Clinical trial NCT05589064: Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
Official title: Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injury Traumatic Mild
Keywords: Dietary intervention
Supplements
Omega-3
Vitamin D
Creatine monohydrate
Lead sponsor: Universite de Moncton
Sponsor class: OTHER
Collaborators: name: New Brunswick Health Research Foundation
First posted: 2022-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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. Some studies have explored the impact of pharmaceuticals on treating post-concussive symptoms. Still, these have shown little success, leading the scientific community to consider multidisciplinary approaches to treating and managing concussions. Recently, it has been suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. Some nutritional supplements have shown beneficial effects on the speed of recovery and the degree of severity of symptoms related to moderate or severe head trauma. Other studies have shown a link between malnutrition and low neurological and cognitive scores. 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. The use of three groups will help determine the individual impact of dietetic treatment offered by a dietitian and the use of supplements. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice by medical doctors, physiotherapists and dietitians. 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

Primary outcomes:
measure: Change from baseline in severity of post-concussive symptoms at the end of the intervention
timeFrame: Baseline and Endpoint (Week 8)
Secondary outcomes:
measure: Change from baseline in balance at the end of the intervention
timeFrame: Baseline and Endpoint (Week 8)
measure: Change from baseline in vestibular ocular motor at the end of the intervention
timeFrame: Baseline and Endpoint (Week 8)
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Universite de Moncton
state: New Brunswick
Study officials:
affiliation: Universite de Moncton
name: Stephanie Ward Chiasson, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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