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Ketone Supplementation in Eating Disorders

Primary Purpose

Anorexia Nervosa, Bulimia Nervosa, Atypical Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kenetik Ketone Drink
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketone Supplementation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
October 31, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05507008
Brief Title
Ketone Supplementation in Eating Disorders
Official Title
Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Bulimia Nervosa, Atypical Anorexia Nervosa, Atypical Bulimia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will complete 2-weeks daily ketone supplementation
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone Supplementation
Arm Type
Experimental
Arm Description
Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Kenetik Ketone Drink
Intervention Description
BHB supplementation
Primary Outcome Measure Information:
Title
Eating Disorders Inventory 3 Drive for Thinness Subscale
Description
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.
Time Frame
Change from baseline to study completion, up to 2 weeks
Title
Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale
Description
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.
Time Frame
Change from baseline to study completion, up to 2 weeks
Title
Weight Change
Description
Body Mass Index over time as a measure of food intake from the start to end of the study
Time Frame
Change in body mass index from baseline to study completion, up to 2 weeks]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Shott, BS
Phone
858-246-5272
Email
mshott@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan E Shott, BS
Phone
858-246-5272
Email
mshott@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD
Email
gfrank@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Guido Frank, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9797933
Citation
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.
Results Reference
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PubMed Identifier
34190963
Citation
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.
Results Reference
background
PubMed Identifier
19559687
Citation
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.
Results Reference
background
PubMed Identifier
28972576
Citation
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.
Results Reference
background
PubMed Identifier
30075165
Citation
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.
Results Reference
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Ketone Supplementation in Eating Disorders

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