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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (within 72 hours of injury), 3 and 5 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a spinal cord injury and am between 19 and 60 years old.
Select...
My spinal cord injury is classified as ASIA A, B, C, or D.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sensory and motor function
Secondary outcome measures
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
821 Previous Clinical Trials
501,035 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,298 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for those over the age of 79 to partake in this research endeavor?

"This research accepts participants aged 19 to 60."

Answered by AI

Is this research still in need of participants?

"Affirmative. Data posted on clinicaltrials.gov confirms that this medical test, which was initially published in May of 2019, is actively searching for participants to take part. The trial necessitates 60 individuals from one facility."

Answered by AI

What is the current capacity for participants in this clinical trial?

"Indeed, the information hosted on clinicaltrials.gov demonstrates that this trial is in search of participants. It was initially posted on May 9th 2019 and updated most recently on October 5th 2022 with a goal to recruit 60 individuals at one medical centre."

Answered by AI

May I be considered as a participant in this medical experiment?

"This study is seeking 60 volunteers with spinal cord injuries, aged 19 to 60. Admittance criteria also necessitates that the participant must be clinically motor complete or incomplete and have an ASIA Impairment Scale of A, B, C or D."

Answered by AI
~10 spots leftby Mar 2025