NCT05847608

Omega-3 Treatment for Concussion in Adolescents

Concussion and Omega-3s - New Consideration for the Therapeutic Use of Nutritional Supplements in Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Concussion, Mild

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	Daily consumption of 500 mg DHA and 750 mg EPA in liquid form
DIETARY_SUPPLEMENT	Placebo	Oleic Acid, Linoleic Acid

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-05-06
• Last updated: 2023-06-23

Locations

1 site across 1 country: Canada