Potential for use of creatine supplementation following mild traumatic brain injury.
Philip John Ainsley Dean, Gozdem Arikan, Bertram Opitz...
https://pubmed.ncbi.nlm.nih.gov/30202575Actively Recruiting
Phase Not Applicable
Age: 16Years +
All Genders
ID05589064
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
Led by Universite de Moncton · Updated on 2024-12-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universite de Moncton
Lead Sponsor
N
New Brunswick Health Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Concussions affect many people, with 10-15% of adults experiencing symptoms that last weeks or months. Researchers are evaluating the effects of dietary and nutritional interventions on physical, cognitive, behavioral, and emotional symptoms in patients with persistent post-concussive symptoms. This randomized controlled trial compares three groups to understand the impact of diet and supplements alongside physiotherapy in New Brunswick, Canada. Participants are assigned to one of three groups: Group A receives dietary counseling with four dietitian consultations over eight weeks plus omega-3, vitamin D, and creatine supplements alongside physiotherapy. Group B takes the same supplements prescribed by their doctor and receives physiotherapy. The control group receives only physiotherapy treatments weekly for eight weeks. The study uses this design to determine the separate and combined effects of dietetic treatment and supplements. Participants complete a questionnaire assessing their symptoms at their first physiotherapy session and again at 2, 4, and 8 weeks after starting treatment. Researchers also monitor changes in post-concussive symptom severity, balance, and vestibular ocular motor function from baseline through week 8. This study helps measure whether dietary and nutritional interventions influence recovery alongside standard physiotherapy care.
CONDITIONS
Brief Title
Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
Who Can Participate
Age: 16Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 16 years or older
- Able to understand English or French
- Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months
You will not qualify if you...
- Younger than 16 years old
- Currently breastfeeding, pregnant, or planning pregnancy in the next 2 months
- Have neurological disorders other than concussion or a history of moderate or severe brain injury
- In an acute phase of inflammatory bowel disease
- Any physical condition preventing physiotherapy treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive dietary counseling, nutritional supplements, and physiotherapy treatments depending on their assigned group.
Four dietitian consultations and weekly physiotherapy visits over 8 weeks
Follow-up
Duration - 8 weeks
Participants complete questionnaires to assess changes in post-concussive symptoms at multiple time points after treatment starts.
Questionnaires completed at baseline, and at 2, 4, and 8 weeks
Trial Site Locations
Total: 1 location
1
Universite de Moncton
Moncton, New Brunswick, Canada, E1A 3E9
Actively Recruiting
Loading map...
Research Team
S
Stephanie Ward Chiasson, PhD, RD
H
Horia-Daniel Iancu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group.
Bahram Aminmansour, Hossein Nikbakht, Abbas Ghorbani...
https://pubmed.ncbi.nlm.nih.gov/23326789Vitamin D insufficiency and cognitive impairment in Asians: a multi-ethnic population-based study and meta-analysis.
C Annweiler, D Milea, H E Whitson...
https://pubmed.ncbi.nlm.nih.gov/27037788Malnutrition as measured by albumin and prealbumin on admission is associated with poor outcomes after severe traumatic brain injury.
Gerard A Baltazar, Amy J Pate, Benita Panigrahi...
https://pubmed.ncbi.nlm.nih.gov/25642858Characteristics and Incidence of Concussion Among a US Collegiate Undergraduate Population.
John Breck, Adam Bohr, Sourav Poddar...
https://pubmed.ncbi.nlm.nih.gov/31851345Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition.
Nancy Carney, Annette M Totten, Cindy O'Reilly...
https://pubmed.ncbi.nlm.nih.gov/27654000Vitamin D deficiency reduces the benefits of progesterone treatment after brain injury in aged rats.
Milos Cekic, Sarah M Cutler, Jacob W VanLandingham...
https://pubmed.ncbi.nlm.nih.gov/19482377Nutrition considerations in traumatic brain injury.
Aaron M Cook, Amy Peppard, Barbara Magnuson
https://pubmed.ncbi.nlm.nih.gov/19033220Nutritional treatment for acute and chronic traumatic brain injury patients.
L Curtis, P Epstein
https://pubmed.ncbi.nlm.nih.gov/24844176Beyond muscle: the effects of creatine supplementation on brain creatine, cognitive processing, and traumatic brain injury.
Eimear Dolan, Bruno Gualano, Eric S Rawson
https://pubmed.ncbi.nlm.nih.gov/30086660