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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TorontoOTHER

689 Previous Clinical Trials

1,018,343 Total Patients Enrolled

2 Trials studying Anorexia Nervosa

242 Patients Enrolled for Anorexia Nervosa

University of California, DavisOTHER

911 Previous Clinical Trials

4,709,283 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,107 Total Patients Enrolled

15 Trials studying Anorexia Nervosa

1,314 Patients Enrolled for Anorexia Nervosa

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

Frequently Asked Questions

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

Is it possible for me to register in this clinical experiment?

"To be eligible to join this anorexia nervosa trial, participants must aged between 18 and 55. Approximately 300 patients are sought after for enrolment."

Answered by AI

How many people are currently enrolled in this clinical experiment?

"Affirmative. According to the information held on clinicaltrials.gov, participant recruitment for this medical investigation is still in progress. The trial was launched on November 10th 2016 and updated lastly on August 3rd 2022; with a need of 300 individuals across one medical facility."

Answered by AI

Does this research accept participants aged eighty-five and beyond?

"This research necessitates volunteers aged 18 to 55. There are 38 distinct studies that involve minors and 33 trials specialized for those over the age of 65."

Answered by AI

Are new participants currently being enrolled in this experiment?

"That is accurate. According to clinicaltrials.gov, this trial commenced on November 10th 2016 and has since been actively enrolling 300 patients at one centre. The most recent update was published on August 3rd 2022."

Answered by AI

Recent research and studies

NutrientsJournal

Food-intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa

Nguyen, Nhien, Michelle Dow, Blake Woodside, J. Bruce German, Oswald Quehenberger, and Pei-an Betty Shih. 2019. “Food-intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa”. Nutrients. MDPI AG. doi:10.3390/nu11092208.

Prostaglandins & Other Lipid MediatorsJournal

Integrating Multi-omics Biomarkers and Postprandial Metabolism to Develop Personalized Treatment for Anorexia Nervosa

Shih, Pei-an Betty. 2017. “Integrating Multi-omics Biomarkers and Postprandial Metabolism to Develop Personalized Treatment for Anorexia Nervosa”. Prostaglandins & Other Lipid Mediators. Elsevier BV. doi:10.1016/j.prostaglandins.2017.02.002.

European NeuropsychopharmacologyJournal

Contemporary Views on the Genetics of Anorexia Nervosa

Shih, Pei-an Betty, and D. Blake Woodside. 2016. “Contemporary Views on the Genetics of Anorexia Nervosa”. European Neuropsychopharmacology. Elsevier BV. doi:10.1016/j.euroneuro.2016.02.008.

Molecular PsychiatryJournal