Spinal Cord InjuriesNCT03977922
A Pilot Nutrition Program for Spinal Cord Injury and MS
A study testing Diet group in people with Spinal Cord Injuries and Multiple Sclerosis, run by Brock University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis
- What is being tested?
- Diet group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2022to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis
- Being tested
- Diet group
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet groupOther
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 group | Role | What they receive |
|---|---|---|
| Diet group | Experimental | 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. Receives: Other: Diet group |
| Control group | No intervention | The control group will eat their usual diet for the 12-week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body composition at 12 weeks
Dual-energy x-ray absorptiometry (DEXA) to measure the percentage of body fat.
Measured: Before and after the 12-week nutrition program (in both groups)
Change from baseline inflammation at 12 weeks
Blood samples will be analyzed for various inflammatory mediators
Measured: Before and after the 12-week nutrition program (in both groups)
Change from baseline neuropathic pain at 12 weeks
The Neuropathic pain questionnaire will be used to determine self-reported neuropathic pain
Measured: Before and after the 12-week nutrition program (in both groups)
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.
Measured: Before and after the 12-week nutrition program (in both groups)
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
Measured: Before and after the 12-week nutrition program (in both groups)
Change from baseline blood lipids at 12 weeks
Blood samples will be analyzed for blood lipids
Measured: Before and after the 12-week nutrition program (in both groups)
Change from baseline glucose tolerance at 12 weeks
Blood samples will be analyzed for HbA1c
Measured: Before and after the 12-week nutrition program (in both groups)
Secondary outcomes (1)
Dietary intake
Food logs will be collected to determine adherence to the dietary intake during the 12-week study for both groups.
Measured: At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start28 Feb 2022
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ditor, Brock University
- Investigators
- David S Ditor, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977922
- Sponsor's protocol ID
- 18-309 - Ditor
- Status last verified
- Feb 2023
- First submitted
- 5 Jun 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being
- ClinicalTrials.gov ID
- NCT03977922
- Acronym / sponsor ID
- 18-309 - Ditor
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet group | Experimental | Other: Diet groupThe 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. |
| Control group | No intervention | –The control group will eat their usual diet for the 12-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet groupThe 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). | Other | Diet group |
Primary outcome
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
1 secondary outcome
Dietary intake
Time frame: At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Ditor, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet group in people with Spinal Cord Injuries and Multiple Sclerosis, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body composition at 12 weeks (time frame: Before and after the 12-week nutrition program (in both groups)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.