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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589064 on ClinicalTrials.gov