A Pilot Nutrition Program for Spinal Cord Injury and MS

NCT03977922 | Completed

• 1 other identifier: 18-309 - Ditor
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Multiple Sclerosis

Outcome Measures

Primary Outcomes (7)

• Change from baseline body composition at 12 weeks

  Dual-energy x-ray absorptiometry (DEXA) to measure the percentage of body fat.

  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

  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

  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.

  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

  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

  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

  Before and after the 12-week nutrition program (in both groups)

Secondary Outcomes (1)

• Dietary intake

  At baseline, and after 4 weeks, 8 weeks and 12 weeks (in both groups)

Study Arms (2)

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.

Other: Diet group

Control group

NO INTERVENTION

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

Interventions

Diet group OTHER

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).

Diet group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brock University: lead

Study Sites (1)

Brock University

Saint Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David S Ditor, PhD

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: February 28, 2022
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)