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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how diet and nutrition can aid individuals with ongoing concussion symptoms. Researchers will divide participants into three groups: one receiving dietetic counseling (dietary advice and supplements), another receiving only supplements (Omega-3, vitamin D3, and creatine monohydrate), and a third undergoing only physiotherapy. The trial seeks participants in New Brunswick who have experienced concussion symptoms for at least two weeks but no more than six months. This study will help determine if dietary changes or supplements can ease recovery alongside standard care. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on concussion recovery through dietary changes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3, vitamin D, and creatine monohydrate supplements are generally safe for most people. Studies indicate that omega-3 fatty acids, such as DHA, can reduce inflammation and support brain health after a concussion, aiding in better recovery. Consuming up to 5 grams of omega-3 per day is considered safe for healthy individuals.

Vitamin D supports overall health and is well-tolerated by most people. Creatine monohydrate may reduce brain damage and maintain energy levels in the brain. These supplements are commonly used and do not typically cause major side effects in healthy adults.

Research also suggests that nutritional interventions can improve cognitive abilities and reduce anxiety and sleep problems. These findings indicate that the dietary and nutritional treatments in this study are expected to be safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for post-concussion syndrome because they combine dietary and nutritional interventions with physiotherapy, which is a fresh approach compared to typical treatments like rest and medication. The dietary intervention includes specific supplements like omega-3, vitamin D3, and creatine monohydrate, which are thought to support brain health and recovery in unique ways. This combination aims to not only address symptoms but also potentially speed up the recovery process by targeting inflammation and brain cell energy production. By integrating nutritional support with conventional therapy, these treatments offer a holistic angle that could enhance recovery outcomes for those with post-concussion syndrome.

What evidence suggests that this trial's treatments could be effective for post-concussion syndrome?

This trial will explore the effects of dietary and nutritional interventions for post-concussion syndrome. Research has suggested that certain nutrients might alleviate symptoms following a concussion. Participants in this trial may receive omega-3 fatty acids, vitamin D, and creatine, which could reduce swelling and protect the brain after an injury. Omega-3s, for instance, may decrease damage and support brain health, while creatine might enhance thinking skills and reduce long-term fatigue. Some studies also indicate that dietary changes can improve mood, memory, and sleep. Although these findings are promising, further research is needed to confirm the benefits for individuals with post-concussion syndrome. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephanie Ward Chiasson, PhD, RD

Principal Investigator

Universite de Moncton

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10490336/

A Potential Role Exists for Nutritional Interventions in the ... Outcomes: Improvement in neurocognitive outcomes, increased brain perfusion and self-reported increases in mood, memory, motivation, sleep and ...

2. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-9-2022-95aa3

Dietary and Nutritional Interventions for Post-Concussion ... 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- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12048115/

Dietary supplementation roles in concussion management In children with postconcussion syndrome, melatonin has been found to effectively increase sleep duration, reduce sleep-related issues, and ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.977728/full

Nutritional interventions to support acute mTBI recovery This review presents the potential for certain nutritional therapies to support the brain in recovery, specifically omega-3 fatty acids.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1089/neu.2022.0498

Nutritional Supplement and Dietary Interventions as a ... Eleven studies reported benefit of the intervention. Strongest evidence supports n-3FA utility for neurotrauma prevention in athletes exposed to SRHI. Both ...

6. trialx.com trialx.com/clinical-trials/listings/324976/evaluation-of-the-impact-of-a-dietary-and-nutritional-intervention-on-persistent-post-concussive-symptoms/

Evaluation of the Impact of a Dietary and Nutritional ... This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9614271/

Nutritional interventions to support acute mTBI recovery Our findings suggest that nutrition plays a positive role during acute mTBI recovery. Following mTBI, patient needs are unique, and this review ...

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2020.00160/full

The Ketogenic Diet in the Treatment of Post-concussion ... This pilot study assessed the feasibility and symptom-related effects of a ketogenic diet (KD) in patients with PCS symptoms.