ClinicalTrials.gg
CompletedNCT06800742COCOMETANNERUpdated Nov 6, 2026

Body Composition in Adolescents With Anorexia Nervosa

An observational study in Anorexia Nervosa, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to female participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Istituto Auxologico Italiano · Observational

Updated Nov 6, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
32
Ages
12 Years to 18 Years
Sex
Female
01

Study summary

Body Mass Index (BMI) is currently the most widely recommended parameter for identifying underweight subjects. Among eating disorder diseases, anorexia nervosa (AN) is the one with the highest mortality rate and with relapses between 12 and 27%. To date, recovery programs allow approximately 40% of subjects to achieve recovery, 30% demonstrate improvements, and 20% remain chronically affected. These data demonstrate the importance of continuously monitoring changes in weight and body composition of these subjects. Bioelectrical impedance (BIA) is widely used to determine body composition in AN. BIA provides various parameters, such as lean mass (LM), fat mass (FM), total body water (TBW), and phase angle (PhA). Among these parameters, in addition to LM and FM, PhA has also been used to characterize underweight subjects with AN. In addition to the observed relationship between PhA and body composition in individuals with AN, PhA has also been related to the basal metabolic rate (BMR). BMR undergoes changes mainly due to loss of muscle mass and a significant reduction in BMR has been observed in AN subjects. Finally, physical activity represents a significant determinant of body composition and can help regulate BMR.

Therefore, monitoring changes in body composition (LM, FM, and PhA) and indirect indices (lean mass index and fat mass index) using BIA, together with monitoring changes in BMR and physical activity level, could provide important support for the continuous control and definition of the clinical stage of the disease in patients with AN.

The aim of this study is to determine body composition, basal metabolic rate, and level of physical activity in Anorexia Nervosa and normal weight subjects to identify the most consistent parameters to define the clinical stage of the disease in subjects with AN.

Read the detailed description

Body Mass Index (BMI) is currently the most widely recommended parameter for identifying underweight subjects. Among eating disorder diseases, anorexia nervosa (AN) is the one with the highest mortality rate and with relapses between 12 and 27%. To date, recovery programs allow approximately 40% of subjects to achieve recovery, 30% demonstrate improvements, and 20% remain chronically affected. These data demonstrate the importance of continuously monitoring changes in weight and body composition of these subjects. Bioelectrical impedance (BIA) is widely used to determine body composition in AN. BIA provides various parameters, such as lean mass (LM), fat mass (FM), total body water (TBW), and phase angle (PhA). Among these parameters, in addition to LM and FM, PhA has also been used to characterize underweight subjects with AN. In addition to the observed relationship between PhA and body composition in individuals with AN, PhA has also been related to the basal metabolic rate (BMR). BMR undergoes changes mainly due to loss of muscle mass and a significant reduction in BMR has been observed in AN subjects. Finally, physical activity represents a significant determinant of body composition and can help regulate BMR.

Therefore, monitoring changes in body composition (LM, FM, and PhA) and indirect indices (lean mass index and fat mass index) using BIA, together with monitoring changes in BMR and physical activity level, could provide important support for the continuous control and definition of the clinical stage of the disease in patients with AN.

The aim of this study is to determine body composition, basal metabolic rate, and level of physical activity in Anorexia Nervosa and normal weight subjects to identify the most consistent parameters to define the clinical stage of the disease in subjects with AN.

02

Conditions studied

  • Anorexia Nervosa

Keywords

  • Anorexia
  • Resting energy expenditure
  • Hyperactivity
03

In context

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's enrollment of 32 is below the median of 78 across 142 observational studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

30 female adolescents with Anorexia nervosa, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), hospitalized at the Division of Auxologia, San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

30 normal weight adolescents recruited at the Mountain Sports Study Center of the Department of Medicine, University of Udine, Italy

Eligibility criteria

Adolescents with Anorexia Nervosa:

Inclusion Criteria:

  • Female sex
  • Age range: 12-18 years
  • Anorexia nervosa
  • Hospitalized at the Division of Auxologia, San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

Exclusion Criteria:

  • Absence of signed

Adolescents with normal weight:

Inclusion Criteria:

  • Female sex
  • Age range: 12-18 years
  • Normal weight

Exclusion Criteria:

  • Absence of signed informed consent
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • Anorexia Nervosa (AN)

    Female adolescents with Anorexia Nervosa

    Other: Collection of anthropometric and biochemical parameters

  • Normal weight

    Female normal weight adolescents

    Other: Collection of anthropometric and biochemical parameters

Interventions

  • OtherCollection of anthropometric and biochemical parameters

    Collection of anthropometric parameters biochemical parameters basal metabolic rate body composition questionnaires

06

What researchers measure

Primary outcomes

  1. Fat-free mass

    Fat-free mass as assessed by bioelectrical impedance

    Time frame: Baseline

  2. Fat mass

    Fat mass as assessed by bioelectrical impedance

    Time frame: Baseline

  3. Basal Metabolic Rate

    Basal Metabolic Rate as calculated

    Time frame: Baseline

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Nov 6, 2026
Primary completion
Jul 31, 2026→Jul 22, 2026 (actual)
Nov 6, 2026
Study completion
Jul 31, 2026→Jul 22, 2026 (actual)
Nov 6, 2026
Enrollment
60 (estimated)→32 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Completed
    Primary completion Jul 31, 2026→Jul 22, 2026 (now actual)
    Study completion Jul 31, 2026→Jul 22, 2026 (now actual)
    Enrollment 60 (estimated)→32 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06800742
Responsible party
Sponsor
First posted
Jan 30, 2025
Start date
Jul 12, 2024
Primary completion
Jul 22, 2026
Completion
Jul 22, 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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