Trial Outcomes & Findings for Fish Oil (Omega 3), Immune Function, and Mood (NCT NCT00385723)
NCT ID: NCT00385723
Last Updated: 2012-11-20
Results Overview
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
Baseline & 4 months
Results posted on
2012-11-20
Participant Flow
Data collection for this double-blind placebo-controlled four month randomized clinical trial began in September, 2006 and ended in February, 2011. Ohio State University campus and community print and web-based announcements were used for recruitment.
We used participants' ability to follow the regimen as a criterion for study entry. Participants received a 7-day supply of placebo capsules (single blind) at the subsequent in-person screening session, and those who had taken less than 80% of the capsules a week later were dropped before randomization.
Participant milestones
| Measure |
Placebo
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
46
|
|
Overall Study
COMPLETED
|
44
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
Baseline Characteristics
Fish Oil (Omega 3), Immune Function, and Mood
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
51.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=5 Participants
|
39 participants
n=7 Participants
|
37 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Sagittal abdominal diameter
|
22.8 cm
STANDARD_DEVIATION 3.2 • n=5 Participants
|
23.9 cm
STANDARD_DEVIATION 3.4 • n=7 Participants
|
22.9 cm
STANDARD_DEVIATION 2.9 • n=5 Participants
|
22.8 cm
STANDARD_DEVIATION 3.0 • n=4 Participants
|
|
CES-D
|
5 scores on a scale
n=5 Participants
|
5 scores on a scale
n=7 Participants
|
6 scores on a scale
n=5 Participants
|
5 scores on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline & 4 monthsPopulation: intention to treat
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
Serum ln(TNF-a)
Baseline (visit 1)
|
0.66 pg/ml (raw TNF-a)
Standard Error 0.25
|
0.74 pg/ml (raw TNF-a)
Standard Error 0.25
|
0.71 pg/ml (raw TNF-a)
Standard Error 0.25
|
|
Serum ln(TNF-a)
Change, Visit 1 to 5
|
0.11 pg/ml (raw TNF-a)
Standard Error 0.030
|
0.002 pg/ml (raw TNF-a)
Standard Error 0.028
|
-0.024 pg/ml (raw TNF-a)
Standard Error 0.029
|
PRIMARY outcome
Timeframe: Baseline & 4 monthsPopulation: intention to treat
log-transformed serum Interleukin-6 (IL-6)
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
Serum ln(IL-6)
Baseline (visit 1)
|
0.91 pg/ml (raw IL-6)
Standard Error 0.60
|
1.02 pg/ml (raw IL-6)
Standard Error 0.60
|
0.85 pg/ml (raw IL-6)
Standard Error 0.60
|
|
Serum ln(IL-6)
Change, Visit 1 to 5
|
0.31 pg/ml (raw IL-6)
Standard Error 0.077
|
-0.106 pg/ml (raw IL-6)
Standard Error 0.070
|
-0.123 pg/ml (raw IL-6)
Standard Error 0.074
|
PRIMARY outcome
Timeframe: Baseline & 4 monthsPopulation: 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=46 Participants
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
n=46 Participants
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
ln(CES-D)
Baseline (visit 1)
|
1.5 scores on a scale
Standard Error 0.17
|
1.5 scores on a scale
Standard Error 0.17
|
1.6 scores on a scale
Standard Error 0.17
|
|
ln(CES-D)
Change, visit 1 to 5
|
-0.056 scores on a scale
Standard Error 0.15
|
-0.29 scores on a scale
Standard Error 0.15
|
-0.26 scores on a scale
Standard Error 0.15
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
1.25 g/d n-3
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
2.5 g/d n-3
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Placebo : matching placebo capsule daily for 4 months
|
1.25 g/d n-3
n=46 participants at risk
Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
|
2.5 g/d n-3
n=46 participants at risk
Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Ear ache
|
13.0%
6/46 • Number of events 6 • 4 months
|
8.7%
4/46 • Number of events 4 • 4 months
|
4.3%
2/46 • Number of events 2 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.5%
3/46 • Number of events 3 • 4 months
|
21.7%
10/46 • Number of events 10 • 4 months
|
17.4%
8/46 • Number of events 8 • 4 months
|
|
Blood and lymphatic system disorders
Swollen glands
|
2.2%
1/46 • Number of events 1 • 4 months
|
0.00%
0/46 • 4 months
|
2.2%
1/46 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
39.1%
18/46 • Number of events 18 • 4 months
|
43.5%
20/46 • Number of events 20 • 4 months
|
50.0%
23/46 • Number of events 23 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
6.5%
3/46 • Number of events 3 • 4 months
|
2.2%
1/46 • Number of events 1 • 4 months
|
4.3%
2/46 • Number of events 2 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
21.7%
10/46 • Number of events 10 • 4 months
|
21.7%
10/46 • Number of events 10 • 4 months
|
13.0%
6/46 • Number of events 6 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Wet cough
|
17.4%
8/46 • Number of events 8 • 4 months
|
13.0%
6/46 • Number of events 6 • 4 months
|
13.0%
6/46 • Number of events 6 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
15.2%
7/46 • Number of events 7 • 4 months
|
13.0%
6/46 • Number of events 6 • 4 months
|
17.4%
8/46 • Number of events 8 • 4 months
|
|
Gastrointestinal disorders
Stomach pain
|
26.1%
12/46 • Number of events 12 • 4 months
|
28.3%
13/46 • Number of events 13 • 4 months
|
30.4%
14/46 • Number of events 14 • 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
10/46 • Number of events 10 • 4 months
|
15.2%
7/46 • Number of events 7 • 4 months
|
26.1%
12/46 • Number of events 12 • 4 months
|
Additional Information
Dr. Janice K. Kiecolt-Glaser
Institute for Behavioral Medicine Research, Ohio State University College of Medicine, OH, USA
Phone: +1 614 293 3499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place