Therapeutic Ketogenic Diet for Anorexia Nervosa
This study is looking at how safe and well-tolerated a Therapeutic Ketogenic Diet is for people with Anorexia Nervosa who are in a partial hospital program (PHP) or intensive outpatient program (IOP). The study will involve 60 participants, with 40 receiving the special diet and 20 receiving their usual care. Researchers will check your body weight weekly and use a questionnaire (UKU-Side Effect Scale) to track any side effects. They will also measure your drive for weight loss, fear of weight gain, and body image using another questionnaire (EDEQ Global Score) throughout the 14-week study and during follow-up. You may be able to join if you are between 16 and 45 years old and have an Anorexia Nervosa diagnosis. The study's current status is unclear.
- Study design
- This is a 14-week study with an open design, meaning both participants and researchers will know which treatment you are receiving. It aims to enroll 60 individuals, with 40 in the Therapeutic Ketogenic Diet group and 20 in the usual care group.
- What's involved
- You would participate in a 14-week study, with weekly body weight measurements and questionnaires at specific time points. You will also have a blood draw and genetic testing at the beginning of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 3 months, 6 months, and 1 year after the 14-week study period ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- To assess the safety and tolerability in individuals with anorexia nervosa who are in a high level of eating disorder treatment using weekly body weight measurements.Weekly for the duration of the study intervention (14 weeks)
Weekly weights will be obtained to assess whether subjects remain within the clinical goal weight range.
- To assess the safety and tolerability in individuals with anorexia nervosa who are in high level of eating disorder treatment using the Committee of Clinical Investigations UKU-Side Effect Scale (UKU Side Effect Rating Scale)At weeks 4, 8, 12
The UKU Side Effect Rating Scale assesses psychic, neurologic, autonomic, and other side effects on a scale of 0 to 3 where 0 = not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The global score ranges from 0 to 48 where a higher score indicates more side effects of the study intervention.
- Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global ScoreAt baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global scale has a range of 0 to 6 where higher scores mean worse outcome.
- Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Eating Restraint ScoreAt baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Restraint scale has a range of 0 to 6 where higher scores mean worse outcome.
- Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Weight Concern ScoreAt baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Weight concern scale has a range of 0 to 6 where higher scores mean worse outcome.