Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.
Traumatic Brain Injury (TBI) is a major health concern for United States contributing nearly one-third of injury-related deaths in United States. The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million people in the United States sustain a TBI each year. It is responsible for significant disabilities and the total cost of productivity loss was estimated to be $76.5 billion in the United States in 2004. Several animal models have demonstrated the effectiveness of ketones in brain injury to decrease the size of contusion, improving cortical ATP levels, reduced brain edema and cellular apoptosis. Ketones have been shown to be effective in neuromodulation in animal models. Evaluation of carbohydrate free diet has been done in traumatic brain injury patients and it was noted to not cause fluctuations in blood glucose. There is a need for safety and feasibility study of ketogenic diet in traumatic brain injury patients and to understand the effectiveness in neuromodulation in humans. The present study focuses on identifying the safety and feasibility of KD in traumatic brain injury patients. This pilot project data will be utilized to design future randomized clinical trials. Based on the safety data, further trials will be conducted to evaluate the effectiveness of KD in traumatic brain injury patients and its effectiveness in controlling elevated intracranial pressure. It will open the avenue for consideration of new treatment option for intracranial pressure management and functional recovery. From a nutrition perspective, Ketogenic diet might become the standard of care for this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subjects will be provided with the Ketogenic diet in the form of tube feeds once the decision is made to start the patient on diet.
University of Missouri Hospital
Columbia, Missouri, United States
Effect of Ketogenic Diet on Intracranial Pressure
Intracranial Pressure will be measured hourly and it will be trended daily.
Time frame: Baseline, till patient on KD (maximim 1 month)
Development of Ketosis in blood
Serum beta-hydroxybutyrate will be done alternate day to assess the level of ketosis in blood.
Time frame: Baseline, till patient on KD ( maximum 1month)
Excretion of Ketones in Urine
Urine Ketones will be measured alternate day to assess the level of ketosis
Time frame: Baseline, till patient on KD (maximum 1 month)
Evaluate change in the neurological exam
Neurological exam will be documented with Glasgow Coma Scale.
Time frame: Baseline, before discharge from ICU
Evaluate subjects with gastro-intestinal adverse effects
Adverse effects like Diarrhea, vomiting, abdominal distension (ileus), abdominal tenderness will be monitored.
Time frame: Baseline, till patient on KD (Maximum 1month)
Evaluate subjects for muscle wasting
Urinary Nitrogen and urinary creatinine will be measured alternate day to look for muscle wasting.
Time frame: Baseline, till patient on Kd (Maximum 1month)
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