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

No Placebo-Only Group

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.

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.

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

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) 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

Awards & Highlights

No Placebo-Only Group

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

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.

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