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

NCT05589064 | Recruiting

• 1 other identifier: 101616
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline and Endpoint (Week 8)

Secondary Outcomes (2)

• 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)

Study Arms (3)

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.

Behavioral: Experimental: Dietetic counseling; Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate; Behavioral: Other : Physiotherapy treatment

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.

Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate; Behavioral: Other : Physiotherapy treatment

Physiotherapy treatment (control group)

OTHER

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

Behavioral: Other : Physiotherapy treatment

Interventions

Experimental: Dietetic counseling BEHAVIORAL

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

Dietary intervention and nutritional supplements (group A)

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.

Dietary intervention and nutritional supplements (group A); Nutritional supplements (group B)

Other : Physiotherapy treatment BEHAVIORAL

Patients will receive weekly physiotherapy treatment.

Dietary intervention and nutritional supplements (group A); Nutritional supplements (group B); Physiotherapy treatment (control group)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Universite de Moncton: lead
• New Brunswick Health Research Foundation: collaborator

Study Sites (1)

Universite de Moncton

Moncton, New Brunswick, E1A 3E9, Canada

RECRUITING

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MeSH Terms

Conditions

Brain Concussion

Interventions

Cholecalciferol; Creatine

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Stephanie Ward Chiasson, PhD, RD

  Universite de Moncton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ward Chiasson, PhD, RD

CONTACT

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

Horia-Daniel Iancu, PhD

CONTACT

506-858-4000; horia-daniel.iancu@umoncton.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)