Ketone Supplementation in Eating Disorders

NCT05507008 | Active Not Recruiting

• 1 other identifier: 804669
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Bulimia Nervosa; Atypical Anorexia Nervosa; Atypical Bulimia Nervosa

Outcome Measures

Primary Outcomes (3)

• Eating Disorders Inventory 3 Drive for Thinness Subscale

  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.

  Change from baseline to study completion, up to 2 weeks

• Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale

  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.

  Change from baseline to study completion, up to 2 weeks

• Weight Change

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

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

Study Arms (1)

Ketone Supplementation

EXPERIMENTAL

Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.

Dietary Supplement: Kenetik Ketone Drink

Interventions

Kenetik Ketone Drink DIETARY_SUPPLEMENT

BHB supplementation

Ketone Supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

Location

Related Publications (5)

• 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.

  PMID: 9797933 BACKGROUND

• 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.

  PMID: 34190963 BACKGROUND

• 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.

  PMID: 19559687 BACKGROUND

• 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.

  PMID: 28972576 BACKGROUND

• 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.

  PMID: 30075165 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Guido Frank, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All subjects will complete 2-weeks daily ketone supplementation

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)