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

NCT02099890 | Completed Phase 3

• 1 other identifier: 13-192 - DITOR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Depression; Cognitive Impairment; Somatic Neuropathy; Autonomic Dysfunction

Keywords

Chronic Inflammation; Spinal Cord Injury; Anti-inflammatory Diet; Neuropathic Pain; Depression; Cognitive Impairment; Somatic Nerve Function; Autonomic Nerve Function

Outcome Measures

Primary Outcomes (1)

• Change from baseline in nerve conduction velocity of somatic nerves at 3 and 6 months

  Assessment of motor and sensory nerve conduction velocity via electrically evoked potentials of the median nerve

  Baseline / 3 months / 6 months

Secondary Outcomes (7)

• Change in baseline in autonomic function scores on the Autonomic Standards Assessment Form at 3 and 6 months

  Baseline / 3 months / 6 months

• Change in baseline pain scores on the Neuropathic Pain Questionnaire at 3 and 6 months

  Baseline / 3 months / 6 months

• Change in baseline concentrations of pro-inflammatory eicosanoids at 3 and 6 months

  Baseline / 3 months / 6 months

• Change in baseline depression scores on the Centre for Epidemiological Studies Depression Scale at 3 and 6 months

  Baseline / 3 months / 6 months

• Change in baseline concentrations of peripheral tryptophan and other large neutral amino acids at 3 and 6 months

  Baseline / 3 months / 6 months

Study Arms (1)

Anti-inflammatory Supplementation

EXPERIMENTAL

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; Dietary Supplement: Vegetation Protein Powder; Dietary Supplement: InflanNox; Dietary Supplement: Anti-oxidant Network; Dietary Supplement: Chlorella

Interventions

Omega-3 DIETARY_SUPPLEMENT

Also known as: Now Ultra Omega-3

Anti-inflammatory Supplementation

Vegetation Protein Powder DIETARY_SUPPLEMENT

Also known as: Progressive Veggessential Protein Powder

Anti-inflammatory Supplementation

InflanNox DIETARY_SUPPLEMENT

Also known as: AOR InflanNox, Curcumin

Anti-inflammatory Supplementation

Anti-oxidant Network DIETARY_SUPPLEMENT

Also known as: CanPrev Anti-oxidant Network

Anti-inflammatory Supplementation

Chlorella DIETARY_SUPPLEMENT

Also known as: Now Chlorella

Anti-inflammatory Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with Spinal Cord Injury over the age of 18

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brock University: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 26545369 DERIVED

MeSH Terms

Conditions

Neuralgia; Depression; Cognitive Dysfunction; Primary Dysautonomias; Spinal Cord Injuries

Interventions

Docosahexaenoic Acids; Curcumin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Autonomic Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• David S. Ditor, PhD.

  Brock University

  PRINCIPAL INVESTIGATOR

• David J. Allison, MSc.

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

CA (1)