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Ketogenic Diet for Anorexia

N/A

Waitlist Available

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

Persons aged 16 to 45 years

Current anorexia nervosa diagnosis according to DSM-5 criteria

Must not have

Uncontrolled hypertension

Hepatic impairment (Class-Pugh b or c)

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, 6 month follow-up, 1 year follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is a 14-week study that aims to evaluate the effects of a ketogenic diet (TKD) on individuals with anorexia nervosa. A total of 120 participants will be recruited

Who is the study for?

This trial is for individuals aged 16-45 with anorexia nervosa who are in a partial hospital program or intensive outpatient treatment at the UCSD Eating Disorder Center. Participants will be followed up to twelve months after starting the study.

What is being tested?

The study compares a Therapeutic Ketogenic Diet (TKD) with standard treatment over 14 weeks. Forty participants will receive ketogenic meals, while twenty follow usual dietary treatments. The effects on mood, anxiety, and eating disorder symptoms will be monitored.

What are the potential side effects?

Potential side effects of the TKD may include changes in mood and anxiety levels due to diet alteration, as well as typical ketogenic diet side effects like flu-like symptoms during ketosis induction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 16 and 45 years old.

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I have been diagnosed with anorexia nervosa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not controlled by medication.

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My liver function is severely impaired.

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I have diabetes.

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My family has a history of porphyria.

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I have a neurocognitive disorder like dementia or symptomatic brain injury.

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, 6 month follow-up, 1 year 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, 6 month follow-up, 1 year 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, 6 month follow-up, 1 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Eating Restraint Score

Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score

Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Weight Concern Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic Ketogenic Diet (TKD) Study ArmExperimental Treatment1 Intervention

Participants in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet (TKD), weekly weight and ketone measurements, weekly behavioral assessments, and meetings with the study doctor and dietician every week, and peer counseling sessions.

Group II: Treatment as Usual (TAU) Study ArmActive Control1 Intervention

Participants who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks.

0 / 7Eligibility criteria met