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Therapeutic Ketogenic Diet in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa in Remission

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Ketogenic Diet
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 in Remission

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Persons, aged 18 to 45 years History of anorexia nervosa according to DSM-5 criteria Weight recovered at the time of study inclusion (body mass index > 17.5 kg/m2) Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers English is primary spoken language Exclusion Criteria: Pregnancy or lactation Electrolyte, blood count, kidney function or liver function abnormalities Psychosis Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria Uncontrolled hypertension Hepatic impairment (Class-Pugh b or c) Diabetes mellitus Family history of porphyria History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator Inability or unwillingness to adhere to the TKD diet for the duration of the study Blind or illiterate individuals

Sites / Locations

  • University of California San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Ketogenic Diet

Arm Description

A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter [mmol/L]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.

Outcomes

Primary Outcome Measures

To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered using weekly body weight measurements.
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered using the Committee of Clinical Investigations UKU-Side Effect Scale
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Measurement of the relationship between genotype and improvement of eating disorder symptoms
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
October 10, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT06000774
Brief Title
Therapeutic Ketogenic Diet in Anorexia Nervosa
Official Title
Ketogenic Diet in Weight Recovered Anorexia Nervosa to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (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 therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.
Detailed Description
For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 standard deviations above average) drive for thinness and body dissatisfaction and a high drive for food restriction and thus are at high risk for full relapse. Study participants will be carefully assessed and oriented to the ketogenic diet according to the procedures in our small previous trial (Calabrese, et al., 2022). The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting. A commercial supplier will provide the ketogenic diet. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms. Primary Objective 1 is to test the effects of ketogenic diet in individuals with anorexia nervosa who are weight recovered but continue to suffer severely from drive for thinness and are at very high relapse risk. Participants will be evaluated for tolerability of the study and weight trajectory. Primary Objective 2 is to assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 12-week course. Participants will be assessed for specific symptoms such as drive for thinness and body dissatisfaction, fear of eating and weight gain. Primary Objective 3 is to assess the underlying genetic basis for the treatment effect of the ketogenic diet.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will complete a 14-week therapeutic ketogenic diet (TKD)
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Ketogenic Diet
Arm Type
Experimental
Arm Description
A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter [mmol/L]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Therapeutic Ketogenic Diet
Intervention Description
therapeutic ketogenic diet
Primary Outcome Measure Information:
Title
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered using weekly body weight measurements.
Description
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
Time Frame
Weekly for the duration of the study intervention (14 weeks)
Title
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered using the Committee of Clinical Investigations UKU-Side Effect Scale
Description
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Time Frame
At weeks 4, 8, 12, 14
Title
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
Description
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Time Frame
At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up
Title
Measurement of the relationship between genotype and improvement of eating disorder symptoms
Description
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Persons, aged 18 to 45 years History of anorexia nervosa according to DSM-5 criteria Weight recovered at the time of study inclusion (body mass index > 17.5 kg/m2) Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers English is primary spoken language Exclusion Criteria: Pregnancy or lactation Electrolyte, blood count, kidney function or liver function abnormalities Psychosis Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria Uncontrolled hypertension Hepatic impairment (Class-Pugh b or c) Diabetes mellitus Family history of porphyria History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator Inability or unwillingness to adhere to the TKD diet for the duration of the study Blind or illiterate individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Shott, BS
Phone
848-246-5272
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
32848935
Citation
Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.
Results Reference
background
PubMed Identifier
31443880
Citation
Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.
Results Reference
background
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
17035265
Citation
Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.
Results Reference
background
PubMed Identifier
35997954
Citation
Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.
Results Reference
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Therapeutic Ketogenic Diet in Anorexia Nervosa

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