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

Primary Purpose

Spinal Cord Injury, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Placebo Diet
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkwood Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

No Intervention

Arm Label

Placebo Diet

Non-dieting Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
January 13, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Neurotrauma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04271904
Brief Title
Effect of Sham Anti-inflammatory Diet on Inflammation After Spinal Cord Injury
Official Title
Effect of a Sham Anti-inflammatory Diet on Inflammation and Participant Blinding in Spinal Cord Injury: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Neurotrauma Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
No other parties will be masked for the study.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Diet
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
Non-dieting Control
Arm Type
No Intervention
Arm Description
Those in the non-dieting control condition will not be asked to alter their diet in any way.
Intervention Type
Other
Intervention Name(s)
Placebo Diet
Intervention Description
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 Outcome Measure Information:
Title
C-Reactive Protein
Description
Change in plasma C-reactive protein from baseline to post intervention.
Time Frame
Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)
Title
Diet Compliance
Description
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.
Time Frame
Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eldon Loh, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27444714
Citation
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.
Results Reference
background
PubMed Identifier
27444715
Citation
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.
Results Reference
background
PubMed Identifier
27316678
Citation
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.
Results Reference
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Effect of Sham Anti-inflammatory Diet on Inflammation After Spinal Cord Injury

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