Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-06
First Post:
2020-08-11
Brief Title:
Ketogenic Diet Functional Recovery in Moderate to Severe Traumatic Brain Injury
Sponsor:
Loma Linda University
Organization:
Loma Linda University
Study Overview
Official Title:
Ketogenic Diet Functional Recovery in Moderate to Severe Traumatic Brain Injury
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 This trial investigates the therapeutic potential of a ketogenic or modified Atkins diet on neurocognitive outcome following moderate-severe TBI
Detailed Description:
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 or modified Atkins diet MAD 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 KDMAD on 12 month outcome following moderate-severe TBI patients
The purpose of this project is to
1 Determine the effect of KDMAD 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 KDMAD 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
2 Identify the effects of KDMAD 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 KDMAD 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
The purpose of this project is to
1 Determine the effect of KDMAD 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 KDMAD 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
2 Identify the effects of KDMAD 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 KDMAD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None