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

Primary Purpose

Brain Injury Traumatic Mild

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Experimental: Dietetic counseling
Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
Other : Physiotherapy treatment
Sponsored by
Universite de Moncton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury Traumatic Mild focused on measuring Dietary intervention, Supplements, Omega-3, Vitamin D, Creatine monohydrate

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universite de Moncton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Dietary intervention and nutritional supplements (group A)

Nutritional supplements (group B)

Physiotherapy treatment (control group)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2022
Last Updated
October 17, 2022
Sponsor
Universite de Moncton
Collaborators
New Brunswick Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05589064
Brief Title
Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universite de Moncton
Collaborators
New Brunswick Health Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury Traumatic Mild
Keywords
Dietary intervention, Supplements, Omega-3, Vitamin D, Creatine monohydrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention and nutritional supplements (group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutritional supplements (group B)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physiotherapy treatment (control group)
Arm Type
Other
Arm Description
Patients in the control group will receive physiotherapy treatments over eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Dietetic counseling
Intervention Description
Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.
Intervention Type
Dietary Supplement
Intervention Name(s)
Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
Intervention Description
Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.
Intervention Type
Behavioral
Intervention Name(s)
Other : Physiotherapy treatment
Intervention Description
Patients will receive weekly physiotherapy treatment.
Primary Outcome Measure Information:
Title
Change from baseline in severity of post-concussive symptoms at the end of the intervention
Description
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).
Time Frame
Baseline and Endpoint (Week 8)
Secondary Outcome Measure Information:
Title
Change from baseline in balance at the end of the intervention
Description
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.
Time Frame
Baseline and Endpoint (Week 8)
Title
Change from baseline in vestibular ocular motor at the end of the intervention
Description
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).
Time Frame
Baseline and Endpoint (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Ward Chiasson, PhD, RD
Phone
506-858-4000
Ext
4090
Email
stephanie.ward@umoncton.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Horia-Daniel Iancu, PhD
Phone
506-858-4000
Ext
4999
Email
horia-daniel.iancu@umoncton.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Ward Chiasson, PhD, RD
Organizational Affiliation
Universite de Moncton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite de Moncton
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1A 3E9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Ward Chiasson, PhD, RD
Phone
506-858-4000
Ext
4090
Email
stephanie.ward@umoncton.ca
First Name & Middle Initial & Last Name & Degree
Horia-Daniel Iancu, PhD
Phone
506-858-4000
Ext
4999
Email
horia-daniel.iancu@umoncton.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be made available to researchers upon reasonable request made to the principal investigator.
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Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

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