Clinical trial NCT03982602: Ketogenic Diet for Traumatic Brain Injury
Official title: Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Traumatic Brain Injury
Ketogenic Dieting
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Severe Traumatic Brain Injury
2. GCS\<= 8 with severe head injury
3. Age more than 18years

Exclusion Criteria:

1. Diabetic Ketoacidosis
2. Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)
3. Cardiorespiratory or hemodynamic instability
4. Coagulopathy
5. Pancreatitis
6. Liver Failure
7. Severe hyperlipidemia
8. Inability to tolerate enteral feeds including ileus
9. Known Fatty acid oxidation disorder or pyruvate carboxylase deficiency
10. Any terminally ill patient with poor brain stem reflexes and mortality within 24h of admission.
11. Pregnant Females

Primary outcomes:
measure: Effect of Ketogenic Diet on Intracranial Pressure
timeFrame: Baseline, till patient on KD (maximim 1 month)
measure: Development of Ketosis in blood
timeFrame: Baseline, till patient on KD ( maximum 1month)
measure: Excretion of Ketones in Urine
timeFrame: Baseline, till patient on KD (maximum 1 month)
Secondary outcomes:
measure: Evaluate change in the neurological exam
timeFrame: Baseline, before discharge from ICU
measure: Evaluate subjects with gastro-intestinal adverse effects
timeFrame: Baseline, till patient on KD (Maximum 1month)
measure: Evaluate subjects for muscle wasting
timeFrame: Baseline, till patient on Kd (Maximum 1month)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital
state: Missouri
Study officials:
References:
citation: Arora N, Litofsky NS, Golzy M, Aneja R, Staudenmyer D, Qualls K, Patil S. Phase I single center trial of ketogenic diet for adults with traumatic brain injury. Clin Nutr ESPEN. 2022 Feb;47:339-345. doi: 10.1016/j.clnesp.2021.11.015. Epub 2021 Nov 16.