Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT04530032|
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2020
Last Update Posted : December 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: ketogenic diet Other: Standard diet||Not Applicable|
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated significant improvement in neurological or cognitive recovery. Changes in glucose metabolism are considered the hallmark metabolic response to TBI and ketosis has been proposed as a therapy to ameliorate metabolic dysfunction. Further research is necessary to address the outstanding questions regarding outcome, dose, timing, route and duration of ketogenic diet (KD) therapy in clinical TBI. Using a multiparametric MRI and MR spectroscopy approach in conjunction with standardized neurological and neuropsychological assessments of outcome, disability, cognition, and quality of life, this trial will investigate the therapeutic potential of a short term (14 day) KD on 6 month outcome following moderate-severe TBI patients.
The purpose of this project is to:
- Determine the effect of KD on cognitive and neurological outcome following moderate - severe TBI. To date clinical studies of ketone metabolism in TBI are severely limited and have focused primarily on ketometabolism and its effects on glucose metabolism without assessing functional or cognitive outcomes. This project directly assesses the effect of short-term KD on measures of disability, attention, memory, processing speed, language, and executive function during ketosis and will determine whether its effects outlast the duration of the diet.
- Identify the effect of KD on cerebral metabolism following moderate - severe TBI. While the use of ketogenic fuels is receiving greater attention, little is known about the effect of the KD on neuronal metabolism. This project will use MR spectroscopy to non-invasively measure NAA, a marker of neuronal metabolism during ketosis and outside the treatment window, which will deepen our understanding of the neuroprotective mechanisms of this therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury|
|Actual Study Start Date :||December 7, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: TBI KD
TBI subjects on a ketogenic diet
Other: ketogenic diet
short term (18 day) ketogenic/modified atkins diet use
Other Name: modified Atkins diet
Sham Comparator: TBI SD
TBI subjects on a standard (normal) diet
Other: Standard diet
standard (normal) diet use
- Neurological outcome [ Time Frame: day 0 to 6 months ]The Disability Rating Scale (DRS) will be used to measure general functional changes as a result of the dietary intervention over a 6 month recovery period. This scale ranges from 0 (without disability) to a maximum score of 29 (extreme vegetative state).
- Change in cerebral metabolism [ Time Frame: day 0 to 6 months ]Single voxel magnetic resonance spectroscopy will be used to assess changes in cerebral metabolism as a result of the dietary intervention.
- Neurocognitive outcome: Trail Making Test, Part B [ Time Frame: day 0 to 6 months ]A change in visual motor and visual spatial ability and mental flexibility as a result of the dietary intervention will be assessed over a 6 month period. Results are reported as the number of seconds required to complete the task with higher scores reveal greater impairment.
- Neurocognitive outcome: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: day 0 to 6 months ]
A change in cognitive improvement as a result of the dietary intervention will be assessed across 5 domains using the RBANS:
Immediate Memory - List learning and Story Memory Visuospacial/Constructional - Figure Copy and Line Orientation Language - Picture naming and Semantic Fluency Attention - Digit Span and Coding Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall The five domain scores are combined as a total scale score. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160.
- Neurocognitive outcome: Delis Kaplan Executive Function System (D-KEFS) [ Time Frame: day 0 to 6 months ]A change in executive function as a result of the dietary intervention will be assessed over a 6 month period using the verbal fluency and color word interference subtests of the D-KEFS. Achievement scores (total correct responses and total switching accuracy) will be measured using the D-KEFS Scoring Assistant software.
- Neurocognitive outcome: 36 Item Short Form Survey (SF-26) [ Time Frame: day 0 to 6 months ]Changes in quality of life as a result of the dietary intervention will be assessed over a 6 month period using the SF-36. Items are scored so that a high score defines a more favorable health state, with each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530032
|United States, California|
|Loma Linda University Health|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Brenda Bartnik-Olson, PhD||Loma LInda University Medical Center|
|Principal Investigator:||Duc Tran, MD||Loma LInda University Medical Center|