Trial Outcomes & Findings for Effects of Fish Oils on Inflammation and Insulin Resistance (NCT NCT00579436)

Last Updated: 2018-05-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

baseline

Results posted on

2018-05-16

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	19	14
Overall Study COMPLETED	19	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Fish Oils on Inflammation and Insulin Resistance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fish Oil Group n=19 Participants 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 n=14 Participants placebo (4 non-active capsules daily) placebo: 4 inert capsules daily by mouth for 12 weeks.	Total n=33 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	53.3 years STANDARD_DEVIATION 8.3 • n=7 Participants	50.8 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants
Weight	99.8 kilograms STANDARD_DEVIATION 12.5 • n=5 Participants	92.1 kilograms STANDARD_DEVIATION 16.9 • n=7 Participants	96.8 kilograms STANDARD_DEVIATION 14.9 • n=5 Participants
Body fat	44.4 percent STANDARD_DEVIATION 7.4 • n=5 Participants	46.2 percent STANDARD_DEVIATION 10.1 • n=7 Participants	44.9 percent STANDARD_DEVIATION 8.64 • n=5 Participants
BMI	33.4 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	33.8 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	33.4 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants
Triglycerides	150 mg/dl STANDARD_DEVIATION 57.92 • n=5 Participants	163.0 mg/dl STANDARD_DEVIATION 82.8 • n=7 Participants	155.7 mg/dl STANDARD_DEVIATION 69 • n=5 Participants
Cholesterol	207.1 mg/dl STANDARD_DEVIATION 41.6 • n=5 Participants	204.7 mg/dl STANDARD_DEVIATION 44.5 • n=7 Participants	206 mg/dl STANDARD_DEVIATION 42.3 • n=5 Participants
High density lipoprotein	53.5 mg/dl STANDARD_DEVIATION 15.21 • n=5 Participants	47.7 mg/dl STANDARD_DEVIATION 12.2 • n=7 Participants	49.50 mg/dl STANDARD_DEVIATION 13.63 • n=5 Participants
Low density lipoprotein	125.9 mg/dl STANDARD_DEVIATION 36.8 • n=5 Participants	122.4 mg/dl STANDARD_DEVIATION 40.8 • n=7 Participants	125.5 mg/dl STANDARD_DEVIATION 37.5 • n=5 Participants
2 hour Glucose	167.8 mg/dl STANDARD_DEVIATION 43.3 • n=5 Participants	157.8 mg/dl STANDARD_DEVIATION 29.0 • n=7 Participants	163.1 mg/dl STANDARD_DEVIATION 37.6 • n=5 Participants
HbA1c	6.0 percent STANDARD_DEVIATION .3 • n=5 Participants	5.6 percent STANDARD_DEVIATION 0.4 • n=7 Participants	5.8 percent STANDARD_DEVIATION .4 • n=5 Participants

PRIMARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Fish Oil Group n=19 Participants 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 n=14 Participants placebo (4 non-active capsules daily) placebo: 4 inert capsules daily by mouth for 12 weeks.
Baseline Adipocyte Size	4958 square micrometers Standard Error 249	4489 square micrometers Standard Error 231

PRIMARY outcome

Timeframe: week 12

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

Outcome measures

Outcome measures
Measure	Fish Oil Group n=19 Participants 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 n=14 Participants placebo (4 non-active capsules daily) placebo: 4 inert capsules daily by mouth for 12 weeks.
Adipocyte Size After Fish Oil Treatment	4869 square micrometers Standard Error 209	4051 square micrometers Standard Error 191

SECONDARY outcome

Timeframe: baseline

Population: all participants were analyzed

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.

Outcome measures

Outcome measures
Measure	Fish Oil Group n=19 Participants 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 n=14 Participants placebo (4 non-active capsules daily) placebo: 4 inert capsules daily by mouth for 12 weeks.
Baseline Insulin Resistance	1.8 [mU/L]^-1 x [min]^-1] Standard Error .2	1.8 [mU/L]^-1 x [min]^-1] Standard Error 0.3

SECONDARY outcome

Timeframe: week 12

Population: all participants measured

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.

Outcome measures

Outcome measures
Measure	Fish Oil Group n=19 Participants 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 n=14 Participants placebo (4 non-active capsules daily) placebo: 4 inert capsules daily by mouth for 12 weeks.
Insulin Resistance After Fish Oil Regiment	1.7 [mU/L]^-1 x [min]^-1] Standard Error .3	1.5 [mU/L]^-1 x [min]^-1] Standard Error 0.2

Adverse Events

Fish Oil Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Phillip Kern

University of Kentucky

Phone: 859 323 4933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place