Concussion, MildCONCUSSNCT05847608
Omega-3 Treatment for Concussion in Adolescents
A study testing Omega-3 in people with Concussion, Mild, run by University of Manitoba at 1 site in Canada.
Trial summary
The goal of this clinical trial is to test omega-3 fatty acid supplementation as a treatment in adolescents with a concussion. The main questions it aims to answer are: Does supplementing with omega-3 fatty acids improve time to recovery following sport related concussion. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provide a signed and dated informed consent form;
- State their willingness to comply with all study procedures and availability for the duration of the study;
- Be between 14 and 17 years of age or older;
- Meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 5th Annual Conference of Concussion in Sport, 2017 as determined by the treating physician;
- Present with a sport related concussion within 7 days from injury; and
- Assigned a Glasgow coma scale (GCS) score = 15.
Who cannot join
- Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke;
- Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage or cerebral contusion on previous neuro-imaging studies;
- Pregnant patients;
- Patients with a GCS score less than or equal to 14;
- Patients for whom parental/guardian consent cannot be obtained;
- Patients who have consumed an omega-3 fatty acid containing supplement within the past month;
- Patients with a fish or shell fish allergy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Applied Research Centre, Faculty of Kinesiology, University of Manitoba
Winnipeg, Manitoba, R3T2N2
Stephen Cornish, PhD, 204-474-9981, stephen.cornish@umanitoba.ca
Stephen Cornish, PhD
About this study
Official title: Concussion and Omega-3s - New Consideration for the Therapeutic Use of Nutritional Supplements in Adolescents
The goal of this clinical trial is to test omega-3 fatty acid supplementation as a treatment in adolescents with a concussion. The main questions it aims to answer are:
- Does supplementing with omega-3 fatty acids improve time to recovery following sport related concussion.
- Does supplementing with omega-3 fatty acids improve health related quality of life following concussion.
- Does supplementing with omega-3 fatty acids change post-concussion symptoms following concussion.
- Does supplementing with omega-3 fatty acids change saliva concentrations of interleukin-6 following concussion.
- Does supplementing with omega-3 fatty acids change saliva concentrations of cortisol following concussion.
Participants will be randomized to receive either an omega-3 supplement or placebo after they have been diagnosed with a concussion. Researchers will compare the omega-3 supplement group and placebo group to see if omega-3 fatty acids, consumed as a treatment, can improve time to recovery, health related quality of life and symptom burden, and whether omega-3 fatty acids alter interleukin-6 and cortisol concentrations in saliva following a concussion.
Read the detailed description
Following mild traumatic brain injury, a neurometabolic cascade occurs with concurrent neuronal disruptions, metabolic changes, excitotoxicity, and changes in cerebral blood flow. Omega-3 fatty acids have been postulated as a possible nutritional supplement which could aid in recovery following a concussion. The omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are derived from alpha-linolenic acid (ALA) which is an essential fatty acid. DHA is present at high concentrations in neuronal cells and contributes to the regulation of cell membranes, neurotransmitter release, neurogenesis, and neuroinflammation. EPA is converted to E-series resolvins which act in an anti-inflammatory manner.
Pre-clinical research supports the potential benefits of omega-3 fatty acids following a TBI. There has recently been one pilot study in human adolescents which also supports the need for large randomized controlled trials to fully understand the impact omega-3 fatty acids may have on recovery following concussion. The current evidence suggests that omega-3 supplementation may ameliorate neuroinflammation and neuronal apoptosis, and decrease reactive oxygen species associated with TBI. It has been suggested that following TBI, omega-3 supplementation may improve neural plasticity and signaling related molecules which can improve cognitive function following TBI.
Based on these previous mentioned studies it appears that omega-3 fatty acids could potentially benefit those recovering from a concussion. However, to date there have not been any appropriately powered randomized controlled trials evaluating the efficacy of omega-3 supplementation following sport related concussion.
- Conditions
- Concussion, Mild
- Being tested
- Omega-3, Placebo
- Keywords
- Omega-3
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Daily consumption of 500 mg DHA and 750 mg EPA in liquid form
PlaceboDietary supplement
Also called Olive Oil
Oleic Acid, Linoleic Acid
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Supplementation | Experimental | This groups will supplement their regular diet with 1 tsp of fish oil containing 1.5 grams combined omega-3 fatty acid (EPA/DHA) supplement in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks. Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | This group will supplement their regular diet with 1 tsp olive oil in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery
Time to clinical recovery will be determined by the patients treating physician. This will be defined as: 1) symptoms have returned to baseline or resolved, 2) normal medical examination, 3) tolerating school full-time without symptoms, and 4) tolerating appropriate return to play steps and are cleared to participate in full sport activities.
Measured: Maximum of 6 weeks
Secondary outcomes (5)
Pediatric Quality of Life Inventory (Version 4.0) Teen Report
Participants will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Measured: Maximum of 6 weeks
Pediatric Quality of Life Inventory (Version 4.0) Parents Report
Parent/guardian will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Measured: Maximum of 6 weeks
Sport Concussion Assessment Tool - 5 Symptom Evaluation
Participants will report their symptoms using the post-concussion symptom scale ((PCSS; version from the Sport Concussion Assessment Tool-5) each week until they are determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 132. Higher scores mean worse outcome.
Measured: Maximum of 6 weeks
Interleukin-6
Interleukin-6 will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in inflammatory status.
Measured: Maximum of 6 weeks
Cortisol
Cortisol will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in stress status.
Measured: Maximum of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Cornish, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847608
- Sponsor's protocol ID
- B2023:018
- Acronym
- CONCUSS
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion and Omega-3s - New Consideration for the Therapeutic Use of Nutritional Supplements in Adolescents
- ClinicalTrials.gov ID
- NCT05847608
- Acronym / sponsor ID
- CONCUSS / B2023:018
- Conditions
- Concussion, Mild
- Keywords
- Omega-3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test omega-3 fatty acid supplementation as a treatment in adolescents with a concussion. The main questions it aims to answer are:
- Does supplementing with omega-3 fatty acids improve time to recovery following sport related concussion.
- Does supplementing with omega-3 fatty acids improve health related quality of life following concussion.
- Does supplementing with omega-3 fatty acids change post-concussion symptoms following concussion.
- Does supplementing with omega-3 fatty acids change saliva concentrations of interleukin-6 following concussion.
- Does supplementing with omega-3 fatty acids change saliva concentrations of cortisol following concussion.
Participants will be randomized to receive either an omega-3 supplement or placebo after they have been diagnosed with a concussion. Researchers will compare the omega-3 supplement group and placebo group to see if omega-3 fatty acids, consumed as a treatment, can improve time to recovery, health related quality of life and symptom burden, and whether omega-3 fatty acids alter interleukin-6 and cortisol concentrations in saliva following a concussion.
Detailed description
Following mild traumatic brain injury, a neurometabolic cascade occurs with concurrent neuronal disruptions, metabolic changes, excitotoxicity, and changes in cerebral blood flow. Omega-3 fatty acids have been postulated as a possible nutritional supplement which could aid in recovery following a concussion. The omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are derived from alpha-linolenic acid (ALA) which is an essential fatty acid. DHA is present at high concentrations in neuronal cells and contributes to the regulation of cell membranes, neurotransmitter release, neurogenesis, and neuroinflammation. EPA is converted to E-series resolvins which act in an anti-inflammatory manner.
Pre-clinical research supports the potential benefits of omega-3 fatty acids following a TBI. There has recently been one pilot study in human adolescents which also supports the need for large randomized controlled trials to fully understand the impact omega-3 fatty acids may have on recovery following concussion. The current evidence suggests that omega-3 supplementation may ameliorate neuroinflammation and neuronal apoptosis, and decrease reactive oxygen species associated with TBI. It has been suggested that following TBI, omega-3 supplementation may improve neural plasticity and signaling related molecules which can improve cognitive function following TBI.
Based on these previous mentioned studies it appears that omega-3 fatty acids could potentially benefit those recovering from a concussion. However, to date there have not been any appropriately powered randomized controlled trials evaluating the efficacy of omega-3 supplementation following sport related concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Supplementation | Experimental | Dietary Supplement: Omega-3This groups will supplement their regular diet with 1 tsp of fish oil containing 1.5 grams combined omega-3 fatty acid (EPA/DHA) supplement in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group will supplement their regular diet with 1 tsp olive oil in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Provide a signed and dated informed consent form;
- State their willingness to comply with all study procedures and availability for the duration of the study;
- Be between 14 and 17 years of age or older;
- Meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 5th Annual Conference of Concussion in Sport, 2017 as determined by the treating physician;
- Present with a sport related concussion within 7 days from injury; and
Key exclusion criteria (7 listed)
- Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke;
- Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage or cerebral contusion on previous neuro-imaging studies;
- Pregnant patients;
- Patients with a GCS score less than or equal to 14;
- Patients for whom parental/guardian consent cannot be obtained;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)Daily consumption of 500 mg DHA and 750 mg EPA in liquid form | Dietary supplement | Omega-3 Supplementation |
| PlaceboAlso: Olive OilOleic Acid, Linoleic Acid | Dietary supplement | Placebo |
Primary outcome
Time to clinical recovery
Time frame: Maximum of 6 weeks
Time to clinical recovery will be determined by the patients treating physician. This will be defined as: 1) symptoms have returned to baseline or resolved, 2) normal medical examination, 3) tolerating school full-time without symptoms, and 4) tolerating appropriate return to play steps and are cleared to participate in full sport activities.
5 secondary outcomes
Pediatric Quality of Life Inventory (Version 4.0) Teen Report
Time frame: Maximum of 6 weeks
Pediatric Quality of Life Inventory (Version 4.0) Parents Report
Time frame: Maximum of 6 weeks
Sport Concussion Assessment Tool - 5 Symptom Evaluation
Time frame: Maximum of 6 weeks
Interleukin-6
Time frame: Maximum of 6 weeks
Cortisol
Time frame: Maximum of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Cornish, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Concussion, Mild, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Cornish, PhD (204-474-9981, stephen.cornish@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical recovery (time frame: Maximum of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.