Depression Clinical Trial
Official title:
Neural Consequences of Chronic Inflammation in Individuals With Spinal Cord Injury and the Influence of an Anti-inflammatory Diet
Spinal cord Injury (SCI) is a condition commonly associated with a state of chronic low-grade inflammation due to a variety of factors such heightened risk for infection and development of metabolic disorders. Many disorders which have been demonstrated to have an inflammatory basis have also been found to be at much higher prevalence following SCI. Such conditions include, but are not limited to, depression, cognitive impairment, neuropathic pain, and somatic/autonomic nerve function. The fact that such disorders have an inflammatory basis provides a unique opportunity to treat them with intervention strategies which target the immune system. Natural anti-inflammatory interventions including a diet consisting of foods and supplements with anti-inflammatory properties may be an effective option for treating inflammation in this population. As this treatment strategy will target the inflammatory basis of many disorders it would be expected to lead to a reduction in pro-inflammatory mediators thereby leading to more sustainable long-term immune improvements regarding enzyme function and protein balances. Despite this, surprisingly little research has focused on the use of anti-inflammatory foods for the treatment of chronic inflammatory conditions, and effects specific to SCI have been almost completely neglected. As such, the current study will focus on the daily intake of natural supplements with anti-inflammatory properties over a 3 month intervention and the effects on inflammation and associated disorders will be assessed. It is hypothesized that the supplementation will result in positive alterations in enzyme regulation and protein balances resulting in improvements in each of the outcome measures of interest.
Spinal cord injury (SCI) is a condition commonly associated with a state of chronic
inflammation due to a number of factors. A loss of motor and sensory function typically
results in a greater susceptibility to the development of acute secondary health
complications such as urinary tract infections and pressure sores resulting in frequent
bouts of inflammation. The loss of mobility also places these individuals at an elevated
risk for the development of a variety of metabolic disorders such as obesity and type 2
diabetes; each of which are independently associated with chronic inflammation.
Additionally, elevated levels of circulating proinflammatory cytokines and autoantibodies
have been shown to be present in the serum of individuals with SCI even when asymptomatic
for other secondary health complications. As such, following SCI, individuals are commonly
in a state of perpetual low grade inflammation. It has yet to be established whether or not
such elevations in proinflammatory mediators are beneficial to patients or if they are in
fact surrogate markers of further neurological impairment. Such mediators play critical
roles tissue repair however, it is also well established that the immune system has the
ability to communicate with other systems of the body. As such, the immune system has the
ability to influence and be influenced by other systems suggesting that immune dysfunction
has the capability (and likelihood) of influencing the nervous system to some degree. A
variety of neurological and behavioural disorders including depression, cognitive
impairment, and neuropathic pain have each been linked to a state of chronic inflammation
and are each at a dramatically elevated prevalence following SCI.
Pro-inflammatory mediators have been suggested to influence the nervous system via both
direct and indirect mechanisms. There is evidence to suggest cytokines may directly
influence somatic nerves by altering ion channel kinetics through channelopathy.
Pro-inflammatory cytokines have also been shown to possess the ability to up-regulate key
enzymes resulting in protein imbalances and/or increased production of neuromodulatory
proteins, which may influence the severity of a variety of neural disorders.
Presently, the majority of treatment strategies for conditions such as major depression and
pain utilize drug treatments which target "downstream" enzymes and receptors. As such, these
treatments provide fairly rapid and affective relief from symptoms. However, as this
strategy does not target the inflammatory basis of such disorders it provides only a
temporary solution whereby symptoms are likely to return upon the cessation of the
treatment. In addition, long term use of certain drug treatments such as selective serotonin
re-uptake inhibitors (SSRI's) may only enhance biochemical vulnerability and exacerbate
symptoms long-term. An understanding of how the immune and nervous systems interact may
provide a unique opportunity to treat neural and behavioral disorders by targeting aspects
of the immune system via anti-inflammatory interventions.
Natural anti-inflammatory interventions including a diet consisting of foods and supplements
with anti-inflammatory properties may be an effective option for treating inflammation in
this population. As this treatment strategy will target the inflammatory basis of many
disorders it would be expected to lead to a reduction in pro-inflammatory mediators thereby
leading to more sustainable long-term immune improvements. Despite this, surprisingly little
research has focused on the use of anti-inflammatory foods for the treatment of chronic
inflammatory conditions, and effects specific to SCI have been almost completely neglected.
The research objective of the present study is to evaluate the effects of a reduced
inflammatory state by means of an anti-inflammatory diet on depression, cognitive
impairment, neuropathic pain, and somatic and autonomic nerve function. Participants will be
placed on a 3 month anti-inflammatory diet consisting of daily supplementation including
omega-3 polyunsaturated fatty acids, InflanNox (curcumin), anti-oxidants, chlorella, and a
vegetarian protein powder. A focus on foods and supplements with natural anti-inflammatory
properties is expected to lead to beneficial reductions in the incidence of infections as
well as positive metabolic adaptations. Together, this should help to reduce elevated levels
of proinflammatory mediators. It is hypothesized that a reduction in pro-inflammatory
mediators will result in positive alterations in enzyme regulation leading to beneficial
changes in protein balances and ultimately improvements in each of the measures of outcome.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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