Effect of Sham Anti-inflammatory Diet on Inflammation After Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT04271904
• Recruitment Status: Completed
• First Posted: February 17, 2020
• Last Update Posted: January 17, 2023
• Sponsor: Lawson Health Research Institute
• Collaborator: Ontario Neurotrauma Foundation
• Information provided by (Responsible Party): Lawson Health Research Institute

Study Description

Brief Summary:

This pilot study will evaluate the effects of a placebo anti-inflammatory diet in individuals with spinal cord injury. It is being performed to ensure that the placebo diet does not induce reductions in inflammation and also adequately conceals group allocation.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury; Inflammation	Other: Placebo Diet	Not Applicable

Detailed Description:

Anti-inflammatory diet is a novel treatment that may be beneficial for managing chronic inflammation and neuropathic pain (NP) after Spinal Cord Injury (SCI). NP is a common complication following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications.

As pain is a subjective outcome, awareness of group allocation could influence treatment expectations and participant rated scores of neuropathic pain. It is therefore important to ensure that an adequate placebo intervention is utilized. This pilot study will assess whether the placebo diet to be used in an upcoming RCT provides sufficient group allocation concealment (i.e. ensure participants are unaware of whether they are on the anti-inflammatory diet or placebo diet). This pilot study will also assess whether the placebo diet is in fact inflammation neutral (ie. induces no reductions in inflammation).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eligible participants who consent to study participation will be randomized to one of two groups: placebo diet, or non-dieting control. Those on the placebo diet will be given a meal plan and recipes while the non-dieting control group will be asked to continue eating as usual. The intervention will run for 4-week period.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: No other parties will be masked for the study.
• Primary Purpose: Treatment
• Official Title: Effect of a Sham Anti-inflammatory Diet on Inflammation and Participant Blinding in Spinal Cord Injury: A Pilot Study
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: June 3, 2022
• Actual Study Completion Date: June 3, 2022

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Placebo Diet; Participants on the placebo diet will be given a meal plan and recipes by the study dietitian. The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). There are many counter-intuitive restrictions in the anti-inflammatory diet that we will be using (banned foods include white beans, soy, eggplant, oats, raspberries, strawberries, prunes, walnuts, cashews, soy milk. Allowed foods include maple syrup, honey, lean beef, lamb, brown rice, feta cheese, butter). Therefore, even fairly astute and educated participants may have trouble discerning which diet they are consuming (anti-inflammatory or placebo).	Other: Placebo Diet; The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional "cheat" foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week).
No Intervention: Non-dieting Control; Those in the non-dieting control condition will not be asked to alter their diet in any way.

Outcome Measures

Primary Outcome Measures :

1. C-Reactive Protein [ Time Frame: Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention) ]
   Change in plasma C-reactive protein from baseline to post intervention.
2. Diet Compliance [ Time Frame: Week-5 (post measures collected following 1-week group allocation period and 4-week intervention) ]
   Diet compliance will be assessed following the intervention. Compliance to the specific diet will be assessed by a detailed analysis of all diet records. Each food item will be categorized as either a "food to consume," a "food to avoid," or a "neutral food" based on the parameter of the diet participants who were instructed to follow. Food will also be categorized into servings in accordance with Canada's Food Guide. Therefore, compliance score will be based on standard servings of foods subjects were instructed to eat vs. foods they were instructed to avoid. To account for differences in total energy intake, compliance scores will be expressed as a ratio of the servings of foods to consume over the total servings of food (avoid + consume) multiplied by 100. The percent compliance will then be generated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Signed informed consent obtained prior to any study-related activities
2. A spinal cord injury at least 6 months duration, nonprogressive for at least 6 months
3. Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.

Exclusion Criteria:

1. Current infection of any kind.
2. Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
3. Currently enrolled in another clinical trial
4. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
5. Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study

Contacts and Locations

Locations

Canada, Ontario

Parkwood Institute

London, Ontario, Canada, N6C 5J1

Sponsors and Collaborators

Lawson Health Research Institute

Ontario Neurotrauma Foundation

Investigators

• Principal Investigator: Eldon Loh, MD; Lawson Health Research Institute

More Information

Publications:

Loh E, Guy SD, Mehta S, Moulin DE, Bryce TN, Middleton JW, Siddall PJ, Hitzig SL, Widerstrom-Noga E, Finnerup NB, Kras-Dupuis A, Casalino A, Craven BC, Lau B, Cote I, Harvey D, O'Connell C, Orenczuk S, Parrent AG, Potter P, Short C, Teasell R, Townson A, Truchon C, Bradbury CL, Wolfe D. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: introduction, methodology and recommendation overview. Spinal Cord. 2016 Aug;54 Suppl 1:S1-6. doi: 10.1038/sc.2016.88.

Guy SD, Mehta S, Casalino A, Cote I, Kras-Dupuis A, Moulin DE, Parrent AG, Potter P, Short C, Teasell R, Bradbury CL, Bryce TN, Craven BC, Finnerup NB, Harvey D, Hitzig SL, Lau B, Middleton JW, O'Connell C, Orenczuk S, Siddall PJ, Townson A, Truchon C, Widerstrom-Noga E, Wolfe D, Loh E. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: Recommendations for treatment. Spinal Cord. 2016 Aug;54 Suppl 1:S14-23. doi: 10.1038/sc.2016.90.

Allison DJ, Thomas A, Beaudry K, Ditor DS. Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial. J Neuroinflammation. 2016 Jun 17;13(1):152. doi: 10.1186/s12974-016-0625-4.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04271904
• Other Study ID Numbers: AINP001
• First Posted: February 17, 2020
• Last Update Posted: January 17, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Inflammation; Wounds and Injuries; Pathologic Processes; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System