Ketogenic Diet for Traumatic Brain Injury (KETI)
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|ClinicalTrials.gov Identifier: NCT03982602|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Ketogenic Dieting||Drug: Ketogenic diet||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol|
|Actual Study Start Date :||July 4, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Subjects on Ketogenic diet
Treatment with KD will consist of 4:1 [fat]: [protein + carbohydrate] weight ratio. KD will be started as soon as the patient is ready for alimentation (while they are in neurocritical care unit). The rate of feeds will be calculated by trained dietician on service. Ketogenic diet will be continued during the entire length of ICU stay. Supplementation with vitamins, calcium and phosphorus will be done.
Drug: Ketogenic diet
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.
Other Name: Ketovie
- Effect of Ketogenic Diet on Intracranial Pressure [ Time Frame: Baseline, till patient on KD (maximim 1 month) ]Intracranial Pressure will be measured hourly and it will be trended daily.
- Development of Ketosis in blood [ Time Frame: Baseline, till patient on KD ( maximum 1month) ]Serum beta-hydroxybutyrate will be done alternate day to assess the level of ketosis in blood.
- Ketosis in CSF [ Time Frame: Baseline, till patient on KD (maximum 1 month) ]CSF Ketone level will be measured to look for brain ketotic state.
- Excretion of Ketones in Urine [ Time Frame: Baseline, till patient on KD (maximum 1 month) ]Urine Ketones will be measured alternate day to assess the level of ketosis
- Evaluate change in the neurological exam [ Time Frame: Baseline, before discharge from ICU ]Neurological exam will be documented with Glasgow Coma Scale.
- Evaluate subjects with gastro-intestinal adverse effects [ Time Frame: Baseline, till patient on KD (Maximum 1month) ]Adverse effects like Diarrhea, vomiting, abdominal distension (ileus), abdominal tenderness will be monitored.
- Evaluate subjects for abnormal Lipid profile [ Time Frame: Baseline, till patient on KD (Maximum 1month) ]Lipid panel will be done weekly to check for alteration in lipid profile while subjects on KD.
- Evaluate subjects for muscle wasting [ Time Frame: Baseline, till patient on Kd (Maximum 1month) ]Urinary Nitrogen and urinary creatinine will be measured alternate day to look for muscle wasting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982602
|United States, Missouri|
|University of Missouri Hospital||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Niraj Arora, MD 573-884-7975 ext 5738829500 firstname.lastname@example.org|
|Contact: Saurabh Kataria, MBBS 5738829500 ext 5738829500 email@example.com|