Ketogenic diet to enhance recovery after spinal cord injury
Evaluation of a Ketogenic Diet for Improvement of Neurological Recovery in Individuals With Acute Spinal Cord Injury
NA · Ohio State University · NCT03509571
This study is testing if a ketogenic diet can help people with spinal cord injuries recover better than a standard diet over five weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03509571 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of a ketogenic diet compared to a standard diet on motor and sensory function, glycemic function, and functional independence in patients with spinal cord injuries. The study will involve a 5-week dietary intervention to assess improvements in neurorecovery, addressing the urgent need for innovative therapies in this area. Given the limitations of current pharmacological treatments, this research explores the potential of diet-based therapies to enhance recovery outcomes after spinal cord injury.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 19-60 with clinically motor complete and incomplete spinal cord injuries classified as ASIA A, B, C, or D.
Not a fit: Patients with other neurological, vascular, or cardiac issues, as well as those with renal insufficiency or liver disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in recovery and quality of life for patients with spinal cord injuries.
How similar studies have performed: While there is accumulating evidence supporting diet-based therapies for neuroprotection, this specific approach using a ketogenic diet in spinal cord injury is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically motor complete and incomplete spinal cord injury, age 19-60 * ASIA A, B, C or D (ASIA: Neurological Impairment Scale) Exclusion Criteria: * Pregnant women. * Neurological (other than SCI), vascular and/or cardiac problems that may limit function and interfere with testing procedures * Patients with evidence of renal insufficiency and liver disease by history, physical examination, and laboratory tests * Patients with underlying pulmonary diseases
Where this trial is running
Columbus, Ohio
- Ohio State University Hospital — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Ceren Yarar-Fisher, PhD — Ohio State University
- Study coordinator: Ceren Yarar-Fisher, PhD
- Email: yarar-fisher.1@osu.edu
- Phone: 205-977-0891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries