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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Bulimia Nervosa Atypical Anorexia Nervosa Atypical Bulimia Nervosa Dietary Supplement: Kenetik Ketone Drink Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders
Actual Study Start Date : October 13, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketone Supplementation
Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.
 Dietary Supplement: Kenetik Ketone Drink
BHB supplementation


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05507008


Contacts
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Contact: Megan Shott, BS 858-246-5272 mshott@health.ucsd.edu

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Megan E Shott, BS    858-246-5272    mshott@health.ucsd.edu   
Contact: Guido Frank, MD       gfrank@health.ucsd.edu   
Principal Investigator: Guido Frank, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Guido Frank, MD University of California, San Diego
More Information
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Publications:

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Responsible Party: Guido Frank, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05507008    
Other Study ID Numbers: 804669
First Posted: August 18, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
 Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Hyperphagia