Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT06605027
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form/parental permission form
2. Provision of signed and dated assent form if the subject is a minor
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. Persons, aged 16 to 45 years
5. Current anorexia nervosa diagnosis according to DSM-5 criteria
6. An elevated EDE-Q global score of 2.09 or greater
7. The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
8. English is primary spoken language
Exclusion Criteria:
1. Pregnancy or lactation
2. Electrolyte, blood count, kidney function or liver function abnormalities
3. Psychosis
4. Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
5. Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
6. Uncontrolled hypertension
7. Hepatic impairment (Class-Pugh b or c)
8. Diabetes mellitus
9. Family history of porphyria
10. History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
11. Inability or unwillingness to adhere to the TKD diet for the duration of the study
12. Blind or illiterate individuals
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
45 Years
Study:
NCT06605027
Study Brief:
Protocol Section:
NCT06605027