None listed
Conditions
Brief summary
Mild Traumatic Brain Injury (mTBI), also known as concussion, is a major public health problem for many countries. In New Zealand, over 90% of traumatic brain injuries are mild and occur most frequently as a result of falls, motor vehicle accidents, and assaults. The symptoms of mTBI can last anywhere from days to several months, or even years, after the initial incident. Symptoms may be physical (e.g. dizziness, headaches) emotional (e.g. anxiety, depression), and/or cognitive (e.g. difficulty with memory, attention, and processing speed). Naturally, many individuals struggle to perform the duties of their work and/or everyday life while suffering such symptoms, thus effective treatments are being sought. Fish oil is a commonly consumed over-the-counter nutritional supplement that may be effective for treating the symptoms of mTBI. Docosahexaenoic acid (DHA), a key component of fish oil, is the most abundant lipid in the human brain. It is important for brain development, both the structure and function of mature brain cells, and has shown efficacy at treating mTBI in rodents, as well as enhancing cognition in human adults. This supplement has not yet been the focus of a randomised control trial for treating mTBI in humans, which is necessary before it can be considered an effective treatment. For the present study, 96 mTBI sufferers will be assigned to either the treatment group consuming 4g fish oil (1990mg DHA) per day, or the control group consuming 4g sunflower oil per day, for six months. Participants will undergo cognitive testing and mood screening via telephone at baseline, three months, and six months before results are analysed for change over time and groups are compared. It is hypothesised that the fish oil group will display fewer mTBI symptoms than the placebo group at the three month and six month time points, thus exhibiting a quicker recovery.
Interventions
Participants in the treatment arm of the trial will swallow four 15mm long soft-gel capsules of fish oil every day for six months. This will equate to a daily dose of 1990mg docosahexaenoic acid (DHA) and 470mg eicosapentaenoic acid (EPA). Participants will be asked to take all four capsules in the morning with breakfast and a glass of water, however the timing may be altered for any participants who do not tolerate this, or do not consume breakfast; the daily dose will not be altered. The suppl
Participants in the treatment arm of the trial will swallow four 15mm long soft-gel capsules of fish oil every day for six months. This will equate to a daily dose of 1990mg docosahexaenoic acid (DHA) and 470mg eicosapentaenoic acid (EPA). Participants will be asked to take all four capsules in the morning with breakfast and a glass of water, however the timing may be altered for any participants who do not tolerate this, or do not consume breakfast; the daily dose will not be altered. The supplement will be issued by trained personnel from various Concussion Clinics, with information regarding dose and storage presented in both written and oral format. Participants will be provided with a diary to record when they have taken each dose, and note any potential side effects. They will be contacted via telephone by the lead researcher each month, to discuss tolerance and adherence to the treatment.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Individuals who have suffered a mTBI and are experiencing difficulty with one or more of the following cognitive domains will be eligible for inclusion: memory, attention, concentration, processing speed, and/or executive function. Participants must also be fluent in the English language, have access to a telephone and a distraction free environment for one hour every three months, and be able to hear clearly over the telephone.
Exclusion criteria
Individuals who are already taking fish oil, have taken fish oil in the last 6 months, or consume more than 3 servings of oily fish per week will be excluded. Anyone who has had recent surgery or is suffering from significant peripheral injury, is taking medication that affects cognitive function, or has any mental or neurological disorder that affects cognition will not be eligible to participate. Additionally, those with seafood allergy, aversion to fish/beef gelatin, difficulty swallowing capsules, or women who are pregnant or breastfeeding will be ineligible.
Outcome results
None listed