Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
NCT05589064 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-12-13
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.
Conditions
- Brain Injury Traumatic Mild
Interventions
- BEHAVIORAL
-
Experimental: Dietetic counseling
Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.
- DIETARY_SUPPLEMENT
-
Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.
- BEHAVIORAL
-
Other : Physiotherapy treatment
Patients will receive weekly physiotherapy treatment.
Sponsors & Collaborators
-
New Brunswick Health Research Foundation
collaborator OTHER -
Universite de Moncton
lead OTHER
Principal Investigators
-
Stephanie Ward Chiasson, PhD, RD · Universite de Moncton
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-01
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- Canada
Study Locations
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