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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (within 72 hours of injury), 3 and 5 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met