Clinical trial NCT05507008: Ketone Supplementation in Eating Disorders
Official title: Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Bulimia Nervosa
Atypical Anorexia Nervosa
Atypical Bulimia Nervosa
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will complete 2-weeks daily ketone supplementation
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.

Detailed description: The goals of the study are:

1) to test the effect of BHB as a nutritional supplement for AN and BN and 2) to test the ingestion of BHB on brain function.

Subjects will complete a battery of self-assessments and a diagnostic assessment in order to determine eligibility and for characterization of behavior to be used in later analyses. After eligibility is confirmed, subjects will complete 2 EEG scans on separate days after ingestion of Ketone supplement drink or placebo and will complete a taste reward task during the EEG scan. Subjects will then complete 2 weeks of daily ketone supplementation and self-assessments.

Eligibility criteria: Inclusion Criteria:

1. Must currently meet DSM-5 criteria for Anorexia Nervosa, Bulimia Nervosa, or OSFED Anorexia or Bulimia Nervosa based on the MINI diagnostic interview
2. Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
3. English as primary spoken language.
4. Ability to respond to EMA questions up to 6x per day within 60 minutes of receiving the message.

Exclusion Criteria:

1. Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
2. Current substance abuse or dependence in the past 3 months
3. Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
4. Medical conditions associated with ketoacidosis: type 1 diabetes mellitus, acute pancreatitis, alcoholic gastritis, peptic ulcer disease, hepatitis or Boerhaave syndrome (esophageal rupture)
5. History of significant head trauma
6. Indication of intellectual disability or autism spectrum disorder
7. Known allergy to any of the KenetikR drink components: D-beta-hydroxybutyric acid (D-BHB), Stevia, Monkfruit, Potassium Bicarbonate, Sodium Bicarbonate Potassium Sorbate or Taste Task Solutions: Sucrose, Potassium Chloride, Sodium bicarbonate.

Primary outcomes:
measure: Eating Disorders Inventory 3 Drive for Thinness Subscale
timeFrame: Change from baseline to study completion, up to 2 weeks
measure: Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale
timeFrame: Change from baseline to study completion, up to 2 weeks
measure: Weight Change
timeFrame: Change in body mass index from baseline to study completion, up to 2 weeks]
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Guido Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills IH, Park GR, Manara AR, Merriman RJ. Treatment of compulsive behaviour in eating disorders with intermittent ketamine infusions. QJM. 1998 Jul;91(7):493-503. doi: 10.1093/qjmed/91.7.493.
citation: Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580.
citation: Cheng B, Yang X, An L, Gao B, Liu X, Liu S. Ketogenic diet protects dopaminergic neurons against 6-OHDA neurotoxicity via up-regulating glutathione in a rat model of Parkinson's disease. Brain Res. 2009 Aug 25;1286:25-31. doi: 10.1016/j.brainres.2009.06.060. Epub 2009 Jun 25.
citation: Kokkinou M, Ashok AH, Howes OD. The effects of ketamine on dopaminergic function: meta-analysis and review of the implications for neuropsychiatric disorders. Mol Psychiatry. 2018 Jan;23(1):59-69. doi: 10.1038/mp.2017.190. Epub 2017 Oct 3.
citation: Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31.