Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Keto Diet and PET Imaging in Anorexia Nervosa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ketogenic Diet in Weight Recovered Anorexia Nervosa to Normalize Brain Metabolism and Persistent Eating Disorder Psychopathology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a longitudinal study with an open design in weight recovered anorexia nervosa wrAN individuals Healthy controls HC will also be assessed Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose 18FFDG positron emission tomography PET scans for assessment of regional brain glucose uptake The wrAN group will be compared to healthy controls Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet TKD At the end of the TKD study participants will have assessments and a second 18FFDG and TMSEEG scan Study participants will be followed over six months after the intervention This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention This will be a naturalistic follow-up
Detailed Description:
Anorexia nervosa AN is a severe psychiatric disorder However neurobiological models and interventions to explain and treat the core characteristics of food restriction feeling fat and body size overestimation are lacking While research has made progress in understanding brain function involved in AN pathophysiology translating those results into biological therapies has been challenging Studies have suggested that metabolic factors contribute to developing and maintaining AN pathophysiology Specifically brain glucose utilization and metabolism may be altered in AN interfere with brain energy homeostasis and contribute to illness development and maintenance A small study indicated that ketosis might be therapeutic for AN core behaviors such as eating and shape concerns In this application the investigator will study individuals weight recovered from AN establish biological targets as diet-related metabolic markers for AN R61 phase and replicate and link those targets to AN-specific behaviors R33 phase The weight recovered AN group will also be compared with a healthy control sample The R61 Phase Specific Aim of the project is to establish target engagement for a therapeutic ketogenic diet TKD in AN after weight recovery and establish safety and tolerability It is hypothesized that TKD will be associated with reduced brain glucose metabolism using 18Ffluorodeoxyglucose 18FFDG and positron emission tomography PET target engagement Higher blood ketosis levels will be associated with a more significant reduction of the brain 18FFDG glucose metabolism rate dose dependency It is hypothesized that TKD will be well tolerated that participants will remain within the normal weight range tolerability and that study participants will be able to adhere to TKD as indicated by regular blood ketosis measurements treatment fidelity There will be an initial indication that TKD and associated biological measures correlate with behavioral measures derived from eating disorder-specific assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None