NCT05589064 Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
| NCT ID | NCT05589064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universite de Moncton |
| Condition | Brain Injury Traumatic Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-10-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms. This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.
Eligibility Criteria
Inclusion Criteria: * 16 years or older * Must be able to understand English or French * Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months Exclusion Criteria: * \<16 years old * People who are breastfeeding, pregnant or plan to become pregnant in the next 2 months * People with neurological disorders (other than concussion) or a history of moderate or severe brain injury * People in an acute phase of an inflammatory bowel disease * Any physical condition prohibiting a patient from receiving physiotherapy treatments
Contact & Investigator
Stephanie Ward Chiasson, PhD, RD
PRINCIPAL INVESTIGATOR
Universite de Moncton
Frequently Asked Questions
Who can join the NCT05589064 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Brain Injury Traumatic Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05589064 currently recruiting?
Yes, NCT05589064 is actively recruiting participants. Contact the research team at stephanie.ward@umoncton.ca for enrollment information.
Where is the NCT05589064 trial being conducted?
This trial is being conducted at Moncton, Canada.
Who is sponsoring the NCT05589064 clinical trial?
NCT05589064 is sponsored by Universite de Moncton. The principal investigator is Stephanie Ward Chiasson, PhD, RD at Universite de Moncton. The trial plans to enroll 120 participants.