Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605027
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Therapeutic Ketogenic Diet in Partial Hospital Program PHP Anorexia Nervosa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Therapeutic Ketogenic Diet to Treat Anorexia Nervosa-Specific Cognitions and Behaviors - Currently Ill Individuals in PHP Level of Care and Comparison with Standard of Care
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 will be a 14-week longitudinal study with an open design A total of 120 individuals will be recruited for an end goal of 60 individuals with anorexia nervosa AN who are currently in high level of care treatment at the UCSD Eating Disorder Center partial hospital program PHP or intensive outpatient IOP Forty individuals will be recruited to the TKD and 20 will be treated with treatment as usual with respect to food intake The age range will be between 16 and 45 years All study participants will be carefully assessed and will complete rater and self-assessments at the being at the end of the study period While in the treatment program the TKD group will receive catered ketogenic meals via a meal service After discharging from program participants will have the option to continue with the meal service or cook for themselves After establishing ketosis study participants will continue TKD for 12 weeks All study participants will be followed over three six and twelve months after enrolling in the study whether initiating TKD or being in the treatment as usual arm This follow-up procedure will help determine whether symptom improvement is stable or worsens in individuals who choose to continue or discontinue the TKD intervention and in relation to the control group After ketosis induction over two weeks study participants will be assessed weekly for ketosis and mood anxiety and eating disorder symptoms over twelve weeks
Detailed Description:
For this 14-week study 60 individuals with anorexia nervosa AN who are currently in high level of care treatment at the UC San Diego Health Eating Disorders Center for Treatment and Research UC San Diego Health EDC partial hospitalization program PHP or IOP will be recruited These individuals will be underweight or recently weight-restored and continue to have high impairment from the illness as indicated by an Eating Disorder Examination Questionnaire EDE-Q global score greater than 209
Of those 60 participants 40 of them will participate in the Therapeutic Ketogenic Diet TKD Study Arm and 20 subjects will be enrolled in the Treatment as Usual Study Arm The study will be conducted in a university medical environment showing feasibility and safety in a typical medical setting
After completing the screening steps all participants will complete a blood draw and genetics testing
AN subjects will be given the option to participate in the TKD Study Arm or the Treatment as Usual Study Arm Recruitment in each arm will continue until the end recruitment enrollment goal for each arm has been reached Subjects will not be randomized to the study arm and will be given a choice of what arm they want to participate in Subjects who consent to be in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet TKD weekly weight and ketone measurements weekly behavioral assessments and meetings with the study doctor and dietician every week and peer counseling sessions While in the treatment program the TKD group will receive catered ketogenic meals via a meal service After discharging from program participants will have the option to continue with the meal service or cook for themselves
AN subjects who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks
After discharge from the PHP program subjects will continue to be monitored virtually for the study procedures
In the last week of the therapeutic ketogenic diet week 14 all AN subjects will complete another blood draw and the exit visit with the study doctor and dietician
AN subjects will complete follow-up visits 3 months 6 months and 1 year after the 14-week completion date
Of those 60 participants 40 of them will participate in the Therapeutic Ketogenic Diet TKD Study Arm and 20 subjects will be enrolled in the Treatment as Usual Study Arm The study will be conducted in a university medical environment showing feasibility and safety in a typical medical setting
After completing the screening steps all participants will complete a blood draw and genetics testing
AN subjects will be given the option to participate in the TKD Study Arm or the Treatment as Usual Study Arm Recruitment in each arm will continue until the end recruitment enrollment goal for each arm has been reached Subjects will not be randomized to the study arm and will be given a choice of what arm they want to participate in Subjects who consent to be in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet TKD weekly weight and ketone measurements weekly behavioral assessments and meetings with the study doctor and dietician every week and peer counseling sessions While in the treatment program the TKD group will receive catered ketogenic meals via a meal service After discharging from program participants will have the option to continue with the meal service or cook for themselves
AN subjects who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks
After discharge from the PHP program subjects will continue to be monitored virtually for the study procedures
In the last week of the therapeutic ketogenic diet week 14 all AN subjects will complete another blood draw and the exit visit with the study doctor and dietician
AN subjects will complete follow-up visits 3 months 6 months and 1 year after the 14-week completion date
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