Brock University
Saint Catharines, Ontario, L2S 3A1, Canada
NCT Number: NCT03977922
The purpose of this study is to determine the feasibility of a 12-week pilot community-based nutrition program for individuals with spinal cord injury and multiple sclerosis, and to determine the effects of the nutrition program on body composition, inflammation, neuropathic pain, depression and quality of life.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Saint Catharines, Ontario, L2S 3A1, Canada
Spinal cord injury (SCI) and multiple sclerosis (MS) are both conditions characterized by chronic inflammation as indicated by elevated levels of circulating pro-inflammatory cytokines. These cytokines can have a wide array of negative impacts in the body. For example, pro-inflammatory cytokines can impair serotonin production and usage in the brain and thus increase the risk of depression. Likewise, they can sensitize nociceptors and increase the intensity and frequency of neuropathic pain. Recent work has shown that a 3-month anti-inflammatory diet is not only effective in reducing pro-inflammatory cytokines, but also reduced self-reported depression and neuropathic pain, by approximately 55% and 40%, respectively (Allison and Ditor, 2015; Allison et al., 2016). These data are very promising since both depression and neuropathic pain are highly prevalent after SCI and MS, and current pharmacological treatments are only partially effective and associated with unwanted side-effects.
Despite the highly encouraging results mentioned above, one year following the conclusion of the study participants were no longer adhering to the anti-inflammatory diet. Specifically, during the actual study, adherence to the diet was, on average 89% (70-100%), while at one-year follow-up, adherence fell to, on average 43% (36-53%), which was virtually the same as baseline eating habits (Allison and Ditor, 2018). Likewise, measures of depression went back to baseline as well. These follow-up data prompted a subsequent qualitative study in which former participants were interviewed as a means to identify the facilitators and barriers that affect one's ability to adhere to the anti-inflammatory diet (Bailey et al., 2018). This qualitative study is now being used to inform a nutrition program that is in the early stages of development at a wheelchair accessible exercise facility; Power Cord.
The nutrition program will consist of 4 aspects:
Before this nutrition program can be long-term and sustainable, a 12-week pilot program will be completed to help determine the eventual membership pricing and feasibility. This pilot will also be used to determine the effects of the diet on body composition, inflammation, neuropathic pain, depression and quality of life. This pilot program will include 15 existing Power Cord members; 5 with SCI and 5 with MS who will be in the diet group, and 5 individuals with SCI and MS who will serve as controls. Participants in the pilot program will only pay $100/month for their involvement, and this will include their kitchen equipment, food for the 3-months, cooking classes and access to online content. The study and outcome measures described in this posting pertain to the 3-month pilot nutrition program.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The diet group will be involved in a 12-week pilot nutrition program that will be based on the anti-inflammatory diet previously studied by Allison and Ditor (2015).
Time frame: Before and after the 12-week nutrition program (in both groups)
Dual-energy x-ray absorptiometry (DEXA) to measure the percentage of body fat.
Time frame: Before and after the 12-week nutrition program (in both groups)
Blood samples will be analyzed for various inflammatory mediators
Time frame: Before and after the 12-week nutrition program (in both groups)
The Neuropathic pain questionnaire will be used to determine self-reported neuropathic pain
Time frame: Before and after the 12-week nutrition program (in both groups)
The Center for Epidemiological Studies Depression scale (CES-D) will be used to determine self-reported depression. This scale ranges from 0 to 60 with higher scored indicating more depression.
Time frame: Before and after the 12-week nutrition program (in both groups)
The Perceived Quality of Life questionnaire (PQOL) will be used to determine self-reported quality of life
Time frame: Before and after the 12-week nutrition program (in both groups)
Blood samples will be analyzed for blood lipids
Time frame: Before and after the 12-week nutrition program (in both groups)
Blood samples will be analyzed for HbA1c
Time frame: At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)
Food logs will be collected to determine adherence to the dietary intake during the 12-week study for both groups.
Brock University
Other
A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
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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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