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Ketogenic Diet for Spinal Cord Injury

N/A
Recruiting
Led By Ceren Yarar-Fisher, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically motor complete and incomplete spinal cord injury, age 19-60
ASIA A, B, C or D (ASIA: Neurological Impairment Scale)
Must not have
Patients with evidence of renal insufficiency and liver disease by history, physical examination, and laboratory tests
Neurological (other than SCI), vascular and/or cardiac problems that may limit function and interfere with testing procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (within 72 hours of injury), 3 and 5 weeks
Awards & highlights

Summary

This trial will test whether a high-fat diet can improve quality of life for people with spinal cord injuries.

Who is the study for?
This trial is for individuals aged 19-60 with spinal cord injuries, classified as ASIA A, B, C or D. It's not suitable for pregnant women, those with kidney or liver issues, lung diseases, or other neurological/cardiac/vascular conditions that could affect testing.
What is being tested?
The study compares the effects of a high-fat ketogenic diet versus a standard diet over five weeks on motor and sensory recovery in spinal cord injury patients. It also looks at changes in blood sugar control and independence.
What are the potential side effects?
Potential side effects from a ketogenic diet may include fatigue, headache, dizziness during initial adjustment (keto flu), digestive discomforts like constipation or diarrhea, and possible nutrient deficiencies if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury and am between 19 and 60 years old.
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My spinal cord injury is classified as ASIA A, B, C, or D.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have kidney and liver problems confirmed by tests.
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I do not have heart, blood vessel, or nerve problems that could affect my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (within 72 hours of injury), 3 and 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (within 72 hours of injury), 3 and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in sensory and motor function
Secondary study objectives
Change in functional Independence
Change in serum biomarkers for neurorecovery
Change in serum glucose concentration
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard Diet GroupExperimental Treatment1 Intervention
Patients will start to receive standard hospital diet within 72 hours of injury after completing their baseline measurements. Standard diet includes ≈35% total energy as fat, ≈27% as protein, and ≈44% as carbohydrate and fiber.
Group II: Ketogenic Diet GroupExperimental Treatment1 Intervention
Ketogenic diet is a high-fat, low-carbohydrate diet (lipid to carbohydrate + protein ratio of 3:1) that included ≈72% total energy as fat, ≈25% as protein, and ≈3% as carbohydrate during enteral feeding and ≈65% total energy as fat, ≈27% as protein, and ≈8% as carbohydrate and fiber during solid feeding. Patients will start receiving ketogenic diet within the 72 hours injury, after completing their baseline measurements.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,705 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,918 Total Patients Enrolled
Ceren Yarar-Fisher, PhDPrincipal Investigator - Ohio State University
University of Alabama at Birmingham
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03509571 — N/A
Spinal Cord Injury Research Study Groups: Standard Diet Group, Ketogenic Diet Group
Spinal Cord Injury Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT03509571 — N/A
Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509571 — N/A
~11 spots leftby Jan 2026
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