Anorexia in Adolescence3D-EDNCT07726524
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
An observational study of Anorexia in Adolescence and Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 26 years
- Conditions the study is for
- Anorexia in Adolescence, Anorexia Nervosa, Anorexia Nervosa, Atypical
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to May 2031
- Phase
- Observational
- 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 15 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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).
Who may be able to join
- Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5
- Age 15 to 26 years
- Medical instability warranting an inpatient hospitalization defined by either:
- vital signs: daytime heart rate below 50 bpm or nighttime heart rate below 45 bpm, blood pressure below 90/50 mm Hg, temperature below 36 C, orthostatic increase in heart rate above 20 bpm or decrease in systolic blood pressure above 20 mm Hg or decrease in diastolic blood pressure above 10 mm Hg from lying to standing, or median BMI below 75 percent; or
- laboratory abnormality: AST above 40 IU/L, ALT above 30 IU/L, estimated GFR below 90 or cystatin C below 0.7 mg/L, albumin below 3.7 g/dL, or prealbumin below 20 mg/dL
- Extreme AN is defined as BMI below 15 kg/m2 or serious medical complications warranting admission to ACUTE (Denver Site).
Who cannot join
- Bulimia nervosa
- Another primary diagnosis causing malnutrition (not an eating disorder)
- Current active suicidality
- Metal implants or devices that interfere with study procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
ACUTE Center for Eating Disorders and Malnutrition at Denver Health
Denver, Colorado, 80204
Judy Oakes, PhD, 303-602-5093, judy.oakes@dhha.org
Marina Foster, BA, 303-602-1913, marina.foster@dhha.org
University of California, San Francisco Benioff Children's Hospital
San Francisco, California, 94158
Andrea K Garber, PhD, RD, 415-514-2180, andrea.garber@ucsf.edu
Arjun S Mehta, MPH, 415-476-8195, arjun.mehta@ucsf.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Anorexia in Adolescence, Anorexia Nervosa, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Anorexia Nervosa Restricting Type, Anorexia Nervosa With Significantly Low Body Weight
- Keywords
- Organ residual mass, Body composition, Three-dimensional optical imaging, Optical body scanning, Refeeding, Refeeding syndrome, Nutritional rehabilitation, Resting energy expenditure, Eating disorders, Bioelectrical impedance analysis, Fat-free mass, Adolescent, Young adult, Anorexia nervosa, Growth charts
- Medical subject headings
- Anorexia Nervosa, Bulimia, Malnutrition, Refeeding Syndrome, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission to medical stability, up to 4 weeks
Secondary outcomes (2)
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).
Measured: 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).
Measured: From hospital admission to post-refeeding assessment, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Denver Health and Hospital Authority, University of Hawaii
- Responsible party
- Sponsor
- Investigators
- Andrea K Garber, PhD, RD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726524
- Sponsor's protocol ID
- 1R01HD119553-01A1
- Other IDs
- 26-46188, R01HD119553
- Acronym
- 3D-ED
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
- ClinicalTrials.gov ID
- NCT07726524
- Acronym / sponsor ID
- 3D-ED / 1R01HD119553-01A1
- Conditions
- Anorexia in Adolescence, Anorexia Nervosa, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Anorexia Nervosa Restricting Type, Anorexia Nervosa With Significantly Low Body Weight
- Keywords
- Organ residual mass, Body composition, Three-dimensional optical imaging, Optical body scanning, Refeeding, Refeeding syndrome, Nutritional rehabilitation, Resting energy expenditure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Denver Health and Hospital Authority, University of Hawaii
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 24 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (6 listed)
- Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5
- Age 15 to 26 years
- Medical instability warranting an inpatient hospitalization defined by either:
- Extreme AN is defined as BMI below 15 kg/m2 or serious medical complications warranting admission to ACUTE (Denver Site).
Key exclusion criteria (4 listed)
- Bulimia nervosa
- Another primary diagnosis causing malnutrition (not an eating disorder)
- Current active suicidality
- Metal implants or devices that interfere with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)
Time frame: From hospital admission to medical stability, up to 4 weeks
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.
2 secondary outcomes
Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance
Time frame: Baseline (hospital admission)
Change in body composition during refeeding and medical/metabolic recovery
Time frame: From hospital admission to post-refeeding assessment, up to 4 weeks
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 24 Jul 2026.
- Individual participant dataSharing planned: 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.
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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.
Andrea K Garber, PhD, RD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia in Adolescence and Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jul 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. 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 Andrea K Garber, PhD, RD (415-514-2180, andrea.garber@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz) (time frame: From hospital admission to medical stability, up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.