Trial Outcomes & Findings for Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention (NCT NCT00519779)
NCT ID: NCT00519779
Last Updated: 2012-03-27
Results Overview
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
COMPLETED
PHASE2
68 participants
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
2012-03-27
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
23.4 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
23.9 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
23.6 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
34 participants
n=107 Participants
|
68 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intention to treat
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Serum ln(IL-6)
|
0.054 ln(pg/mL)
Standard Error 0.070
|
0.051 ln(pg/mL)
Standard Error 0.069
|
PRIMARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intention to treat
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Serum ln(TNF-a)
|
0.61 ln(pg/mL)
Standard Error 0.028
|
0.54 ln(pg/mL)
Standard Error 0.027
|
PRIMARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intent to treat
log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Stimulated ln(IL-6)
|
11.1 ln(pg/mL)
Standard Error 0.051
|
10.9 ln(pg/mL)
Standard Error 0.050
|
PRIMARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intention to treat
log-transformed stimulated TNF-alpha
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Stimulated ln(TNF-alpha)
|
7.4 ln(pg/mL)
Standard Error 0.061
|
7.3 ln(pg/mL)
Standard Error 0.060
|
SECONDARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intention to treat
log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
ln(Beck Anxiety Score)
|
1.2 units
Standard Error 0.075
|
0.93 units
Standard Error 0.076
|
SECONDARY outcome
Timeframe: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)Population: intention to treat
log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 Participants
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
ln(CES-D)
|
1.6 scores on a
Standard Error 0.097
|
1.6 scores on a
Standard Error 0.098
|
Adverse Events
Placebo
Omega-3 Fish Oil Supplement
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Placebo oral Omega-3 fish oil supplementation
|
Omega-3 Fish Oil Supplement
n=34 participants at risk
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\])
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
23.5%
8/34 • Number of events 8 • 3 months
|
23.5%
8/34 • Number of events 8 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal symptoms
|
17.6%
6/34 • Number of events 6 • 3 months
|
20.6%
7/34 • Number of events 7 • 3 months
|
|
Gastrointestinal disorders
Stomach pain
|
14.7%
5/34 • Number of events 5 • 3 months
|
17.6%
6/34 • Number of events 6 • 3 months
|
|
Cardiac disorders
Tachycardia
|
17.6%
6/34 • Number of events 6 • 3 months
|
14.7%
5/34 • Number of events 5 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.8%
3/34 • Number of events 3 • 3 months
|
11.8%
4/34 • Number of events 4 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
14.7%
5/34 • Number of events 5 • 3 months
|
5.9%
2/34 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • 3 months
|
11.8%
4/34 • Number of events 4 • 3 months
|
|
Cardiac disorders
Heartburn
|
11.8%
4/34 • Number of events 4 • 3 months
|
5.9%
2/34 • Number of events 2 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place