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.
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.
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.
- Conditions
- Neuropathic Pain, Depression, Cognitive Impairment, Somatic Neuropathy, Autonomic Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
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)
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
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
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
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
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
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
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.
- First posted31 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, David Ditor, Brock University
- Investigators
- David S. Ditor, PhD., Principal investigator, Brock UniversityDavid J. Allison, MSc., Principal investigator, Brock University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Consequences of Chronic Inflammation in Individuals With Spinal Cord Injury and the Influence of an Anti-inflammatory Diet
- ClinicalTrials.gov ID
- NCT02099890
- Acronym / sponsor ID
- 13-192 - DITOR
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory Supplementation | Experimental | Dietary Supplement: Omega-3, Dietary Supplement: Vegetation Protein Powder, Dietary Supplement: InflanNox, Dietary Supplement: Anti-oxidant Network, Dietary Supplement: ChlorellaOmega-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with Spinal Cord Injury over the age of 18
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: Now Ultra Omega-3 | Dietary supplement | Anti-inflammatory Supplementation |
| Vegetation Protein PowderAlso: Progressive Veggessential Protein Powder | Dietary supplement | Anti-inflammatory Supplementation |
| InflanNoxAlso: AOR InflanNox, Curcumin | Dietary supplement | Anti-inflammatory Supplementation |
| Anti-oxidant NetworkAlso: CanPrev Anti-oxidant Network | Dietary supplement | Anti-inflammatory Supplementation |
| ChlorellaAlso: Now Chlorella | Dietary supplement | Anti-inflammatory Supplementation |
Primary outcome
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
7 secondary outcomes
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
Change in baseline pain scores on the Neuropathic Pain Questionnaire at 3 and 6 months
Time frame: Baseline / 3 months / 6 months
Change in baseline concentrations of pro-inflammatory eicosanoids at 3 and 6 months
Time frame: Baseline / 3 months / 6 months
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
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
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
Change in baseline concentrations of serum tryptophan and kynurenine levels at 3 and 6 months
Time frame: Baseline / 3 months / 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 26545369Allison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S. Ditor, PhD. principal investigator
Brock University
David J. Allison, MSc. principal investigator
Brock University
1 site in 1 country: see every site and its status.
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.