Study Summary
This trial will test whether a high-fat diet can improve quality of life for people with spinal cord injuries.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Weeks 1,2,3,4,5
Week 5
Change in functional Independence
Change in glucose tolerance
Change in sensory and motor function
Change in serum biomarkers for neurorecovery
Change in serum glucose concentration
Change in serum insulin concentration
Every week/once
Change in urine profile
Weeks 1,2,3,4,5
Change in microbiome composition
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Ketogenic Diet Group
1 of 1
Experimental Treatment
60 Total Participants · 1 Treatment Group
Primary Treatment: Ketogenic Diet · No Placebo Group · N/A
Ketogenic Diet Group
Other
Experimental Group · 1 Intervention: Ketogenic Diet · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1,2,3,4,5
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,432 Previous Clinical Trials
2,219,010 Total Patients Enrolled
Ceren Yarar-Fisher, PT, PhDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
Eligibility Criteria
Age 19 - 60 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a clinically complete or incomplete spinal cord injury, age 19-60.
You have a neurological impairment that causes you to have a limitation in your ability to perform the activity.
References
- Demirel, Aynur, Jia Li, Casey Morrow, Stephen Barnes, Jan Jansen, Barbara Gower, Keneshia Kirksey, David Redden, and Ceren Yarar-Fisher. 2020. “Evaluation of a Ketogenic Diet for Improvement of Neurological Recovery in Individuals with Acute Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04273-7.
- Ceren Yarar-Fisher 2019. "Ketogenic Diet to Improve Neuro-recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03509571.
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Conditions
Cancer Related
Treatments