Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968638
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-07-12
Brief Title:
Ketogenic Diet in People With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Single-Blind Randomized Ketogenic Diet vs Control Diet in People With Schizophrenia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Schizophrenia is a serious mental disorder with a heterogenous presentation lack of clear understanding of pathophysiology and only partially effective treatments First-line antipsychotic drugs block dopamine but many people continue to suffer from persistent positive or negative symptoms that cannot be fully treated with available medications Recently our group has found that dietary modulations have efficacy comparable to antipsychotic medications and that determining which patients could benefit from a personalized treatment framework is critical
The ketogenic diet consists of low-carbohydrate moderate protein and high fat intake inducing a state in which ketone bodies in the blood provide energy to the cells In pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of normal behaviors independent of strict caloric restriction and other work has suggested that a ketogenic diet may improve schizophrenia like deficits in rodents An open label ketogenic diet study in the 1950s reported improvement in schizophrenia symptom At least 7 additional case reports have found robust improvements or complete resolution of schizophrenia symptoms Recently a retrospective study found robust and significant improvements in schizophrenia symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet In addition to psychiatric symptoms improvements in metabolic outcomes have been demonstrated However to date there have been no published double blind randomized controlled trials evaluating the effects of a ketogenic diet since few sites can conduct inpatient trials and have observation and control for food intake
The ketogenic diet consists of low-carbohydrate moderate protein and high fat intake inducing a state in which ketone bodies in the blood provide energy to the cells In pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of normal behaviors independent of strict caloric restriction and other work has suggested that a ketogenic diet may improve schizophrenia like deficits in rodents An open label ketogenic diet study in the 1950s reported improvement in schizophrenia symptom At least 7 additional case reports have found robust improvements or complete resolution of schizophrenia symptoms Recently a retrospective study found robust and significant improvements in schizophrenia symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet In addition to psychiatric symptoms improvements in metabolic outcomes have been demonstrated However to date there have been no published double blind randomized controlled trials evaluating the effects of a ketogenic diet since few sites can conduct inpatient trials and have observation and control for food intake
Detailed Description:
None
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