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Ketogenic Diet for Anorexia

N/A

Recruiting

Led By Guido Frank, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up

Awards & highlights

Study Summary

This trial will look at how a ketogenic diet affects eating behaviors in people with anorexia who are weight-normalized but still have ED symptoms.

Who is the study for?

This trial is for individuals aged 18-45 with a history of anorexia nervosa, who are weight recovered (BMI > 17.5) but still exhibit eating disorder behaviors. Participants must speak English, consent to study procedures, and be able to take certain psychiatric medications if needed. Pregnant or breastfeeding individuals, those with certain medical conditions or substance use disorders, or those unable to follow the diet cannot participate.Check my eligibility

What is being tested?

The study examines how a therapeutic ketogenic diet affects eating behavior in people with anorexia nervosa who have normalized their weight yet struggle with body dissatisfaction and a high drive for thinness. It looks at mood changes and anxiety related to eating behaviors during the diet.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects of a therapeutic ketogenic diet may include fatigue, constipation, low blood sugar levels (hypoglycemia), nutrient deficiencies, and possible exacerbation of existing eating disorder symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Measurement of the relationship between genotype and improvement of eating disorder symptoms

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

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Therapeutic Ketogenic DietExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,024 Total Patients Enrolled

15 Trials studying Anorexia Nervosa

1,594 Patients Enrolled for Anorexia Nervosa

Guido Frank, MDPrincipal InvestigatorUniversity of California, San Diego

5 Previous Clinical Trials

455 Total Patients Enrolled

5 Trials studying Anorexia Nervosa

455 Patients Enrolled for Anorexia Nervosa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial allow for my participation?

"The requirements for enrollment in this medical trial are anorexia nervosa and age between 18 to 45 years. Up to 20 patients can be registered into the program."

Answered by AI

Does this experiment cater to individuals aged 30 or beyond?

"To be deemed fit for this study, one must satisfy the age-related requirement of being between 18 and 45 years old. Moreover, 38 studies are available to those under legal age while 36 others are devoted to seniors exceeding 65 years."

Answered by AI

Is enrollment in this trial still available?

"According to the data on clinicaltrials.gov, this research is actively seeking out participants; it was initially published on September 6th 2023 and recently updated on the same date."

Answered by AI

What is the upper limit of participants for this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was initially posted on September 6th 2023, is presently recruiting for participants. To date, the study has sought to enroll twenty individuals at a single medical centre."

Answered by AI

Recent research and studies

JAMA PsychiatryJournal

Association of Brain Reward Response with Body Mass Index and Ventral Striatal-hypothalamic Circuitry Among Young Women with Eating Disorders

Frank, Guido K. W., Megan E. Shott, Joel Stoddard, Skylar Swindle, and Tamara L. Pryor. 2021. “Association of Brain Reward Response with Body Mass Index and Ventral Striatal-hypothalamic Circuitry Among Young Women with Eating Disorders”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2021.1580.

clinicaltrials.govStudy

Therapeutic Ketogenic Diet in Anorexia Nervosa

Guido Frank 2023. "Therapeutic Ketogenic Diet in Anorexia Nervosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000774.

All > Anorexia Nervosa