Ketogenic Diet for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— KETI  

Official title:

Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982602
• Other study ID #: 2014675
• Status: Completed
• Phase: Early Phase 1
• Start date: July 4, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ketogenic Dieting
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Missouri Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Ketogenic Diet on Intracranial Pressure	Intracranial Pressure will be measured hourly and it will be trended daily.	Baseline, till patient on KD (maximim 1 month)
Primary	Development of Ketosis in blood	Serum beta-hydroxybutyrate will be done alternate day to assess the level of ketosis in blood.	Baseline, till patient on KD ( maximum 1month)
Primary	Excretion of Ketones in Urine	Urine Ketones will be measured alternate day to assess the level of ketosis	Baseline, till patient on KD (maximum 1 month)
Secondary	Evaluate change in the neurological exam	Neurological exam will be documented with Glasgow Coma Scale.	Baseline, before discharge from ICU
Secondary	Evaluate subjects with gastro-intestinal adverse effects	Adverse effects like Diarrhea, vomiting, abdominal distension (ileus), abdominal tenderness will be monitored.	Baseline, till patient on KD (Maximum 1month)
Secondary	Evaluate subjects for muscle wasting	Urinary Nitrogen and urinary creatinine will be measured alternate day to look for muscle wasting.	Baseline, till patient on Kd (Maximum 1month)