Trial Outcomes & Findings for The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes (NCT NCT04796207)
NCT ID: NCT04796207
Last Updated: 2025-05-09
Results Overview
This primary outcome covers the change in the plasma brain biomarker Neurofilament Light Chains (Nf-L) due to sub-concussion injury from baseline to predetermined measurement time points. Nf-L (neuron specific intermediate proteins) are released upon injury to neurons and axons. Measured in picograms per milliliter (pg/ml)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline, Week 17, Week 26
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Fish Oil Capsules
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Fish Oil Capsules
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
Baseline Characteristics
The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes
Baseline characteristics by cohort
| Measure |
Fish Oil Capsules
n=19 Participants
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
n=19 Participants
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Total
n=38 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
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 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
|
20.9 years
STANDARD_DEVIATION 0.70 • n=99 Participants
|
21.2 years
STANDARD_DEVIATION 2.07 • n=107 Participants
|
21.05 years
STANDARD_DEVIATION 1.74 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 17, Week 26This primary outcome covers the change in the plasma brain biomarker Neurofilament Light Chains (Nf-L) due to sub-concussion injury from baseline to predetermined measurement time points. Nf-L (neuron specific intermediate proteins) are released upon injury to neurons and axons. Measured in picograms per milliliter (pg/ml)
Outcome measures
| Measure |
Fish Oil Capsules
n=12 Participants
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
n=17 Participants
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L
Baseline
|
5.36 pg/ml
Interval 4.71 to 6.0
|
4.82 pg/ml
Interval 4.54 to 5.1
|
|
Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L
Week 17
|
6.05 pg/ml
Interval 5.65 to 6.44
|
6.47 pg/ml
Interval 6.14 to 6.8
|
|
Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L
Week 26
|
7.61 pg/ml
Interval 6.54 to 8.69
|
6.21 pg/ml
Interval 5.86 to 6.57
|
PRIMARY outcome
Timeframe: Baseline ans Week 26This primary outcome covers the change in the plasma inflammation biomarker Tumor Necrosis Factor-alpha (TNF-α), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. TNF-α is measured in picograms per milliliter (pg/ml).
Outcome measures
| Measure |
Fish Oil Capsules
n=12 Participants
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
n=17 Participants
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Changes in Sub-concussion Injury Related Inflammation Biomarkers - TNF-α
Baseline
|
1.181 pg/ml
Interval 1.02 to 1.34
|
0.962 pg/ml
Interval 0.91 to 1.01
|
|
Changes in Sub-concussion Injury Related Inflammation Biomarkers - TNF-α
Week 26
|
1.039 pg/ml
Interval 0.86 to 1.22
|
0.918 pg/ml
Interval 0.88 to 0.96
|
PRIMARY outcome
Timeframe: Baseline; Week 17; Week 26This primary outcome covers the change in the plasma inflammation biomarker Interleukin-6 (IL-6), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. IL-6 is measured in picograms per milliliter (pg/ml)
Outcome measures
| Measure |
Fish Oil Capsules
n=12 Participants
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
n=17 Participants
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6
Baseline
|
2.186 pg/ml
Interval 1.71 to 2.66
|
1.309 pg/ml
Interval 1.12 to 1.5
|
|
Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6
Week 17
|
2.338 pg/ml
Interval 1.77 to 2.9
|
2.107 pg/ml
Interval 1.71 to 2.5
|
|
Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6
Week 26
|
2.158 pg/ml
Interval 1.52 to 2.79
|
1.761 pg/ml
Interval 1.53 to 1.99
|
Adverse Events
Fish Oil Capsules
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Safflower Oil Capsules
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fish Oil Capsules
n=12 participants at risk
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.
Fish Oil (DPA+EPA 2:1 ratio) Capsules: The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
Safflower Oil Capsules
n=17 participants at risk
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.
High Oleic Safflower Oil Capsules: The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 5 times a week during the regular football season.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
25.0%
3/12 • Number of events 3 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
52.9%
9/17 • Number of events 9 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
2/12 • Number of events 2 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
5.9%
1/17 • Number of events 1 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
|
Gastrointestinal disorders
GI distress
|
25.0%
3/12 • Number of events 3 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
0.00%
0/17 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
|
Gastrointestinal disorders
Halitosis
|
33.3%
4/12 • Number of events 4 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
0.00%
0/17 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
|
Nervous system disorders
Concussion
|
16.7%
2/12 • Number of events 2 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
5.9%
1/17 • Number of events 1 • 6 months
Adverse events were reported to study staff daily when supplements were delivered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place