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NCT Number: NCT05507008

Ketone Supplementation in Eating Disorders

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

San Diego, California, 92121, United States

About this study

The goals of the study are:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
  • Current substance abuse or dependence in the past 3 months
  • Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
  • Medical conditions associated with ketoacidosis: type 1 diabetes mellitus, acute pancreatitis, alcoholic gastritis, peptic ulcer disease, hepatitis or Boerhaave syndrome (esophageal rupture)
  • History of significant head trauma
  • Indication of intellectual disability or autism spectrum disorder
  • 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.

Treatment and study plan

Kenetik Ketone Drink

Dietary Supplement

BHB supplementation

Primary outcomes

  1. Eating Disorders Inventory 3 Drive for Thinness Subscale

    Time frame: Change from baseline to study completion, up to 2 weeks

    The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 28 where higher scores mean worse outcome.

  2. Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale

    Time frame: Change from baseline to study completion, up to 2 weeks

    The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 40 where higher scores mean worse outcome.

  3. Weight Change

    Time frame: Change in body mass index from baseline to study completion, up to 2 weeks]

    Body Mass Index over time as a measure of food intake from the start to end of the study

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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