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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Dietary Supplement: Anti-oxidant Network
Other Name: CanPrev Anti-oxidant Network
Dietary Supplement: Chlorella
Other Name: Now Chlorella
- 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
- 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 ]
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
|St Catharines, Ontario, Canada, L2S 3A1|
|Principal Investigator:||David S. Ditor, PhD.||Brock University|
|Principal Investigator:||David J. Allison, MSc.||Brock University|