Clinical trial NCT03977922: A Pilot Nutrition Program for Spinal Cord Injury and MS
Official title: A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Lead sponsor: Brock University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. Once per week (Monday mornings), nutrition program members will come to Power Cord to pick up their box of ingredients for their meals that week (Monday to Friday). Recipe cards will accompany the ingredients, and enough food will be provided for 3 meals and 2 snacks per day. The meals will be based on the anti-inflammatory diet mentioned above. The nutrition program will not provide ingredients for Saturdays and Sundays, for three reasons. First, research has shown that occasional "cheat meals" help with long term compliance to the diet. Second, members should eventually become self-sufficient and even wean themselves off the nutrition program (or reduce their involvement). Third, this reduces the cost of the program and will help with long term sustainability.
2. To assist the members with meal preparation, there will also be 10-12 online videos that cover basic kitchen/cooking skills, how to prepare the meals in the program, how to shop for healthy foods at the grocery store, etc.
3. At the beginning of the program each member will be provided with a few pieces of accessible kitchen equipment that will made food preparation and cooking much easier. The equipment includes, a 1 Second Slicer (to be used in place of a knife), a padded lap tray (to be used as a cutting surface on the lap instead of a counter), a toaster oven, light weight pots and pans, a Nutri Bullet Blender.
4. Once per month, there will be a live cooking class.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals with spinal cord injury may be of any level of injury (paraplegia/tetraplegia) and severity of injury (complete/incomplete) and will be at least one year post-injury.
* Individuals with MS will have a diagnosis of relapsing remitting MS or secondary progressive MS, and will be at least one year post-diagnosis.

Exclusion Criteria:

* . Participants will be asymptomatic for pressure ulcers, urinary tract infections or respiratory infections at the time of recruitment, and they may be recreationally active but those participating in elite or high-level athletics/training will be excluded from the study.

Primary outcomes:
measure: Change from baseline body composition at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline inflammation at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline neuropathic pain at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline depression at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline perceived quality of Life at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline blood lipids at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
measure: Change from baseline glucose tolerance at 12 weeks
timeFrame: Before and after the 12-week nutrition program (in both groups)
Secondary outcomes:
measure: Dietary intake
timeFrame: At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)
Other outcomes:
Locations:
city: Saint Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: David S Ditor, PhD
role: PRINCIPAL_INVESTIGATOR
References: