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A Pilot Nutrition Program for Spinal Cord Injury and MS

Primary Purpose

Spinal Cord Injuries, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diet group
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet group

Control group

Arm Description

The diet group will be involved in a 12-week pilot nutrition program based on the anti-inflammatory diet studied by Allison and Ditor (2015). The nutrition program will entail: 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 previously studied in Allison and Ditor (2015). 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. 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. Once per month, we will be offering a live cooking class.

The control group will eat their usual diet for the 12-week period.

Outcomes

Primary Outcome Measures

Change from baseline body composition at 12 weeks
Dual-energy x-ray absorptiometry (DEXA) to measure the percentage of body fat.
Change from baseline inflammation at 12 weeks
Blood samples will be analyzed for various inflammatory mediators
Change from baseline neuropathic pain at 12 weeks
The Neuropathic pain questionnaire will be used to determine self-reported neuropathic pain
Change from baseline depression at 12 weeks
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.
Change from baseline perceived quality of Life at 12 weeks
The Perceived Quality of Life questionnaire (PQOL) will be used to determine self-reported quality of life
Change from baseline blood lipids at 12 weeks
Blood samples will be analyzed for blood lipids
Change from baseline glucose tolerance at 12 weeks
Blood samples will be analyzed for HbA1c

Secondary Outcome Measures

Dietary intake
Food logs will be collected to determine adherence to the dietary intake during the 12-week study for both groups.

Full Information

First Posted
June 5, 2019
Last Updated
February 6, 2023
Sponsor
Brock University
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1. Study Identification

Unique Protocol Identification Number
NCT03977922
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University

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
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: 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet group
Arm Type
Experimental
Arm Description
The diet group will be involved in a 12-week pilot nutrition program based on the anti-inflammatory diet studied by Allison and Ditor (2015). The nutrition program will entail: 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 previously studied in Allison and Ditor (2015). 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. 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. Once per month, we will be offering a live cooking class.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will eat their usual diet for the 12-week period.
Intervention Type
Other
Intervention Name(s)
Diet group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline body composition at 12 weeks
Description
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)
Title
Change from baseline inflammation at 12 weeks
Description
Blood samples will be analyzed for various inflammatory mediators
Time Frame
Before and after the 12-week nutrition program (in both groups)
Title
Change from baseline neuropathic pain at 12 weeks
Description
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)
Title
Change from baseline depression at 12 weeks
Description
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)
Title
Change from baseline perceived quality of Life at 12 weeks
Description
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)
Title
Change from baseline blood lipids at 12 weeks
Description
Blood samples will be analyzed for blood lipids
Time Frame
Before and after the 12-week nutrition program (in both groups)
Title
Change from baseline glucose tolerance at 12 weeks
Description
Blood samples will be analyzed for HbA1c
Time Frame
Before and after the 12-week nutrition program (in both groups)
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Food logs will be collected to determine adherence to the dietary intake during the 12-week study for both groups.
Time Frame
At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Ditor, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
Saint Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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A Pilot Nutrition Program for Spinal Cord Injury and MS

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