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

NCT04271904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-01-17

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Ontario Neurotrauma Foundation

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Eldon Loh, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-03
Completion
2022-06-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271904 on ClinicalTrials.gov