Traumatic Brain InjuryEarly Phase 1KETINCT03982602
Ketogenic Diet for Traumatic Brain Injury
A Early Phase 1 study testing Ketogenic diet in people with Traumatic Brain Injury and Ketogenic Dieting, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Ketogenic Dieting
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2019to 30 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe Traumatic Brain Injury
- GCS<= 8 with severe head injury
- Age more than 18years
Who cannot join
- Diabetic Ketoacidosis
- Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)
- Cardiorespiratory or hemodynamic instability
- Coagulopathy
- Pancreatitis
- Liver Failure
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital
Columbia, Missouri, 65212
About this study
Official title: Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol
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.
Read the 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
- Being tested
- Ketogenic diet
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Also called Ketovie
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Ketogenic Diet on Intracranial Pressure
Intracranial Pressure will be measured hourly and it will be trended daily.
Measured: 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.
Measured: 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
Measured: Baseline, till patient on KD (maximum 1 month)
Secondary outcomes (3)
Evaluate change in the neurological exam
Neurological exam will be documented with Glasgow Coma Scale.
Measured: Baseline, before discharge from ICU
Evaluate subjects with gastro-intestinal adverse effects
Adverse effects like Diarrhea, vomiting, abdominal distension (ileus), abdominal tenderness will be monitored.
Measured: Baseline, till patient on KD (Maximum 1month)
Evaluate subjects for muscle wasting
Urinary Nitrogen and urinary creatinine will be measured alternate day to look for muscle wasting.
Measured: Baseline, till patient on Kd (Maximum 1month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start4 Jul 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niraj Arora, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982602
- Sponsor's protocol ID
- 2014675
- Acronym
- KETI
- Status last verified
- May 2024
- First submitted
- 3 Jun 2019
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35063224
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol
- ClinicalTrials.gov ID
- NCT03982602
- Acronym / sponsor ID
- KETI / 2014675
- Conditions
- Traumatic Brain Injury, Ketogenic Dieting
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects on Ketogenic diet | Experimental | Other: Ketogenic dietTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe Traumatic Brain Injury
- GCS<= 8 with severe head injury
- Age more than 18years
Key exclusion criteria (11 listed)
- Diabetic Ketoacidosis
- Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)
- Cardiorespiratory or hemodynamic instability
- Coagulopathy
- Pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietAlso: KetovieSubjects 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 | Subjects on Ketogenic diet |
Primary outcome
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.
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
3 secondary outcomes
Evaluate change in the neurological exam
Time frame: Baseline, before discharge from ICU
Evaluate subjects with gastro-intestinal adverse effects
Time frame: Baseline, till patient on KD (Maximum 1month)
Evaluate subjects for muscle wasting
Time frame: Baseline, till patient on Kd (Maximum 1month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 35063224Arora 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.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketogenic diet in people with Traumatic Brain Injury and Ketogenic Dieting, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Ketogenic Diet on Intracranial Pressure (time frame: Baseline, till patient on KD (maximim 1 month)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.