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Clinical Trials/NCT05589064
NCT05589064RecruitingNot Applicable

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

Universite de Moncton1 site in 1 country120 target enrollmentStarted: October 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Change from baseline in severity of post-concussive symptoms at the end of the intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dietary intervention and nutritional supplements (group A)

Experimental

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 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements prescribed by their doctor.

Intervention: Experimental: Dietetic counseling (Behavioral)

Dietary intervention and nutritional supplements (group A)

Experimental

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 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements prescribed by their doctor.

Intervention: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate (Dietary Supplement)

Dietary intervention and nutritional supplements (group A)

Experimental

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 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements prescribed by their doctor.

Intervention: Other : Physiotherapy treatment (Behavioral)

Nutritional supplements (group B)

Active Comparator

Patients in group B will be prescribed omega-3 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements and receive physiotherapy treatments over eight weeks.

Intervention: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate (Dietary Supplement)

Nutritional supplements (group B)

Active Comparator

Patients in group B will be prescribed omega-3 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements and receive physiotherapy treatments over eight weeks.

Intervention: Other : Physiotherapy treatment (Behavioral)

Physiotherapy treatment (control group)

Other

Patients in the control group will receive physiotherapy treatments over eight weeks.

Intervention: Other : Physiotherapy treatment (Behavioral)

Outcomes

Primary Outcomes

Change from baseline in severity of post-concussive symptoms at the end of the intervention

Time Frame: Baseline and Endpoint (Week 8)

Patients' severity of post-concussive symptoms will be measured using the 5th edition of the Sport Concussion Assessment Tool (SCAT5). This tool assesses the degree of severity of 22 concussion-related symptoms, on a scale of 0 (no symptoms) to 6 (severe). The total number of perceived symptoms is noted by the physiotherapist, and a symptom severity score is calculated (scale from 0 to 132 points).

Secondary Outcomes

  • Change from baseline in balance at the end of the intervention(Baseline and Endpoint (Week 8))
  • Change from baseline in vestibular ocular motor at the end of the intervention(Baseline and Endpoint (Week 8))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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