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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
Enrollment 33

Recruitment Details 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  
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description

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

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

placebo (4 non-active capsules daily)

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

Period Title: Overall Study
Started 19 14
Completed 19 14
Not Completed 0 0
Arm/Group Title Fish Oil Group Control Group Total
Hide Arm/Group Description

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

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

placebo (4 non-active capsules daily)

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

Total of all reporting groups
Overall Number of Baseline Participants 19 14 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 14 participants 33 participants
48.8  (9.8) 53.3  (8.3) 50.8  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
Female
13
  68.4%
9
  64.3%
22
  66.7%
Male
6
  31.6%
5
  35.7%
11
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 14 participants 33 participants
19 14 33
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 19 participants 14 participants 33 participants
99.8  (12.5) 92.1  (16.9) 96.8  (14.9)
Body fat  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 19 participants 14 participants 33 participants
44.4  (7.4) 46.2  (10.1) 44.9  (8.64)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 14 participants 33 participants
33.4  (5.4) 33.8  (4.3) 33.4  (4.9)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 19 participants 14 participants 33 participants
150  (57.92) 163.0  (82.8) 155.7  (69)
Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 19 participants 14 participants 33 participants
207.1  (41.6) 204.7  (44.5) 206  (42.3)
High density lipoprotein  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 19 participants 14 participants 33 participants
53.5  (15.21) 47.7  (12.2) 49.50  (13.63)
Low density lipoprotein  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 19 participants 14 participants 33 participants
125.9  (36.8) 122.4  (40.8) 125.5  (37.5)
2 hour Glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 19 participants 14 participants 33 participants
167.8  (43.3) 157.8  (29.0) 163.1  (37.6)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 19 participants 14 participants 33 participants
6.0  (.3) 5.6  (0.4) 5.8  (.4)
1.Primary Outcome
Title Baseline Adipocyte Size
Hide Description Prior to starting the fish oil regiment, participants will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine adipocyte size
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description:

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

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

placebo (4 non-active capsules daily)

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

Overall Number of Participants Analyzed 19 14
Mean (Standard Error)
Unit of Measure: square micrometers
4958  (249) 4489  (231)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Adipocyte Size After Fish Oil Treatment
Hide Description After completing the fish oil regiment, participant will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine individual adipocyte size
Time Frame week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description:

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

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

placebo (4 non-active capsules daily)

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

Overall Number of Participants Analyzed 19 14
Mean (Standard Error)
Unit of Measure: square micrometers
4869  (209) 4051  (191)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Baseline Insulin Resistance
Hide Description Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose levels were plotted on a time course curve and analyzed using the MIDMOD algorithm.
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants were analyzed
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description:

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

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

placebo (4 non-active capsules daily)

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

Overall Number of Participants Analyzed 19 14
Mean (Standard Error)
Unit of Measure: [mU/L]^-1 x [min]^-1]
1.8  (.2) 1.8  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Insulin Resistance After Fish Oil Regiment
Hide Description Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose and Insulin levels will be plotted on a time course curve and analyzed using the MINMOD algorithm.
Time Frame week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants measured
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description:

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

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

placebo (4 non-active capsules daily)

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

Overall Number of Participants Analyzed 19 14
Mean (Standard Error)
Unit of Measure: [mU/L]^-1 x [min]^-1]
1.7  (.3) 1.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fish Oil Group Control Group
Hide Arm/Group Description

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

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

placebo (4 non-active capsules daily)

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

All-Cause Mortality
Fish Oil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fish Oil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fish Oil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Study not being powered to identify a difference between groups
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
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