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Completed

NCT Number: NCT03982602

Ketogenic Diet for Traumatic Brain Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri Hospital

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe Traumatic Brain Injury
  • GCS<= 8 with severe head injury
  • Age more than 18years

Exclusion criteria

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

Treatment and study plan

Ketogenic diet

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.

Other names: Ketovie

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. Evaluate change in the neurological exam

    Time frame: Baseline, before discharge from ICU

    Neurological exam will be documented with Glasgow Coma Scale.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Acronym: KETI

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2019
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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