Omega-3 Fatty Acids for Brain Injury
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Omega-3 supplements
Disqualifiers: Head injury, Cardiovascular diseases, Pregnancy, others
Trial Summary
What is the purpose of this trial?The purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] promote brain health against soccer heading. The study involves taking DHA+EPA or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are consuming omega-3 supplements or oily fish, you would need to stop before participating.
What data supports the effectiveness of the treatment Omega-3 Fatty Acids for brain injury?
Research in animals shows that omega-3 fatty acids, especially DHA, can reduce inflammation and improve recovery after brain injury. These studies suggest that omega-3s might help the brain heal better after injury by providing essential nutrients and reducing harmful inflammation.
12345Is omega-3 fatty acid supplementation safe for humans?
Omega-3 fatty acids, including DHA and EPA, are generally considered safe and well-tolerated in humans, with evidence suggesting they can be part of mainstream medicine due to their safety profile.
23567How does the treatment Omega-3 Fatty Acids differ from other treatments for brain injury?
Omega-3 Fatty Acids are unique because they are a dietary supplement that can help improve brain recovery after injury by reducing inflammation and protecting brain cells. Unlike other treatments, they work by maintaining the integrity of brain cell membranes and supporting nerve function, which can lead to better outcomes after a brain injury.
258910Eligibility Criteria
This trial is for individuals who regularly play soccer and are interested in the potential brain health benefits of Omega-3 fatty acids. Participants should be willing to undergo questionnaires, blood draws, brain imaging, heart function tests, and perform soccer headings.Inclusion Criteria
Current or former soccer player
I am between 18 and 30 years old.
Willing to commit to avoid any sport activity that purposefully uses one's head to maneuver during the study period (American football, ice-hockey, rugby, wrestling, and soccer heading)
+2 more
Exclusion Criteria
I have not had a head or neck injury in the last 6 months.
Implanted metal/magnetic devices (e.g., orthodontic braces)
I have been diagnosed with a heart or blood pressure condition.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive DHA+EPA or placebo supplementation and undergo soccer heading sessions
7 weeks
Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing whether taking supplements with Omega-3 fatty acids (DHA+EPA) can protect against brain impacts from heading a soccer ball. It's a double-blind study, meaning neither participants nor researchers know who gets the real supplement or placebo.
2Treatment groups
Active Control
Placebo Group
Group I: Omega-3 Fatty Acids (EPA plus DHA)Active Control2 Interventions
DHA+EPA capsules contain purified deep-sea fish oil, made from 100% wild-caught sardines and anchovies with a 3-year shelf life. The capsule shell is made from bovine limed bone with a size of 20 oblongs. Each soft gel capsule contains 480 mg of DHA, 205 mg of EPA, 145 mg of other omega-3 FA, and 10 mg of vitamin E. Participants in the DHA+EPA group will ingest 5 capsules daily \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].
Group II: Placebo: Organic soybean oil pillsPlacebo Group2 Interventions
We will use organic soybean oil pills ) as a placebo condition for the DHA+EPA group. One capsule contains 485 mg of organic soybean oil, including negligible amounts of DHA (1.1 mg), EPA (1.7 mg), and vitamin E (10 mg). Participants will ingest 5 capsules daily. Soybean oil is one of the most widely used vegetable oils in the world. Soybean oil contains polyunsaturated fats and 18-carbon omega-3 FA (total omega-3 FA of 73.9 mg per capsule), but very low levels of DHA and EPA, which makes it an excellent placebo counterpart when evaluating the effects of DHA/EPA. The placebo capsule's shelf life, composition, shape, size as the DHA+EPA active comparator.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University School of Public HealthBloomington, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Therapeutic use of omega-3 fatty acids in severe head trauma. [2021]Traumatic brain injury (TBI) has long been recognized as the leading cause of traumatic death and disability. Tremendous advances in surgical and intensive care unit management of the primary injury, including maintaining adequate oxygenation, controlling intracranial pressure, and ensuring proper cerebral perfusion pressure, have resulted in reduced mortality. However, the secondary injury phase of TBI is a prolonged pathogenic process characterized by neuroinflammation, excitatory amino acids, free radicals, and ion imbalance. There are no approved therapies to directly address these underlying processes. Here, we present a case that was intentionally treated with substantial amounts of omega-3 fatty acids (n-3FA) to provide the nutritional foundation for the brain to begin the healing process following severe TBI. Recent animal research supports the use of n-3FA, and clinical experience suggests that benefits may be possible from substantially and aggressively adding n-3FA to optimize the nutritional foundation of severe TBI patients and must be in place if the brain is to be given the opportunity to repair itself to the best possible extent. Administration early in the course of treatment, in the emergency department or sooner, has the potential to improve outcomes from this potentially devastating public health problem.
Effects of controlled cortical impact and docosahexaenoic acid on rat pup fatty acid profiles. [2023]Traumatic brain injury (TBI) is the leading cause of acquired neurologic disability in children, particularly in those under four years old. During this period, rapid brain growth demands higher Docosahexaenoic Acid (DHA) intake. DHA is an essential fatty acid and brain cell component derived almost entirely from the diet. DHA improved neurologic outcomes and decreased inflammation after controlled cortical impact (CCI) in 17-day old (P17) rats, our established model of pediatric TBI. In adult rodents, TBI decreases brain DHA. We hypothesized that CCI would decrease rat brain DHA at post injury day (PID) 60, blunted by 0.1% DHA diet. We quantitated fatty acids using Gas Chromatography-Mass Spectrometry. We provided 0.1% DHA before CCI to ensure high DHA in dam milk. We compared brain DHA in rats after 60 days of regular (REG) or DHA diet to SHAM pups on REG diet. Brain DHA decreased in REGCCI, not in DHACCI, relative to SHAMREG. In a subsequent experiment, we gave rat pups DHA or vehicle intraperitoneally after CCI followed by DHA or REG diet for 60 days. REG increased brain Docosapentaenoic Acid (n-6 DPA, a brain DHA deficiency marker) relative to SHAMDHA and DHACCI pups (p
Reduced acute neuroinflammation and improved functional recovery after traumatic brain injury by α-linolenic acid supplementation in mice. [2019]Adequate consumption of polyunsaturated fatty acids (PUFA) is vital for normal development and functioning of the central nervous system. The long-chain n-3 PUFAs docosahexaenoic acid (DHA) and eicosapentaenoic acid are anti-inflammatory and neuroprotective in the models of central nervous system injury including traumatic brain injury (TBI). In the present study, we tested whether a higher brain DHA status in a mouse model on an adequate dietary α-linolenic acid (ALA) leads to reduced neuroinflammation and improved spontaneous recovery after TBI in comparison to a moderately lowered brain DHA status that can occur in humans.
Docosahexaenoic acid decreased inflammatory gene expression, but not 18-kDa translocator protein binding, in rat pup brain after controlled cortical impact. [2023]Traumatic brain injury is the leading cause of acquired neurologic disability in children. In our model of pediatric traumatic brain injury, controlled cortical impact (CCI) in rat pups, docosahexaenoic acid (DHA) improved lesion volume and cognitive testing as late as postinjury day (PID) 50. Docosahexaenoic acid decreased proinflammatory messenger RNA (mRNA) in microglia and macrophages at PIDs 3 and 7, but not 30. We hypothesized that DHA affected inflammatory markers differentially relative to impact proximity, early and persistently after CCI.
Omega-3 fatty acid supplementation and reduction of traumatic axonal injury in a rodent head injury model. [2011]Traumatic brain injury remains the most common cause of death in persons under 45 years of age in the Western world. Recent evidence from animal studies suggests that supplementation with omega-3 fatty acid (O3FA) (particularly eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) improves functional outcomes following focal neural injury. The purpose of this study is to determine the benefits of O3FA supplementation following diffuse axonal injury in rats.
Omega-3 fatty acids and traumatic neurological injury: from neuroprotection to neuroplasticity? [2022]Omega-3 polyunsaturated fatty acids (PUFAs) are compounds that have a structural role in the nervous system and are essential for neurodevelopment. Results obtained with docosahexaenoic acid and eicosapentaenoic acid show therapeutic potential in neurotrauma. Traumatic brain injury (TBI) and spinal cord injury (SCI) can lead to major disability and have a significant socioeconomic cost. Thus, there is an unmet need for acute neuroprotection and for treatments that promote neuroregeneration. Acute administration of omega-3 PUFAs after injury and dietary exposure before or after injury improve neurological outcomes in experimental SCI and TBI. The mechanisms involved include decreased neuroinflammation and oxidative stress, neurotrophic support, and activation of cell survival pathways. This review raises questions that must be addressed before successful clinical translation.
Concussions, Traumatic Brain Injury, and the Innovative Use of Omega-3s. [2017]Traumatic brain injury (TBI), with its diverse heterogeneity and prolonged secondary pathogenesis, remains a clinical challenge. Clinical studies thus far have failed to identify an effective treatment strategy when a combination of targets controlling aspects of neuroprotection, neuroinflammation, and neuroregeneration is needed. Omega-3 fatty acids (n-3FA) offer the advantage of this approach. Although further clinical trial research is needed, there is a growing body of strong preclinical evidence and clinical experience that suggests that benefits may be possible from aggressively adding substantial amounts of n-3FA to optimize the nutritional foundation of TBI, concussion, and postconcussion syndrome patients. Early and optimal doses of n-3FA, even in a prophylactic setting, have the potential to improve outcomes from this potentially devastating problem. With evidence of unsurpassed safety and tolerability, n-3FA should be considered mainstream, conventional medicine, if conventional medicine can overcome its inherent bias against nutritional, nonpharmacologic therapies.
Omega-3 Fatty acids could alleviate the risks of traumatic brain injury - a mini review. [2021]Traumatic brain injury (TBI) is an acquired brain trauma that occurs when any sudden trauma/injury causes damage to the brain. TBI is characterized by tissue damage and imbalance in the cerebral blood flow and metabolism. It has been established through laboratory experiments that the dietary supplementation of omega-3 fatty acids (FAs) could reduce the oxidative stress developed in brain due to TBI. The inclusion of omega-3 FA in diet could normalize the levels of brain-derived neurotrophic factor (BDNF), and thus, it could restore the survival of neuronal cells. BDNF improves the synaptic transmission by regulating synapsin 1 and cyclic adenosine monophosphate (cAMP) response element binding protein. The brain tissue analysis of TBI models supplemented with omega-3 polyunsaturated fatty acids (PUFAs) showed significantly reduced lipid peroxidation, nucleic acid and protein oxidation, thereby promoting neuronal and glial cell survival. Thus, omega-3 FA intake could be considered as a therapeutic option to reduce the secondary neuronal damages initiated by TBI.
Depletion of brain docosahexaenoic acid impairs recovery from traumatic brain injury. [2021]Omega-3 fatty acids are crucial for proper development and function of the brain where docosahexaenoic acid (DHA), the primary omega-3 fatty acid in the brain, is retained avidly by the neuronal membranes. We investigated the effect of DHA depletion in the brain on the outcome of traumatic brain injury (TBI). Pregnant mice were put on an omega-3 fatty acid adequate or deficient diet from gestation day 14 and the pups were raised on the respective diets. Continuation of this dietary regime for three generations resulted in approximately 70% loss of DHA in the brain. Controlled cortical impact was delivered to both groups of mice to produce severe TBI and the functional recovery was compared. Compared to the omega-3 adequate mice, the DHA depleted mice exhibited significantly slower recovery from motor deficits evaluated by the rotarod and the beam walk tests. Furthermore, the DHA deficient mice showed greater anxiety-like behavior tested in the open field test as well as cognitive deficits evaluated by the novel object recognition test. The level of alpha spectrin II breakdown products, the markers of TBI, was significantly elevated in the deficient mouse cortices, indicating that the injury is greater in the deficient brains. This observation was further supported by the reduction of NeuN positive cells around the site of injury in the deficient mice, indicating exacerbated neuronal death after injury. These results suggest an important influence of the brain DHA status on TBI outcome.
Omega-3 polyunsaturated fatty acid supplementation improves neurologic recovery and attenuates white matter injury after experimental traumatic brain injury. [2021]Dietary supplementation with omega-3 (ω-3) fatty acids is a safe, economical mean of preventive medicine that has shown protection against several neurologic disorders. The present study tested the hypothesis that this method is protective against controlled cortical impact (CCI). Indeed, mice fed with ω-3 polyunsaturated fatty acid (PUFA)-enriched diet for 2 months exhibited attenuated short and long-term behavioral deficits due to CCI. Although ω-3 PUFAs did not decrease cortical lesion volume, these fatty acids did protect against hippocampal neuronal loss after CCI and reduced pro-inflammatory response. Interestingly, ω-3 PUFAs prevented the loss of myelin basic protein (MPB), preserved the integrity of the myelin sheath, and maintained the nerve fiber conductivity in the CCI model. ω-3 PUFAs also directly protected oligodendrocyte cultures from excitotoxicity and blunted the microglial activation-induced death of oligodendrocytes in microglia/oligodendrocyte cocultures. In sum, ω-3 PUFAs elicit multifaceted protection against behavioral dysfunction, hippocampal neuronal loss, inflammation, and loss of myelination and impulse conductivity. The present report is the first demonstration that ω-3 PUFAs protect against white matter injury in vivo and in vitro. The protective impact of ω-3 PUFAs supports the clinical use of this dietary supplement as a prophylaxis against traumatic brain injury and other nervous system disorders.