipocyte Size   [ Time Frame: baseline ]

2.  Primary:   Adipocyte Size After Fish Oil Treatment   [ Time Frame: week 12 ]

3.  Secondary:   Baseline Insulin Resistance   [ Time Frame: baseline ]

4.  Secondary:   Insulin Resistance After Fish Oil Regiment   [ Time Frame: week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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
Study not being powered to identify a difference between groups


  More Information

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


Results Point of Contact:  
Name/Title: Phillip Kern
Organization: University of Kentucky
phone: 859 323 4933
e-mail: pake2222@uky.edu


Publications of Results:

Responsible Party: Philip Kern, University of Kentucky
ClinicalTrials.gov Identifier: NCT00579436     History of Changes
Other Study ID Numbers: 74457
P20RR021954 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2007
First Posted: December 24, 2007
Results First Submitted: February 13, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018