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Ketone Supplementation in Eating Disorders

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ClinicalTrials.gov Identifier: NCT05507008
Recruitment Status : Recruiting
First Posted : August 18, 2022
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Guido Frank, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE August 16, 2022
First Posted Date  ICMJE August 18, 2022
Last Update Posted Date November 2, 2022
Actual Study Start Date  ICMJE October 13, 2022
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketone Supplementation in Eating Disorders
Official Title  ICMJE Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All subjects will complete 2-weeks daily ketone supplementation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anorexia Nervosa
  • Bulimia Nervosa
  • Atypical Anorexia Nervosa
  • Atypical Bulimia Nervosa
Intervention  ICMJE Dietary Supplement: Kenetik Ketone Drink
BHB supplementation
Study Arms  ICMJE Experimental: Ketone Supplementation
Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.
Intervention: Dietary Supplement: Kenetik Ketone Drink
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2022)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Megan Shott, BS 858-246-5272 mshott@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05507008
Other Study ID Numbers  ICMJE 804669
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Guido Frank, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guido Frank, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP