Ketogenic Diet to Improve Neuro-recovery

NCT03509571 | Recruiting

• 1 other identifier: 1R01NR016443-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change in sensory and motor function

  The ASIA Motor Index Score will be used for measuring motor function. This index uses standard manual muscle testing on a six grade scale. The total possible score from upper and lower extremity is 50. For the sensory examination, each dermatome will be tested for both sharp (pin-prick) and light-touch sensation and will be graded on a three point scale. Numerically, the sensory scores total 116 points. Measurement of motor and sensory function will take about an hour and will be performed 3 times during the course of the study.

  Baseline (within 72 hours of injury), 3 and 5 weeks

Secondary Outcomes (4)

• Change in serum glucose concentration

  Baseline (within 72 hours of injury), 3 and 5 weeks

• Change in functional Independence

  Baseline (within 72 hours of injury), 3 and 5 weeks

• Change in serum biomarkers for neurorecovery

  Baseline (within 72 hours of injury), 3 and 5 weeks

• Change in serum insulin concentration

  Baseline (within 72 hours of injury), 3 and 5 weeks

Study Arms (2)

Ketogenic Diet Group

EXPERIMENTAL

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.

Other: Ketogenic Diet

Standard Diet Group

OTHER

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.

Other: Standard Diet

Interventions

Ketogenic Diet OTHER

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.

Ketogenic Diet Group

Standard Diet OTHER

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.

Standard Diet Group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• Demirel A, Li J, Morrow C, Barnes S, Jansen J, Gower B, Kirksey K, Redden D, Yarar-Fisher C. 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. 2020 May 4;21(1):372. doi: 10.1186/s13063-020-04273-7.

  PMID: 32366293 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ceren Yarar-Fisher, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Raquel Minarsch, DPT

  Ohio State University

  STUDY DIRECTOR

Central Study Contacts

Ceren Yarar-Fisher, PhD

CONTACT

205-977-0891; yarar-fisher.1@osu.edu

Raquel Minarsch, DPT

CONTACT

330-881-1710; raquel.minarsch@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 26, 2018
• Study Start: May 9, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)