Ketone Supplementation in Eating Disorders

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anorexia Nervosa, Bulimia Nervosa, Atypical Anorexia Nervosa, Atypical Bulimia Nervosa

Intervention / Treatment
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* Dietary Supplement: Kenetik Ketone Drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will complete 2-weeks daily ketone supplementation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone Supplementation<br>Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days. | Dietary Supplement: Kenetik Ketone Drink<br>* BHB supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] |