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

NCT04271904 | Completed

• 1 other identifier: AINP001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Inflammation

Outcome Measures

Primary Outcomes (2)

• C-Reactive Protein

  Change in plasma C-reactive protein from baseline to post intervention.

  Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)

• Diet Compliance

  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.

  Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)

Study Arms (2)

Placebo Diet

SHAM COMPARATOR

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

Non-dieting Control

NO INTERVENTION

Those in the non-dieting control condition will not be asked to alter their diet in any way.

Interventions

Placebo Diet OTHER

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).

Placebo Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained prior to any study-related activities
• A spinal cord injury at least 6 months duration, nonprogressive for at least 6 months
• 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.

You may not qualify if:

• Current infection of any kind.
• Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
• Currently enrolled in another clinical trial
• 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
• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Parkwood Institute

London, Ontario, N6C 5J1, Canada

Location

Related Publications (3)

• 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.

  PMID: 27444714 BACKGROUND

• 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.

  PMID: 27444715 BACKGROUND

• 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.

  PMID: 27316678 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Inflammation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eldon Loh, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: No other parties will be masked for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: October 1, 2020
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)