Objective: To conduct a clinical trial of ketogenic diet (KD) in patients with acute spinal cord injury (SCI) and evaluate its safety and feasibility by measuring blood ketone bodies and blood glucose levels.
Method: Ten patients with acute SCI were recruited in the trial during the period from May, 2012 to October, 2013. The patients received a standard KD after fasting for 48 h. The levels of blood ketone, blood glucose and uric ketone were tested daily, and routine blood examination, electrolytes, liver and kidney function, body mass index (BMI), sensory and motor function, and adverse reactions were monitored weekly to assess the safety and feasibility of KD.
Results: KD treatment lasted for a mean of 12.9 days (4 to 29 days) in these patients. In all the patients, blood ketone level increased during the fasting and maintained a level above 2.0 mmol/L after taking KD, while the uric ketone level ranged from +++ to ++++. The blood glucose level was in the normal range during KD. Except for blood chloride level and BMI, routine blood test results, electrolytes, liver and kidney function showed no significant changes after KD. No significant changes were observed in the sensation of light touch and pinprick. The average motor ASIA score increased from 33.3 to 35.1 after KD. Gastrointestinal dysfunction (diarrhea, nausea, poor appetite, gastric pain, and abdominal distension) was recorded in 5 patients, hypoglycemia occurred in one patient early after KD, and one patient experienced urticaria during KD. All the adverse reactions were relieved after symptomatic treatments.
Conclusion: This preliminary clinical trial demonstrated that KD could increase ketone bodies level and maintain a normal blood glucose level, suggesting its safety and feasibility in patients with acute SCI.