Omega-3 Treatment for Concussion in Adolescents

NCT ID: NCT05847608

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-12-31

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.

Conditions

Concussion, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Omega-3 Supplementation

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.

Group Type: EXPERIMENTAL

Omega-3

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of 500 mg DHA and 750 mg EPA in liquid form

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oleic Acid, Linoleic Acid

Interventions

Omega-3

Daily consumption of 500 mg DHA and 750 mg EPA in liquid form

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oleic Acid, Linoleic Acid

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); Olive Oil

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Cornish, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Central Contacts

Stephen Cornish, PhD

Role: CONTACT

stephen.cornish@umanitoba.ca

204-474-9981

Dean Cordingley, MSc

Role: CONTACT

umcordid@myumanitoba.ca

204-926-5858

Facility Contacts

Stephen Cornish, PhD

Role: primary

stephen.cornish@umanitoba.ca

204-474-9981

Other Identifiers

B2023:018

Identifier Type: -

Identifier Source: org_study_id