Ketogenic Diet for Traumatic Brain Injury

NCT03982602 | Completed Early Phase 1

• 1 other identifier: 2014675
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Ketogenic Dieting

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Evaluate change in the neurological exam

  Baseline, before discharge from ICU

• Evaluate subjects with gastro-intestinal adverse effects

  Baseline, till patient on KD (Maximum 1month)

• Evaluate subjects for muscle wasting

  Baseline, till patient on Kd (Maximum 1month)

Study Arms (1)

Subjects on Ketogenic diet

EXPERIMENTAL

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.

Other: Ketogenic diet

Interventions

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.

Also known as: Ketovie

Subjects on Ketogenic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• 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.

  PMID: 35063224 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 11, 2019
• Study Start: July 4, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)