Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial.
Study Goal
The researchers aimed to assess the safety and feasibility of a ketogenic diet (KD) during acute care for spinal cord injury (SCI) and determine its effects on motor/sensory function, functional independence, and glycemic control.
Results Summary
The study found that 5 weeks of KD improved upper extremity motor function and reduced serum levels of a neuroinflammatory blood protein compared to a standard hospital diet in SCI patients. The study also aims to quantify serum biomarkers linked to neurological recovery.
Population
Acutely traumatic spinal cord injured participants (cervical 5 to thoracic 12), aged 18-60, with AIS grades A-C.
Effective Dosage
Not specified
Duration
5 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
ketogenic diet (KD) | increase | forelimb motor function | SCI rat model | - | has been shown to improve | #1 |
ketogenic diet (KD) | decrease | inflammation and cell death in the spinal cord | SCI rat model | - | likely by reducing | #2 |
5 weeks of KD | increase | upper extremity motor function | patients with SCI | - | improved | #3 |
5 weeks of KD | decrease | serum levels of a neuroinflammatory blood protein | patients with SCI | - | reduced | #4 |
5 weeks of a KD | increase | motor and sensory functions, functional independence and glycemic control | acutely traumatic spinal cord injured participants | - | significantly improves | #5 |
BACKGROUND: Therapies that significantly improve the neurological and functional recovery of individuals with spinal cord injury (SCI) are still urgently needed. The ketogenic diet (KD) has been shown to improve forelimb motor function in an SCI rat model, likely by reducing inflammation and cell death in the spinal cord. Furthermore, our recent pilot study in patients with SCI showed that, compared with a standard hospital diet (SD), 5 weeks of KD started during acute care improved upper extremity motor function and reduced serum levels of a neuroinflammatory blood protein. The primary goals of the current study are to: 1) show the safety and feasibility of administering a KD during acute care for SCI; 2) determine if consuming 5 weeks of a KD significantly improves motor and sensory functions, functional independence and glycemic control; and 3) quantify serum biomarkers that are linked to improvements in neurological recovery and functional independence via targeted proteomics. METHODS/DESIGN: In a single-masked, longitudinal, randomized, parallel-controlled study, a total of 60 eligible, acutely traumatic spinal cord injured (cervical 5 to thoracic 12) participants ranging in age from 18 to 60 years with American Spinal Injury Association impairment scale (AIS) grades A-C (AIS-A, sensorimotor complete; AIS-B, sensory incomplete/motor complete; and AIS-C, nonfunctional motor incomplete) are being enrolled. Neurological and functional examinations, resting energy expenditure, blood, urine, and stool collections, and protein analyses related to neurological recovery will be performed within 72 h of injury (baseline measure) and repeated after 5 weeks of KD or SD (discharge measure). We anticipate a completion rate of 80% with a total of 48 participants. DISCUSSION: Intervention with a more neuroprotective diet during acute care of SCI can be implemented anywhere in the world at low cost and without major regulatory hurdles. Better functional recovery will lead to a better quality of life and long-term health outcomes in individuals with SCI. While this study targets SCI, if successful it has the potential to improve neurological outcomes for individuals with various traumatic injuries. TRIAL REGISTRATION: NCT03509571 Registered on April 28, 2018.