Recruiting

Dietary Intervention

Sponsor:

Universite de Moncton

Code:

NCT05589064

Conditions

Brain Injury Traumatic Mild

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Experimental: Dietetic counseling

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

Other : Physiotherapy treatment

Study Details

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.

Conditions

Brain Injury Traumatic Mild

Study ID

NCT05589064

Start date

Oct 1, 2022

Status verified date

Dec, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dietary intervention and nutritional supplements (group A)

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.

active comparator: Nutritional supplements (group B)

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.

other: Physiotherapy treatment (control group)

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

Interventions

Experimental: Dietetic counseling

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

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

Other : Physiotherapy treatment

Patients will receive weekly physiotherapy treatment.

Primary outcome measure

  • Change from baseline in severity of post-concussive symptoms at the end of the intervention [ Time Frame: Baseline and Endpoint (Week 8) ]

Central Contacts and Locations

Central contacts

Stephanie Ward Chiasson, PhD, RD

506-858-4000stephanie.ward@umoncton.ca

Locations

Universite de Moncton

Recruiting

Moncton, New Brunswick, Canada, E1A 3E9

Contacts

Stephanie Ward Chiasson, PhD, RD

506-858-4000stephanie.ward@umoncton.ca

More Information

Sponsor

Universite de Moncton

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • Dietary intervention
  • Supplements
  • Omega-3
  • Vitamin D
  • Creatine monohydrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universite de Moncton on 2024-12-13.