Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
NCT ID: NCT05589064
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-10-01
2025-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Physiotherapy treatment (control group)
Patients in the control group will receive physiotherapy treatments over eight weeks.
Other : Physiotherapy treatment
Patients will receive weekly physiotherapy treatment.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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New Brunswick Health Research Foundation
OTHER
Universite de Moncton
OTHER
Responsible Party
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Principal Investigators
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Stephanie Ward Chiasson, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Universite de Moncton
Locations
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Universite de Moncton
Moncton, New Brunswick, Canada
Countries
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Central Contacts
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Facility Contacts
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Stephanie Ward Chiasson, PhD, RD
Role: primary
Horia-Daniel Iancu, PhD
Role: backup
References
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Other Identifiers
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101616
Identifier Type: -
Identifier Source: org_study_id