Dietary and Nutritional Interventions for Post-Concussion Syndrome

Overseen By Horia-Daniel Iancu, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Universite de Moncton

Disqualifiers: Neurological disorders, Severe brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What data supports the idea that Dietary and Nutritional Interventions for Post-Concussion Syndrome is an effective treatment?

The available research shows that dietary and nutritional interventions, like omega-3 fatty acids and vitamin D, can be helpful for people with post-concussion syndrome. Omega-3 fatty acids, especially docosahexaenoic acid (DHA), have shown potential in managing concussions by protecting brain cells and reducing inflammation. Vitamin D has also demonstrated protective effects in brain injuries. A study on the ketogenic diet, which is high in fats and low in carbohydrates, showed improvements in memory and symptoms for some participants with post-concussion syndrome. These findings suggest that dietary changes can be a promising treatment option for managing symptoms after a concussion. ^{1 2 3 4 5}

What safety data exists for dietary and nutritional interventions in post-concussion syndrome?

The safety data for dietary and nutritional interventions in post-concussion syndrome includes studies on vitamin D, omega-3 fatty acids, and ketogenic diets. Vitamin D has shown neuroprotective properties in brain injury models. Omega-3 fatty acids, particularly docosahexaenoic acid, have been studied for their therapeutic potential in concussion management and are considered safe at doses up to 3,000 mg daily. A pilot study on the ketogenic diet reported some side effects like diarrhea and nausea, but it was generally feasible for participants. Overall, these interventions are considered safe, but further research is needed to confirm their efficacy and safety in larger populations. ^{1 2 3 4 5}

Is the treatment of dietetic counseling, Omega-3, vitamin D3, creatine monohydrate, and physiotherapy promising for post-concussion syndrome?

Yes, this treatment is promising. Omega-3 fatty acids and vitamin D have shown potential benefits for brain health and recovery after a concussion. Omega-3s may help reduce inflammation and support brain function, while vitamin D has protective effects on the brain. These nutritional interventions, combined with physiotherapy, could help improve symptoms and recovery in people with post-concussion syndrome. ^{1 2 3 6 7}

Research Team

Stephanie Ward Chiasson, PhD, RD

Principal Investigator

Universite de Moncton

Eligibility Criteria

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.

Inclusion Criteria

You have been experiencing concussion symptoms for more than two weeks but less than six months.

16 years or older

Must be able to understand English or French

Exclusion Criteria

You have a history of moderate to severe brain injury or a neurological disorder (excluding concussion).

You are currently experiencing a severe episode of inflammatory bowel disease.

You have a physical condition that prevents you from receiving physiotherapy treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary treatments, nutritional supplements, and/or physiotherapy treatments over eight weeks

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietetic counseling
• Omega-3, vitamin D3 and creatine monohydrate
• Physiotherapy treatment

Trial Overview 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.

Participant Groups

Group I: Physiotherapy treatment (control group) Experimental Treatment 1 Intervention

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

Group II: Dietary intervention and nutritional supplements (group A) Experimental Treatment 3 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 Control 2 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.

Who Is Running the Clinical Trial?

Universite de Moncton

Lead Sponsor

Trials

11

Recruited

5,300+

New Brunswick Health Research Foundation

Collaborator

Trials

11

Recruited

6,000+

Findings from Research

Vitamin D supplementation has shown neuroprotective effects in both animal models and a clinical study following traumatic brain injury (TBI), particularly when combined with progesterone, which enhances its benefits.

While vitamin D deficiency worsens inflammation after TBI, the current evidence does not support recommending vitamin D supplementation as a standard treatment to improve TBI outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the neuroprotective role of vitamin D in traumatic brain injury with implications for supplementation post-concussion. Lawrence, DW., Sharma, B.[2018]

A pilot study involving 14 participants with post-concussion syndrome (PCS) tested a ketogenic diet (KD) for 2 months, showing that 11 participants successfully achieved ketosis and reported improvements in visual memory and symptom scores.

The ketogenic diet was found to be a feasible treatment option for PCS, with some participants experiencing symptom relief, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet in the Treatment of Post-concussion Syndrome-A Feasibility Study. Rippee, MA., Chen, J., Taylor, MK.[2020]

A systematic review of 15 studies involving 1139 individuals with mild traumatic brain injury (mTBI) or sub-concussive repetitive head impacts (SRHIs) found that omega-3 fatty acids (n-3FA) showed strong evidence for preventing neurotrauma in athletes.

While melatonin and Pinus radiata may help with persistent post-concussion symptoms, more extensive multi-center studies are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Supplement and Dietary Interventions as a Prophylaxis or Treatment of Sub-Concussive Repetitive Head Impact and Mild Traumatic Brain Injury: A Systematic Review. Feinberg, C., Dickerson Mayes, K., Jarvis, RC., et al.[2023]

Omega-3 fatty acids, particularly docosahexaenoic acid, have shown potential therapeutic effects in various conditions, including concussion management, due to their mechanisms of action that may help address cellular and microstructural damage.

Recent research indicates that concussions can lead to metabolic and mitochondrial dysfunction in the brain, suggesting that omega-3 fatty acids could play a role in supporting recovery from such injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential for DHA to mitigate mild traumatic brain injury. Bailes, JE., Patel, V.[2017]

Omega-3 fatty acids (n-3 FAs), especially docosahexaenoic acid, have protective effects on the brain and can enhance recovery after traumatic brain injury, making them beneficial for athletes and soldiers.

Research suggests that administering n-3 FAs before an injury may also provide protective benefits, and their safety and affordability make them a viable option for those at risk of brain impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotection for the warrior: dietary supplementation with omega-3 fatty acids. Lewis, MD., Bailes, J.[2019]

In a study of 151 patients with severe traumatic brain injury (TBI), those receiving specialized enteral nutrition (EN) formulas with omega-3 polyunsaturated fatty acids (n-3 PUFAs) showed a reduced hospital length of stay compared to those on standard EN formulas.

Despite no significant differences in clinical markers of inflammation or infection rates, the findings suggest that immunonutrition may improve recovery times, particularly in patients with polytrauma, warranting further investigation into its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition with Omega-3 Fatty Acid Supplementation in Severe TBI: Retrospective Analysis of Patient Characteristics and Outcomes. Poblete, RA., Pena, JE., Kuo, G., et al.[2023]

Traumatic brain injury (TBI) affects 1.7 million people annually in the U.S., leading to significant disability, highlighting the urgent need for effective treatments.

This review identifies four promising nutritional interventions—omega-3, zinc, vitamin D, and glutamine—that may help mitigate the effects of TBI, suggesting that a multifaceted approach could be necessary for effective neurotherapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional treatment for traumatic brain injury. Scrimgeour, AG., Condlin, ML.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of the neuroprotective role of vitamin D in traumatic brain injury with implications for supplementation post-concussion. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet in the Treatment of Post-concussion Syndrome-A Feasibility Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Nutritional Supplement and Dietary Interventions as a Prophylaxis or Treatment of Sub-Concussive Repetitive Head Impact and Mild Traumatic Brain Injury: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The potential for DHA to mitigate mild traumatic brain injury. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Neuroprotection for the warrior: dietary supplementation with omega-3 fatty acids. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Immunonutrition with Omega-3 Fatty Acid Supplementation in Severe TBI: Retrospective Analysis of Patient Characteristics and Outcomes. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Nutritional treatment for traumatic brain injury. [2014]