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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have anorexia as diagnosed by DSM V, with a BMI between 11 and 17.5, or higher with symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of metabolism biomarker
Food aversion/anxiety
Secondary outcome measures
Psychopathology
Weight
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
693 Previous Clinical Trials
1,019,786 Total Patients Enrolled
2 Trials studying Anorexia Nervosa
242 Patients Enrolled for Anorexia Nervosa
University of California, DavisOTHER
914 Previous Clinical Trials
4,720,415 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,552,556 Total Patients Enrolled
15 Trials studying Anorexia Nervosa
1,314 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have anorexia as diagnosed by DSM V, with a BMI between 11 and 17.5, or higher with symptoms.I have or had anorexia but maintained a healthy weight for over a year.
Research Study Groups:
This trial has the following groups:- Group 1: Anorexia nervosa I
- Group 2: Anorexia nervosa II
- Group 3: Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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