Ketogenic Diet for Traumatic Brain Injury

NCT ID: NCT03982602

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2024-04-30

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.

Conditions

Traumatic Brain Injury; Ketogenic Dieting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Ketovie

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Niraj Arora

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Missouri Hospital

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35063224 (View on PubMed)

Other Identifiers

2014675

Identifier Type: -

Identifier Source: org_study_id