An observational study in Anorexia in Adolescence, Anorexia Nervosa and Anorexia Nervosa, Atypical, sponsored by University of California, San Francisco. Not yet recruiting at 2 sites in United States. Open to participants aged 15 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University of California, San Francisco · Observational
Among 173 studies in Anorexia Nervosa with a site in United States — 36 open to participants now, 45 under way, none of them phase 3. Anorexia Nervosa · United States.
Among the 173 studies in Anorexia Nervosa with a site in United States, this one is the 11th largest by planned enrollment of the 31 observational ones that give a count, is one of 3 that started in 2027, is one of 31 observational ones, reaches primary completion later than 44 of the 44 other live ones, and was the 170th registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
Browse Anorexia Nervosa studies →36 of the 173 studies in Anorexia Nervosa with a site in United States are open now. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Trustees of Dartmouth College · Sites in United States
Milton S. Hershey Medical Center · Sites in United States
Massachusetts General Hospital · Sites in United States
Milton S. Hershey Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 15 Years to 26 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
173 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 26 · Phase 3 8 · Phase 4 5
First in 2000; this study’s year is marked. 3 started in 2027.
This study's planned enrollment of 90 is above the median of 78 across 142 observational studies indexed under Anorexia Nervosa.
Median enrollment 40 across the 142 interventional studies, 66 across the 31 observational. Of the 122 that completed or were terminated, 34 (28%) have results posted.
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4 of 173 have an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
University of California, San Francisco has 6 studies filed under Anorexia Nervosa — fewer than ten, so there is no comparison to draw.
20 of the studies in Anorexia Nervosa with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT05509257Children's Mercy Hospital Kansas CityNaltrexone Neuroimaging in Teens With Eating Disorders | 2026-12 |
| NCT04583774University of California, San DiegoDeveloping an EEG Paradigm to Study Prediction Error in Anorexia Nervosa | 2026-12 |
| NCT05197309Icahn School of Medicine at Mount SinaiMetabolic Diet for Relapse Prevention in Anorexia Nervosa | 2026-12 |
| NCT05170919Englewood Hospital and Medical CenterComparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer | 2026-12 |
Among the 173 studies in Anorexia Nervosa with a site in United States, from their registry updates:
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People with anorexia nervosa often become medically unstable because of severe malnutrition and require hospitalization for nutritional rehabilitation. Clinicians currently rely heavily on body weight to assess malnutrition, but body weight does not always reflect the severity of illness. This study will use infrared scanning to assess body composition in adolescents and young adults hospitalized with anorexia nervosa. Researchers will then examine how organ and tissue stores relate to the degree of malnutrition, predict nutritional needs and medical restoration in hospital, and recovery outcomes over the following year. The goal is to develop more individualized approaches to nutritional rehabilitation and improve recovery for individuals with malnutrition due to eating disorders.
Background: The proposed project is aligned with NIH's Strategic Plan for Nutrition Research (SPNR) Objectives 4-2 and 4-3, to reduce the burden of malnutrition in clinical settings. Up to 40% of patients with anorexia nervosa (AN) become medically unstable due to malnutrition and require hospitalization for refeeding; 25% progress to severe and enduring illness. Long, intensive hospitalizations with frequent readmissions drive high healthcare costs in AN. Historically, clinicians have relied on body weight to assess malnutrition and response to intervention. However, body weight lost diagnostic power due to rising BMIs. About one third of patients today are diagnosed with atypical AN (AAN), with medical instability at "normal" weight. The upward shift in BMI is reflected globally, leading new recommendations to include body composition to diagnose malnutrition. Emphasis is on low fat free mass (FFM) as a predictor of poor hospital outcomes. However, this has not been examined in hospitalized patients with AN, who are often too medically unstable to transport for research scans. This gap can now be filled with whole-body, infrared, 3-dimensional optical imaging (3DO) at the bedside. Prior work by the investigators showed excellent concordance between 3DO and dual X-ray absorptiometry (DXA) for detecting malnutrition at low BMI and captured changes in FFM with bedside 3DO during refeeding. Proposed project: The investigators will employ a functional approach to body composition, integrating compartment mass with physiologic function, to assess malnutrition and predict short-term and long-term refeeding outcomes across the malnutrition continuum. Prior research on FFM has focused on the skeletal muscle and bone components and long-term risks in AN. In contrast, organ residual mass (ORM), which comprises 43% of FFM, has received little attention despite its central role in refeeding. Profound ORM depletion in AN (loss of 43% cardiac, 22% renal, and 39% hepatic mass) contributes to organ dysfunction, hypometabolism, and refeeding complications. The investigators will generate ORM reference values from large, representative datasets, calculate ORM index z-scores (ORMIz), and examine their correlation with malnutrition at baseline, in response to short-term refeeding intensity, and as a predictor of long-term outcomes in patients across the continuum of malnutrition due to AN. Purpose, hypotheses and design: This multicenter, prospective, observational study will include N=90 hospitalized 15 to 26 year olds with medical instability and malnutrition due to AAN, AN, or extreme AN.
Aim 1) Assess clinical utility of ORMIz at admission. Lower baseline ORMIz will: H1) correlate with malnutrition markers, H2) correlate with pre-admission energy imbalance, and H3-Primary) predict refeeding intensity.
Aim 2) Monitor response to refeeding in hospital. Change in ORM will correlate with: H1) medical stability, H2) metabolic stability, and H3) lower baseline FM.
Aim 3) Predict long-term outcomes. Lower discharge ORMIz will predict poor outcomes at 3, 6, 9, and 12 months. Findings will be rapidly translated into individualized refeeding approaches.
Adolescents and young adults ages 15 to 26 hospitalized with medical instability and malnutrition due to atypical anorexia nervosa, anorexia nervosa, or extreme anorexia nervosa, enrolled at admission at two clinical sites (UCSF Benioff Children's Hospital and the ACUTE Center for Eating Disorders and Malnutrition at Denver Health).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Medical instability warranting an inpatient hospitalization defined by either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)
Total caloric load required to restore medical stability during hospitalization, analyzed as a function of baseline organ residual mass index z-score (ORMIz). Primary hypothesis (Aim 1, H3): lower baseline ORMIz predicts greater refeeding intensity, including higher caloric load and more refeeding complications such as edema and electrolyte shifts. This is the endpoint on which the study is powered.
Time frame: From hospital admission to medical stability, up to 4 weeks
Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance
Association of baseline organ residual mass index z-score (ORMIz) with (a) markers of malnutrition (body composition, grip strength, Nutrition Risk Score), medical instability (vital signs, organ function, cardiac mass), and hypometabolism (resting energy expenditure and hormonal markers) (Aim 1, H1); and (b) pre-admission energy imbalance (intake minus expenditure), evaluated independent of BMI (Aim 1, H2).
Time frame: Baseline (hospital admission)
Change in body composition during refeeding and medical/metabolic recovery
Change in organ residual mass (ORM), fat-free mass, and fat mass from admission through refeeding, and its association with improvement in medical stability (H1) and hypometabolism (H2), plus the relationship of ORM change to lower baseline fat mass (H3) (Aim 2).
Time frame: From hospital admission to post-refeeding assessment, up to 4 weeks
Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)
Post-refeeding from hospitalizations' (hospital duration approximately 1 to 4 weeks) association with ORMIz with long-term outcomes, including eating disorder psychopathology and behaviors (EDE-Q), need for higher levels of care such as residential treatment, and eating-disorder-related rehospitalization (Aim 3).
Time frame: 3, 6, 9, and 12 months after hospital discharge
Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)
Post-refeeding from hospitalizations' (hospital duration approximately 1-4 weeks) association with ORMIz with long-term outcomes, including eating disorder psychopathology and behaviors (EDE-Q), need for higher levels of care such as residential treatment, and eating-disorder-related rehospitalization (Aim 3).
Time frame: 3, 6, 9, and 12 months after hospital discharge
Plan to share: Yes — De-identified individual participant data underlying the published results will be shared, together with the study protocol, statistical analysis plan, and informed consent form.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available no later than one year after the end of the follow-up period (March 2032) or at the time of associated publications, whichever occurs first, and will remain available through the repository thereafter.
Access criteria: Data will be made available via the NIH Data and Specimen Hub (DASH) Repository after the study completion.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for May 2031, 52 months later.
Of 56 non-industry observational studies under Anorexia Nervosa, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 72. This study's planned 52 months is above that.
Counting every sponsor, half of 56 studies reached it within 38 months; a quarter within 16 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco →