RecruitingNot ApplicableNCT03509571

Ketogenic Diet to Improve Neuro-recovery

Evaluation of a Ketogenic Diet for Improvement of Neurological Recovery in Individuals With Acute Spinal Cord Injury

Sponsor

Ohio State University

Enrollment

60 participants

Start Date

May 9, 2019

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries

Summary

The purpose of this project is to determine if 5 weeks of ketogenic (KD, high-fat) diet vs. standard diet (SD) significantly improves motor and sensory function, glycemic function, and functional independence in patients with spinal cord injury.

Eligibility

Min Age: 19 YearsMax Age: 60 Years

Inclusion Criteria2

Clinically motor complete and incomplete spinal cord injury, age 19-60
ASIA A, B, C or D (ASIA: Neurological Impairment Scale)

Exclusion Criteria4

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

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Interventions

OTHERKetogenic Diet

Enteral feeding via nasogastric (NG) or nasojejunal (NJ) tubes with ketogenic diet will start within 72 hours of injury and solid feeding will start as soon as the patient is able to swallow. This diet is a high-fat, low-carbohydrate diet (lipid to carbohydrate + protein ratio of 3:1) that will include ≈75% total energy as fat, ≈20% as protein, and ≈5% as carbohydrate and fiber.

OTHERStandard Diet

Enteral feeding via nasogastric (NG) or nasojejunal (NJ) tubes with SD diet will start within 72 hours of injury and solid feeding will start as soon as the patient is able to swallow. This diet includes ≈35% total energy as fat, ≈27% as protein, and ≈44% as carbohydrate and fiber.