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Neuropathic PainPhase 3NCT02099890

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

A Phase 3 study testing Omega-3, Vegetation Protein Powder and InflanNox in people with Neuropathic Pain and Depression, run by Brock University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neuropathic Pain, Depression, Cognitive Impairment
What is being tested?
Omega-3, Vegetation Protein Powder and InflanNox
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Sep 2014to Feb 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals with Spinal Cord Injury over the age of 18

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Brock University

    St. Catharines, Ontario, L2S 3A1

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Omega-3, Vegetation Protein Powder, InflanNox, Anti-oxidant Network, Chlorella
Keywords
Chronic Inflammation, Spinal Cord Injury, Anti-inflammatory Diet, Neuropathic Pain, Depression, Cognitive Impairment, Somatic Nerve Function, Autonomic Nerve Function
Medical subject headings
Neuralgia, Depression, Cognitive Dysfunction, Primary Dysautonomias, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3Dietary supplement

    Also called Now Ultra Omega-3

  • Vegetation Protein PowderDietary supplement

    Also called Progressive Veggessential Protein Powder

  • InflanNoxDietary supplement

    Also called AOR InflanNox, Curcumin

  • Anti-oxidant NetworkDietary supplement

    Also called CanPrev Anti-oxidant Network

  • ChlorellaDietary supplement

    Also called Now Chlorella

Study groups in NCT02099890
Study groupRoleWhat they receive
Anti-inflammatory SupplementationExperimentalOmega-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
Receives: Dietary Supplement: Omega-3; Dietary Supplement: Vegetation Protein Powder; Dietary Supplement: InflanNox; Dietary Supplement: Anti-oxidant Network; Dietary Supplement: Chlorella

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline / 3 months / 6 months

Secondary outcomes (7)
  1. Change in baseline in autonomic function scores on the Autonomic Standards Assessment Form at 3 and 6 months

    Questionnaire pertaining to urinary, bowel, and sexual function

    Measured: Baseline / 3 months / 6 months

  2. Change in baseline pain scores on the Neuropathic Pain Questionnaire at 3 and 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).

    Measured: Baseline / 3 months / 6 months

  3. Change in baseline concentrations of pro-inflammatory eicosanoids at 3 and 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.

    Measured: Baseline / 3 months / 6 months

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

    Questionnaire pertaining to how often participants felt a variety of depressive symptoms over the previous 7 days.

    Measured: Baseline / 3 months / 6 months

  5. Change in baseline concentrations of peripheral tryptophan and other large neutral amino acids at 3 and 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.

    Measured: Baseline / 3 months / 6 months

  6. Change in baseline episodic learning and memory scores on the California Verbal Learning Test at 3 and 6 months

    Verbal test of word recall.

    Measured: Baseline / 3 months / 6 months

  7. Change in baseline concentrations of serum tryptophan and kynurenine levels at 3 and 6 months

    Measured: Baseline / 3 months / 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02099890
Sponsor's protocol ID
13-192 - DITOR
Status last verified
Jul 2015
First submitted
24 Mar 2014
Last updated
30 Jul 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 26545369

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3, Vegetation Protein Powder and InflanNox in people with Neuropathic Pain and Depression, run by Brock University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in nerve conduction velocity of somatic nerves at 3 and 6 months (time frame: Baseline / 3 months / 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02099890, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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