Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Guido Frank, MD
Headshot of Guido Frank
Guido Frank

Description

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.

Official Title

Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders

Details

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.

Keywords

Anorexia Nervosa Bulimia Nervosa Atypical Anorexia Nervosa Atypical Bulimia Nervosa Anorexia Bulimia Feeding and Eating Disorders Kenetik Ketone Drink Ketone Supplementation

Eligibility

You can join if…

Open to people ages 18-65

  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.

You CAN'T join if...

  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.

Location

  • University of California San Diego accepting new patients
    San Diego California 92121 United States

Lead Scientist at UCSD

  • Guido Frank, MD
    Professor In Residence, Psychiatry, Vc-health Sciences-schools. Authored (or co-authored) 105 research publications. Research interests: Eating Disorders · Anorexia Nervosa · Bulimia Nervosa · Binge Eating Disorder · ARFID · Brain Imaging · Neuroscience · Treatment · Psychopharmacology · Psychotherapy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05507008
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated