Trial Outcomes & Findings for Fish Oils and Adipose Inflammation Reduction (NCT NCT02010359)
NCT ID: NCT02010359
Last Updated: 2019-02-12
Results Overview
Quantification of fractalkine levels in plasma at baseline and after 8 weeks of Lovaza or placebo will be compared.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
Lovaza
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fish Oils and Adipose Inflammation Reduction
Baseline characteristics by cohort
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
BMI
|
36.1 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
35.9 kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
36 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
fasting glucose
|
86.4 mg/dl
STANDARD_DEVIATION 11.6 • n=5 Participants
|
87.8 mg/dl
STANDARD_DEVIATION 10.2 • n=7 Participants
|
87.1 mg/dl
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
fasting triglyceride
|
138.8 mg/dl
STANDARD_DEVIATION 107.6 • n=5 Participants
|
92.9 mg/dl
STANDARD_DEVIATION 35.1 • n=7 Participants
|
116.8 mg/dl
STANDARD_DEVIATION 83.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksQuantification of fractalkine levels in plasma at baseline and after 8 weeks of Lovaza or placebo will be compared.
Outcome measures
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in Plasma Fractalkine Levels
baseline
|
0.42 ng/ml
Standard Deviation 0.1
|
0.46 ng/ml
Standard Deviation 0.1
|
|
Change in Plasma Fractalkine Levels
8 weeks
|
0.48 ng/ml
Standard Deviation 0.1
|
0.45 ng/ml
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksQuantification of plasma IL-6 at baseline and after 8 weeks of Lovaza/placebo will be compared.
Outcome measures
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in Plasma Interleukin 6 (IL-6)
baseline
|
2.1 pg/ml
Standard Deviation 1.6
|
1.8 pg/ml
Standard Deviation 2.0
|
|
Change in Plasma Interleukin 6 (IL-6)
8 weeks
|
2.0 pg/ml
Standard Deviation 1.5
|
2.0 pg/ml
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksQuantification of plasma MCP-1 at baseline and after 8 weeks of Lovaza/placebo will be compared
Outcome measures
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in Plasma Monocyte Chemotactic Protein-1 (MCP-1)
baseline
|
135 pg/ml
Standard Deviation 15.8
|
139 pg/ml
Standard Deviation 30.8
|
|
Change in Plasma Monocyte Chemotactic Protein-1 (MCP-1)
8 weeks
|
133 pg/ml
Standard Deviation 29.1
|
123 pg/ml
Standard Deviation 54.1
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksQuantification of plasma TNFalpha at baseline and after 8 weeks of Lovaza/placebo will be compared
Outcome measures
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in Plasma Tumor Necrosis Factor Alpha (TNFalpha)
baseline
|
0.72 pg/ml
Standard Deviation 0.51
|
0.74 pg/ml
Standard Deviation 0.23
|
|
Change in Plasma Tumor Necrosis Factor Alpha (TNFalpha)
8 weeks
|
0.76 pg/ml
Standard Deviation 0.21
|
0.74 pg/ml
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: baseline and 8 weeksRatio of inflammatory CX3CR1lowCCR2+ to less inflammatory CX3CR1hiCCR2- monocytes by flow cytometry at baseline and after 8 weeks of Lovaza/placebo will be compared
Outcome measures
| Measure |
Lovaza
n=13 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in the Ratio of Circulating Monocyte Subpopulations
baseline
|
0.31 ratio
Standard Deviation 0.11
|
0.35 ratio
Standard Deviation 0.15
|
|
Change in the Ratio of Circulating Monocyte Subpopulations
8 weeks
|
0.25 ratio
Standard Deviation 0.1
|
0.31 ratio
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: There were 4 participants that did not have sufficient adipose tissue in the biopsy for RT-PCR
relative mRNA quantification (fold change) from baseline to 8 weeks of Lovaza/placebo will be compared in each subject
Outcome measures
| Measure |
Lovaza
n=10 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=11 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in mRNA Expression of Fractalkine in Adipose
|
1.67 fold change
Standard Deviation 1.1
|
1.06 fold change
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: 4 participants did not have sufficient adipose tissue in biopsy for RT-PCR
relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR
Outcome measures
| Measure |
Lovaza
n=10 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=11 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in mRNA Levels of MCP-1 in Adipose
|
1.2 fold change
Standard Deviation 0.7
|
1.05 fold change
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: 4 participants did not have sufficient adipose tissue from biopsy for RT PCR
relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR
Outcome measures
| Measure |
Lovaza
n=10 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=11 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in mRNA Levels of IL6 in Adipose
|
0.91 fold change
Standard Deviation 1.1
|
1.08 fold change
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: 4 subjects did not have sufficient adipose tissue from biopsy for RT-PCR
relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR
Outcome measures
| Measure |
Lovaza
n=10 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=11 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in mRNA Levels of TNFalpha in Adipose
|
1.2 fold change
Standard Deviation 3.8
|
2.5 fold change
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: 4 participants did not sufficient adipose tissue from biopsy for flow cytometry analysis
Ratio of M1 to M2 macrophages in adipose by flow cytometry at baseline and after 8 weeks Lovaza/placebo will be compared
Outcome measures
| Measure |
Lovaza
n=10 Participants
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=11 Participants
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Change in Ratio of Adipose Tissue Macrophage Subpopulation
baseline
|
0.52 ratio
Standard Deviation 0.3
|
0.64 ratio
Standard Deviation 0.42
|
|
Change in Ratio of Adipose Tissue Macrophage Subpopulation
8 weeks
|
0.36 ratio
Standard Deviation 0.52
|
0.42 ratio
Standard Deviation 0.38
|
Adverse Events
Lovaza
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lovaza
n=13 participants at risk
Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks
Lovaza
|
Placebo
n=12 participants at risk
An inactive Placebo (2 pills twice daily) will be given for 8 weeks
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Skiing accident
|
0.00%
0/13 • 2 months
|
8.3%
1/12 • Number of events 1 • 2 months
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 2 • 2 months
|
8.3%
1/12 • Number of events 3 • 2 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • 2 months
|
8.3%
1/12 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/13 • 2 months
|
8.3%
1/12 • Number of events 1 • 2 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
7.7%
1/13 • Number of events 1 • 2 months
|
0.00%
0/12 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place