Anorexia NervosaNCT03100656
Study of Food Aversion in Patients With Anorexia Nervosa
A study testing A breakfast sandwich in people with Anorexia Nervosa, run by University of California, San Diego at 2 sites in 2 countries.
Trial summary
This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- A breakfast sandwich
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Nov 2016to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of >18.5 for at least one year.
- Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Nhien Nguyen, MS contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, 92037
P. Betty Shih, MPM, PhD, 858-534-0828, eatingdisorderresearch@ucsd.edu
Pei-an Betty Shih, MPM, PhD
Canada1 site, 1 recruiting
- Recruiting
Program for Eating Disorders, Toronto General Hospital
Toronto, Ontario
D. Blake Woodside, 416-340-4445, pbshih@ucsd.edu
D. Blake Woodside, MD FRCPC, 416-340-4445, pbshih@ucsd.edu
About this study
Official title: Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa
This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.
Read the detailed description
Anorexia nervosa is a brain-based disorder that often leads to serious health consequences including death. The EPHX2 gene has been identified as a susceptibility gene for anorexia nervosa. This study utilizes a multi-omics biomarker system approach to investigate how genetic factors interact with dietary factors to influence food aversion, psychopathology, and clinical outcome in patients with anorexia nervosa.
- Conditions
- Anorexia Nervosa
- Being tested
- A breakfast sandwich
- Keywords
- psychopathology, treatment, epoxide hydrolases, polyunsaturated fatty acids, eicosanoids
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A breakfast sandwichOther
A meat-based breakfast sandwich
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa I | Other | Anorexia nervosa with BMI <=17.5 kg/m² or BMI >17.5 kg/m² with regular binge-purge episodes Receives: Other: A breakfast sandwich |
| Anorexia nervosa II | Other | Anorexia nervosa with BMI > 18.5 kg/m² for at least 12 months. Receives: Other: A breakfast sandwich |
| Controls | Other | Healthy control women Receives: Other: A breakfast sandwich |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of metabolism biomarker
Percentage change of metabolism marker
Measured: 2 hours
Food aversion/anxiety
Percentage change of food aversion/anxiety score
Measured: 2 hours
Secondary outcomes (2)
Weight
Change in body weight, kg
Measured: 6 and 12 months
Psychopathology
Percentage change in eating disorder psychopathology score
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start10 Nov 2016
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of California, Davis
- Responsible party
- Principal investigator, Pei-an (Betty) Shih, University of California, San Diego
- Investigators
- Pei-an (Betty) Shih, MPM, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100656
- Sponsor's protocol ID
- R01MH106781
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2017
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shih PB. Integrating multi-omics biomarkers and postprandial metabolism to develop personalized treatment for anorexia nervosa. Prostaglandins Other Lipid Mediat. 2017 Sep;132:69-76. doi: 10.1016/j.prostaglandins.2017.02.002. Epub 2017 Feb 21.
PubMed 28232135Shih PA, Woodside DB. Contemporary views on the genetics of anorexia nervosa. Eur Neuropsychopharmacol. 2016 Apr;26(4):663-73. doi: 10.1016/j.euroneuro.2016.02.008. Epub 2016 Feb 20.
PubMed 26944296Shih PB, Yang J, Morisseau C, German JB, Zeeland AA, Armando AM, Quehenberger O, Bergen AW, Magistretti P, Berrettini W, Halmi KA, Schork N, Hammock BD, Kaye W. Dysregulation of soluble epoxide hydrolase and lipidomic profiles in anorexia nervosa. Mol Psychiatry. 2016 Apr;21(4):537-46. doi: 10.1038/mp.2015.26. Epub 2015 Mar 31.
PubMed 25824304Nguyen N, Dow M, Woodside B, German JB, Quehenberger O, Shih PB. Food-Intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa. Nutrients. 2019 Sep 13;11(9):2208. doi: 10.3390/nu11092208.
PubMed 31540208
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03100656
- Acronym / sponsor ID
- R01MH106781
- Conditions
- Anorexia Nervosa
- Keywords
- psychopathology, treatment, epoxide hydrolases, polyunsaturated fatty acids, eicosanoids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Toronto, University of California, Davis
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.
Detailed description
Anorexia nervosa is a brain-based disorder that often leads to serious health consequences including death. The EPHX2 gene has been identified as a susceptibility gene for anorexia nervosa. This study utilizes a multi-omics biomarker system approach to investigate how genetic factors interact with dietary factors to influence food aversion, psychopathology, and clinical outcome in patients with anorexia nervosa.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa I | Other | Other: A breakfast sandwichAnorexia nervosa with BMI <=17.5 kg/m² or BMI >17.5 kg/m² with regular binge-purge episodes |
| Anorexia nervosa II | Other | Other: A breakfast sandwichAnorexia nervosa with BMI > 18.5 kg/m² for at least 12 months. |
| Controls | Other | Other: A breakfast sandwichHealthy control women |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
- Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of >18.5 for at least one year.
- Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A breakfast sandwichA meat-based breakfast sandwich | Other | Anorexia nervosa I, Anorexia nervosa II, Controls |
Primary outcome
Change of metabolism biomarker
Time frame: 2 hours
Percentage change of metabolism marker
Food aversion/anxiety
Time frame: 2 hours
Percentage change of food aversion/anxiety score
2 secondary outcomes
Weight
Time frame: 6 and 12 months
Psychopathology
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 28232135Shih PB. Integrating multi-omics biomarkers and postprandial metabolism to develop personalized treatment for anorexia nervosa. Prostaglandins Other Lipid Mediat. 2017 Sep;132:69-76. doi: 10.1016/j.prostaglandins.2017.02.002. Epub 2017 Feb 21.
- Background: PubMed 26944296Shih PA, Woodside DB. Contemporary views on the genetics of anorexia nervosa. Eur Neuropsychopharmacol. 2016 Apr;26(4):663-73. doi: 10.1016/j.euroneuro.2016.02.008. Epub 2016 Feb 20.
- Background: PubMed 25824304Shih PB, Yang J, Morisseau C, German JB, Zeeland AA, Armando AM, Quehenberger O, Bergen AW, Magistretti P, Berrettini W, Halmi KA, Schork N, Hammock BD, Kaye W. Dysregulation of soluble epoxide hydrolase and lipidomic profiles in anorexia nervosa. Mol Psychiatry. 2016 Apr;21(4):537-46. doi: 10.1038/mp.2015.26. Epub 2015 Mar 31.
- Results publication: PubMed 31540208Nguyen N, Dow M, Woodside B, German JB, Quehenberger O, Shih PB. Food-Intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa. Nutrients. 2019 Sep 13;11(9):2208. doi: 10.3390/nu11092208.
- Food Aversion Study For Anorexia Nervosa at University of California, San DiegoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nhien Nguyen, MS contact
Pei-an (Betty) Shih, MPM, PhD principal investigator
University of California, San Diego
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A breakfast sandwich in people with Anorexia Nervosa, run by University of California, San Diego at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-an (Betty) Shih, MPM, PhD ((858) 534-0828, eatingdisorderresearch@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of metabolism biomarker (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100656, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.