A Pilot Nutrition Program for Spinal Cord Injury and MS: Effects on Inflammation, Cardiometabolic Health and Psychosocial Well-being

CompletedNot a drug-phase studyRelapsing and progressiveNCT03977922

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Diet group

What it measured

Main measures

  • Change from baseline body composition at 12 weeks

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

    Physical function
  • Change from baseline inflammation at 12 weeks

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

  • Change from baseline neuropathic pain at 12 weeks

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

    Pain
  • Change from baseline depression at 12 weeks

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

    Mood and sleep
  • Change from baseline perceived quality of Life at 12 weeks

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

    Quality of life (reported by participants)
  • Change from baseline blood lipids at 12 weeks

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

  • Change from baseline glucose tolerance at 12 weeks

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

Other measures (1)

  • Dietary intake

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

    Quality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 65

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Feb 2022

    2. Main results due

      Feb 2022

    3. Finished

      Feb 2022

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