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

Lawson Health Research Institute

Status: Completed

Conditions: Inflammation; Spinal Cord Injury

Treatments: Other: Placebo Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04271904

AINP001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

16 participants in 2 patient groups

Placebo Diet

Sham Comparator group

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).

Treatment:

Other: Placebo Diet

Non-dieting Control

No Intervention group

Description:

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