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出境医 / 临床实验 / A Pilot Nutrition Program for Spinal Cord Injury and MS

A Pilot Nutrition Program for Spinal Cord Injury and MS

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Multiple Sclerosis Other: Diet group Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Diet group

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:

  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 previously studied in Allison and Ditor (2015).
  2. 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.
  4. Once per month, we will be offering a live cooking class.
Other: Diet group
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).

No Intervention: Control group
The control group will eat their usual diet for the 12-week period.
Outcome Measures
Primary Outcome Measures :
  1. Change from baseline body composition at 12 weeks [ 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.

  2. Change from baseline inflammation at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for various inflammatory mediators

  3. Change from baseline neuropathic pain at 12 weeks [ 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

  4. Change from baseline depression at 12 weeks [ 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.

  5. Change from baseline perceived quality of Life at 12 weeks [ 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

  6. Change from baseline blood lipids at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for blood lipids

  7. Change from baseline glucose tolerance at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for HbA1c


Secondary Outcome Measures :
  1. Dietary intake [ 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: David S Ditor, PhD 9056885550 ext 5338 dditor@brocku.ca

Locations
Layout table for location information
Canada, Ontario
Brock University
Saint Catharines, Ontario, Canada, L2S 3A1
Contact: David S Ditor, PhD    9056885550 ext 5338    dditor@brocku.ca   
Contact: Ally Fast, BSc    9056885550 ext 5585    afast@brocku.ca   
Sponsors and Collaborators
Brock University
Investigators
Layout table for investigator information
Principal Investigator: David S Ditor, PhD Brock University
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date January 14, 2020
Estimated Study Start Date  ICMJE February 15, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Change from baseline body composition at 12 weeks [ 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.
  • Change from baseline inflammation at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for various inflammatory mediators
  • Change from baseline neuropathic pain at 12 weeks [ 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
  • Change from baseline depression at 12 weeks [ 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.
  • Change from baseline perceived quality of Life at 12 weeks [ 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
  • Change from baseline blood lipids at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for blood lipids
  • Change from baseline glucose tolerance at 12 weeks [ Time Frame: Before and after the 12-week nutrition program (in both groups) ]
    Blood samples will be analyzed for HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Dietary intake [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Nutrition Program for Spinal Cord Injury and MS
Official Title  ICMJE A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Multiple Sclerosis
Intervention  ICMJE Other: Diet group
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).
Study Arms  ICMJE
  • Experimental: Diet group

    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:

    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 previously studied in Allison and Ditor (2015).
    2. 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.
    4. Once per month, we will be offering a live cooking class.
    Intervention: Other: Diet group
  • No Intervention: Control group
    The control group will eat their usual diet for the 12-week period.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David S Ditor, PhD 9056885550 ext 5338 dditor@brocku.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977922
Other Study ID Numbers  ICMJE 18-309 - Ditor
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Ditor, Brock University
Study Sponsor  ICMJE Brock University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S Ditor, PhD Brock University
PRS Account Brock University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP