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Dietary and Nutritional Interventions for Post-Concussion Syndrome
N/A
Recruiting
Led By Stephanie Ward Chiasson, PhD, RD
Research Sponsored by Universite de Moncton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and endpoint (week 8)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess the impact of dietary & nutritional interventions on post-concussion symptoms. Patients will be randomly assigned to receive different treatments. Symptoms will be monitored over 8 weeks.
Who is the study for?
This trial is for adults in New Brunswick, Canada, who have had post-concussive symptoms for 2 weeks to 6 months. Participants must understand English or French and be over the age of 16. It excludes those with other neurological disorders, moderate/severe brain injury history, active inflammatory bowel disease, conditions preventing physiotherapy, and pregnant or breastfeeding women.
What is being tested?
The study tests if dietetic counseling plus supplements (omega-3, vitamin D3 & creatine) can improve persistent concussion symptoms compared to just supplements or only physiotherapy. Patients are randomly assigned to one of these three groups and monitored through questionnaires over eight weeks.
What are the potential side effects?
Potential side effects may include digestive issues due to dietary changes or supplements and typical risks associated with physiotherapy such as muscle soreness or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and endpoint (week 8)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and endpoint (week 8)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Interventional procedure
Secondary study objectives
Interventional procedure
Change from baseline in vestibular ocular motor at the end of the intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Physiotherapy treatment (control group)Experimental Treatment1 Intervention
Patients in the control group will receive physiotherapy treatments over eight weeks.
Group II: Dietary intervention and nutritional supplements (group A)Experimental Treatment3 Interventions
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.
Group III: Nutritional supplements (group B)Active Control2 Interventions
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.
Find a Location
Who is running the clinical trial?
New Brunswick Health Research FoundationOTHER
10 Previous Clinical Trials
5,875 Total Patients Enrolled
Universite de MonctonLead Sponsor
10 Previous Clinical Trials
5,131 Total Patients Enrolled
Stephanie Ward Chiasson, PhD, RDPrincipal InvestigatorUniversite de Moncton