Ketogenic Diet to Improve Neuro-recovery



Status:Active, not recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:19 - 60
Updated:4/28/2018
Start Date:April 14, 2017
End Date:March 2021

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Utilizing Ketogenic Diet to Improve Neuro- Recovery Following Spinal Cord Injury

The purpose of this project is to determine if 8 weeks of ketogenic (KD, high-fat) diet vs.
standard diet (SD) significantly improves motor and sensory function, gut function, and
functional independence in patients with complete SCI.

There is a growing need for innovative therapies for improving neuro-recovery following
spinal cord injury (SCI). Despite extensive research, clinical advancements, and improved
rehabilitation strategies, SCI continues to be a significant cause of disability and
mortality. Recent evidence shows that the diet-based therapies, such as ketogenic diet (KD)
offer effective neuro-protection against secondary injury cascades in a rat model of SCI. The
KD is a high-fat, low carbohydrate diet designed to mimic the metabolic and biochemical
changes seen during calorie restriction, specifically, ketosis.In this study our goal is to
determine if 8 weeks of KD vs. SD significantly improves motor and sensory function,
functional independence and gut microbiome composition in patients with complete SCI. 56
individuals with SCI (C5-T12/ American Spinal Injury Impairment Scale (AIS)21, 22 who are
starting enteral feeding will be randomly assigned to 8 weeks of KD or SD. Individuals'
caloric targets will be set by measuring resting energy expenditure via indirect calorimetry
prior to interventions. Patients will start solid KD or SD when they are able to swallow.
Blood ketones, motor and sensory recovery (via American Spinal Injury Association Impairment
Scale [REF]), and functional independence (via Spinal Cord Independence Measure) scores will
be measured before, after 4 and 8 weeks of KD vs. SD.

Inclusion Criteria:

- Clinically motor complete and incomplete spinal cord injury, age 18-60

- ASIA A and B (ASIA: Neurological Impairment Scale)

Exclusion Criteria:

- 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
We found this trial at
1
site
Birmingham, Alabama 35249
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Birmingham, AL
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