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

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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

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Depression Cognitive Impairment Somatic Neuropathy Autonomic Dysfunction Dietary Supplement: Omega-3 Dietary Supplement: Vegetation Protein Powder Dietary Supplement: InflanNox Dietary Supplement: Anti-oxidant Network Dietary Supplement: Chlorella Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Consequences of Chronic Inflammation in Individuals With Spinal Cord Injury and the Influence of an Anti-inflammatory Diet
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change in baseline concentrations of serum tryptophan and kynurenine levels at 3 and 6 months [ Time Frame: Baseline / 3 months / 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099890


Locations
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Canada, Ontario
Brock University
St Catharines, Ontario, Canada, L2S 3A1
Sponsors and Collaborators
Brock University
Ontario Neurotrauma Foundation
Investigators
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Principal Investigator: David S. Ditor, PhD. Brock University
Principal Investigator: David J. Allison, MSc. Brock University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Ditor, Professor, Brock University
ClinicalTrials.gov Identifier: NCT02099890    
Other Study ID Numbers: 13-192 - DITOR
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by David Ditor, Brock University:
Chronic Inflammation
Spinal Cord Injury
Anti-inflammatory Diet
Neuropathic Pain
Depression
Cognitive Impairment
Somatic Nerve Function
Autonomic Nerve Function
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Autonomic Nervous System Diseases
Primary Dysautonomias
Inflammation
Depression
Cognitive Dysfunction
Behavioral Symptoms
Mental Disorders
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Curcumin
Antioxidants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents