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The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099890
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
David Ditor, Brock University

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 31, 2014
Last Update Posted Date July 30, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Change from baseline in nerve conduction velocity of somatic nerves at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
Assessment of motor and sensory nerve conduction velocity via electrically evoked potentials of the median nerve
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • Change in baseline in autonomic function scores on the Autonomic Standards Assessment Form at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    Questionnaire pertaining to urinary, bowel, and sexual function
  • Change in baseline pain scores on the Neuropathic Pain Questionnaire at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    Questionnaire pertaining to the type of pain felt (eg. burning, stabbing, throbbing), how the pain affects the participant (eg. ability to perform activities of daily living), and how various stimuli may increase pain (eg. increased pain due to heat).
  • Change in baseline concentrations of pro-inflammatory eicosanoids at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    The potent pro-inflammatory and pain inducing eicosanoids prostaglandin-2 (PGE2) and leukotriene-4 (LTB4) as well as the less potent eicosanoids prostaglandin-3 and leukotriene-5 (LTB5) will be assessed.
  • Change in baseline depression scores on the Centre for Epidemiological Studies Depression Scale at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    Questionnaire pertaining to how often participants felt a variety of depressive symptoms over the previous 7 days.
  • Change in baseline concentrations of peripheral tryptophan and other large neutral amino acids at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    The amino acid tryptophan (TRP) as well as other large neutral amino acids (LNAA) including leucine, isoleucine, valine, and tyrosine will be assessed to determine the TRP/LNAA ratio.
  • Change in baseline episodic learning and memory scores on the California Verbal Learning Test at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
    Verbal test of word recall.
  • Change in baseline concentrations of serum tryptophan and kynurenine levels at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury
Official Title  ICMJE Neural Consequences of Chronic Inflammation in Individuals With Spinal Cord Injury and the Influence of an Anti-inflammatory Diet
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Depression
  • Cognitive Impairment
  • Somatic Neuropathy
  • Autonomic Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Omega-3
    Other Name: Now Ultra Omega-3
  • Dietary Supplement: Vegetation Protein Powder
    Other Name: Progressive Veggessential Protein Powder
  • Dietary Supplement: InflanNox
    Other Names:
    • AOR InflanNox
    • Curcumin
  • Dietary Supplement: Anti-oxidant Network
    Other Name: CanPrev Anti-oxidant Network
  • Dietary Supplement: Chlorella
    Other Name: Now Chlorella
Study Arms  ICMJE Experimental: Anti-inflammatory Supplementation
Omega-3 pill (500 EPA / 250 DHA) taken orally 3 times daily, Vegetation Protein Powder (45g) taken orally once daily, InflanNox capsule (400mg curcumin) taken 3 times daily, Anti-oxidant Network capsule (615mg) taken twice daily, Chlorella tablet (1000mg) taken 6 times daily
Interventions:
  • Dietary Supplement: Omega-3
  • Dietary Supplement: Vegetation Protein Powder
  • Dietary Supplement: InflanNox
  • Dietary Supplement: Anti-oxidant Network
  • Dietary Supplement: Chlorella
Publications * Allison DJ, Ditor DS. Targeting inflammation to influence mood following spinal cord injury: a randomized clinical trial. J Neuroinflammation. 2015 Nov 6;12:204. doi: 10.1186/s12974-015-0425-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
15
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals with Spinal Cord Injury over the age of 18

Exclusion Criteria:

  • Any allergies / food intolerances to any supplements used in the study. Any participants who are pregnant, breast feeding, diabetic, or have kidney disease will also be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099890
Other Study ID Numbers  ICMJE 13-192 - DITOR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Ditor, Brock University
Study Sponsor  ICMJE Brock University
Collaborators  ICMJE Ontario Neurotrauma Foundation
Investigators  ICMJE
Principal Investigator: David S. Ditor, PhD. Brock University
Principal Investigator: David J. Allison, MSc. Brock University
PRS Account Brock University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP