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NCT Number: NCT04271904

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkwood Institute

London, Ontario, N6C 5J1, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Ontario Neurotrauma Foundation

Registry information

Official study title

Effect of a Sham Anti-inflammatory Diet on Inflammation and Participant Blinding in Spinal Cord Injury: A Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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