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NCT Number: NCT05589064

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Dietetic counseling

Behavioral

Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.

Active Comparator: Omega-3, vitamin D3 and creatine monohydrate

Dietary Supplement

Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.

Other : Physiotherapy treatment

Behavioral

Patients will receive weekly physiotherapy treatment.

Primary outcomes

  1. 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

  1. Change from baseline in balance at the end of the intervention

    Time frame: Baseline and Endpoint (Week 8)

    The physiotherapist will assess patients' balance using the Modified Balance Error Scoring System (mBESS) test. This objective and validated tool is complimentary to the SCAT5 and is scored from 0 to 30 points, where a greater score indicates severe balance impairment.

  2. Change from baseline in vestibular ocular motor at the end of the intervention

    Time frame: Baseline and Endpoint (Week 8)

    The physiotherapist will assess patients' vestibular ocular motor using the Vestibular Ocular Screening (VOMS) test (Mucha et al., 2014). This tool measures five domains, including smooth pursuits, saccades (rapid eye movements), near-point convergence, balance vision reflex and visual motion sensitivity. For each domain, the sum of the symptoms is scored, with a total possible score of 0 (no change) to 200 points (significant changes in symptom severity).

Study contacts

Contact information is provided by the study sponsor or research team.

Horia-Daniel Iancu, PhD

CONTACT

[email protected]

506-858-4000 ext. 4999

Stephanie Ward Chiasson, PhD, RD

CONTACT

[email protected]

506-858-4000 ext. 4090

Sponsors and collaborators

Lead sponsor

Universite de Moncton

Other

Collaborators

  • New Brunswick Health Research Foundation

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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