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Therapeutic Ketogenic Diet in Anorexia Nervosa

A legfontosabb adatok

Ki végzi
University of California, San Diego
Hol
San Diego (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
20 fő, tervezett
Kezdés
2023. okt. 3.
Várható befejezés
2027. jún. 30.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Therapeutic Ketogenic Diet
A regiszteradat frissítve
2025. szeptember 5.

Ki vehet részt

Életkor
18 év – 45 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 60 feltétel megnézéseKevesebb

Egyéb feltételek

  • Weight-Recovered AN Inclusion Criteria:
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Persons, aged 18 to 45 years
  • History of anorexia nervosa according to DSM-5 criteria
  • Weight recovered at the time of study inclusion (body mass index > 17.5 kg/m2)
  • Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire
  • The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
  • English is primary spoken language; Weight-Recovered AN Exclusion Criteria:
  • Pregnancy or lactation
  • Electrolyte, blood count, kidney function or liver function abnormalities
  • Psychosis
  • Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
  • Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
  • Uncontrolled hypertension
  • Hepatic impairment (Class-Pugh b or c)
  • Diabetes mellitus
  • Family history of porphyria
  • History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
  • Inability or unwillingness to adhere to the TKD diet for the duration of the study
  • Blind or illiterate individuals; Underweight AN Sub-Study Inclusion Criteria:
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Persons, aged 18 to 45 years
  • Anorexia nervosa according to DSM-5 criteria
  • Current Body Mass Index (BMI) at the time of study inclusion of 16.0 to 17.49
  • An elevated EDE-Q global score of 2.09 or greater
  • The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
  • English is primary spoken language; Underweight AN Sub-Study Exclusion Criteria:
  • Pregnancy or lactation
  • Electrolyte, blood count, kidney function or liver function abnormalities
  • Psychosis
  • Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
  • Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
  • Uncontrolled hypertension
  • Hepatic impairment (Class-Pugh b or c)
  • Diabetes mellitus
  • Family history of porphyria
  • History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
  • Inability or unwillingness to adhere to the TKD diet for the duration of the study
  • Blind or illiterate individuals; Bulimia Nervosa Pilot Inclusion Criteria:
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Persons, aged 18 to 45 years
  • History of bulimia nervosa according to DSM-5 criteria
  • An elevated EDE-Q global score of 2.09 or greater
  • The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
  • English is primary spoken language; Bulimia Nervosa Pilot Exclusion Criteria:
  • Pregnancy or lactation
  • Electrolyte, blood count, kidney function or liver function abnormalities
  • Psychosis
  • Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
  • Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
  • Uncontrolled hypertension
  • Hepatic impairment (Class-Pugh b or c)
  • Diabetes mellitus
  • Family history of porphyria
  • History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
  • Inability or unwillingness to adhere to the TKD diet for the duration of the study
  • Blind or illiterate individuals

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 45 év között vagy?

Helyszínek itt: Egyesült Államok

  • University of California San DiegoSan Diego, Egyesült ÁllamokContact: Megan E Shott, BSRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.

A teljes eredeti leírásKevesebb

The Underweight Anorexia Nervosa (AN) Sub-Study will investigate the effects of TKD on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who are currently underweight (body mass index between 16.0 and 17.49) and continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.

The Bulimia Nervosa Pilot will will investigate the effects of TKD on eating behavior including drive to binge and purge, body dissatisfaction, mood and anxiety in individuals with bulimia nervosa.

A vizsgálat csoportja

  • Therapeutic Ketogenic DietA vizsgált kezelés

    A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter \[mmol/L\]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
Illeszkedési kérdések
Forrás: NCT06000774: ki vehet részt
Publikációk
A regiszteradat frissítve
2025. szeptember 5.