Ketogenic Diet to Improve Neuro-recovery

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT03509571
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
19 Years - 60 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 9, 2019
Status verified
Jul 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Ketogenic Diet Group
    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: Standard Diet Group
    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.

Primary Outcome Measure

Change in sensory and motor function [ Time Frame: Baseline (within 72 hours of injury), 3 and 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University HospitalColumbusOhio43210
Ceren Yarar-Fisher, PhD

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By research site
Ohio State University Hospital· Columbus, OH

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