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Dietary Intervention for Anorexia Nervosa

N/A
Recruiting
Led By Pei-an (Betty) Shih, MPM, PhD
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
Ill AN subjects will meet current Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis of AN, body mass index (BMI) between 11 kg/m² and 17.5 kg/m², or BMI > 17.5 kg/m² with active eating disorder symptoms.
Be between 18 and 65 years old
Must not have
Exclusion criteria for AN and control subjects include: Organic brain syndrome, schizophrenia and schizoaffective disorder, untreated thyroid disease, renal disease, hepatic disease, and the regular use of fish-oil containing supplements within the last three months of the study. All pregnant and lactating individuals will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well people with anorexia nervosa process food compared to healthy controls, in order to develop more effective treatments.

Who is the study for?
This trial is for individuals with anorexia nervosa (AN), including those who have recovered or are currently ill. Recovered participants should have a BMI of 18.5-30 and maintained it for at least a year, while ill participants must meet the DSM V criteria for AN with certain BMI limits. Healthy controls without psychiatric illnesses and stable BMIs are also eligible. People with serious mental health issues, untreated thyroid, kidney or liver diseases, fish-oil supplement use in recent months, or who are pregnant/lactating cannot join.
What is being tested?
The study is testing how people with anorexia nervosa metabolize food by having them eat a breakfast sandwich and comparing their responses to healthy controls. It aims to understand the role of genetics and biochemistry in food metabolism within this population to improve treatment approaches.
What are the potential side effects?
Since the intervention involves eating a standard breakfast sandwich, there may not be typical 'side effects' like in drug trials; however, individuals with AN might experience psychological discomfort or stress related to eating challenges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have anorexia as diagnosed by DSM V, with a BMI between 11 and 17.5, or higher with symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe mental health issues, untreated thyroid, kidney or liver diseases, and haven't used fish-oil supplements recently. I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change of metabolism biomarker
Food aversion/anxiety
Secondary study objectives
Psychopathology
Weight

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: ControlsExperimental Treatment1 Intervention
Healthy control women
Group II: Anorexia nervosa IIExperimental Treatment1 Intervention
Anorexia nervosa with BMI \> 18.5 kg/m² for at least 12 months.
Group III: Anorexia nervosa IExperimental Treatment1 Intervention
Anorexia nervosa with BMI \<=17.5 kg/m² or BMI \>17.5 kg/m² with regular binge-purge episodes

Find a Location

Who is running the clinical trial?

University of TorontoOTHER
725 Previous Clinical Trials
1,115,392 Total Patients Enrolled
2 Trials studying Anorexia Nervosa
242 Patients Enrolled for Anorexia Nervosa
University of California, DavisOTHER
946 Previous Clinical Trials
4,755,830 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,441 Total Patients Enrolled
18 Trials studying Anorexia Nervosa
1,605 Patients Enrolled for Anorexia Nervosa
Pei-an (Betty) Shih, MPM, PhDPrincipal Investigator - University of California, San Diego
University of California, San Diego

Media Library

Meal-challenge protocol Clinical Trial Eligibility Overview. Trial Name: NCT03100656 — N/A
Anorexia Nervosa Research Study Groups: Anorexia nervosa I, Anorexia nervosa II, Controls
Anorexia Nervosa Clinical Trial 2023: Meal-challenge protocol Highlights & Side Effects. Trial Name: NCT03100656 — N/A
Meal-challenge protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03100656 — N/A
~15 spots leftby Jun 2025