Trial Outcomes & Findings for Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation (NCT NCT01813110)
NCT ID: NCT01813110
Last Updated: 2023-08-21
Results Overview
Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention
COMPLETED
NA
21 participants
24 hours post endotoxin administration, following each 8 week intervention
2023-08-21
Participant Flow
A balanced randomization scheme was developed in advance, and subjects were assigned to a treatment sequence at enrollment.
Participant milestones
| Measure |
Placebo (8 Weeks), Then Omega-3 Fatty Acids (8 Weeks)
8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate)
|
Omega-3 Fatty Acids (8 Weeks), Then Placebo (8 Weeks)
8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation
Baseline characteristics by cohort
| Measure |
Baseline
n=20 Participants
Baseline (prior to placebo or omega-3 supplementation)
|
|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 hours post endotoxin administration, following each 8 week interventionChange in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention
Outcome measures
| Measure |
Placebo (8 Weeks)
n=20 Participants
8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
|
Omega-3 Fatty Acids (8 Weeks)
n=20 Participants
8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
|
|---|---|---|
|
Change in C Reactive Protein (CRP)
|
17.2 mg/L
Standard Error 1.8
|
17.1 mg/L
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 2 hours post endotoxin administration, following each 8 week interventionChange in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention
Outcome measures
| Measure |
Placebo (8 Weeks)
n=20 Participants
8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
|
Omega-3 Fatty Acids (8 Weeks)
n=20 Participants
8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
|
|---|---|---|
|
Tumor Necrosis Factor-α (TNF-α)
|
58.3 pg/mL
Standard Error 8.1
|
59.9 pg/mL
Standard Error 8.1
|
SECONDARY outcome
Timeframe: 2 hours post endotoxin administration, following each 8 week interventionChange in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention
Outcome measures
| Measure |
Placebo (8 Weeks)
n=20 Participants
8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
|
Omega-3 Fatty Acids (8 Weeks)
n=20 Participants
8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
|
|---|---|---|
|
Interleukin-6 (IL-6)
|
90.6 pg/mL
Standard Error 14.0
|
99.9 pg/mL
Standard Error 14.0
|
Adverse Events
Placebo, Omega-3
Omega-3, Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place