Clinical trial NCT05847608: Omega-3 Treatment for Concussion in Adolescents
Official title: Concussion and Omega-3s - New Consideration for the Therapeutic Use of Nutritional Supplements in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion, Mild
Keywords: Omega-3
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 140
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.
* 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.

Eligibility criteria: Inclusion Criteria:

1. Provide a signed and dated informed consent form;
2. State their willingness to comply with all study procedures and availability for the duration of the study;
3. Be between 14 and 17 years of age or older;
4. 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;
5. Present with a sport related concussion within 7 days from injury; and
6. Assigned a Glasgow coma scale (GCS) score = 15.

Exclusion Criteria:

1. Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke;
2. 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;
3. Pregnant patients;
4. Patients with a GCS score less than or equal to 14;
5. Patients for whom parental/guardian consent cannot be obtained;
6. Patients who have consumed an omega-3 fatty acid containing supplement within the past month;
7. Patients with a fish or shell fish allergy.

Primary outcomes:
measure: Time to clinical recovery
timeFrame: Maximum of 6 weeks
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (Version 4.0) Teen Report
timeFrame: Maximum of 6 weeks
measure: Pediatric Quality of Life Inventory (Version 4.0) Parents Report
timeFrame: Maximum of 6 weeks
measure: Sport Concussion Assessment Tool - 5 Symptom Evaluation
timeFrame: Maximum of 6 weeks
measure: Interleukin-6
timeFrame: Maximum of 6 weeks
measure: Cortisol
timeFrame: Maximum of 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Applied Research Centre, Faculty of Kinesiology, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Stephen Cornish, PhD
role: PRINCIPAL_INVESTIGATOR
References: