Body Composition in Adolescents With Anorexia Nervosa (COCOMETANNER)

November 5, 2026 updated by: Istituto Auxologico Italiano

Body Composition, Resting Energy Expenditure and Physical Activity in Adolescents With Anorexia Nervosa

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verbania
      • Oggebbio, Verbania, Italy, 28824
        • Istituto Auxologico Italiano IRCCS, Site Piancavallo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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 informed consent

Adolescents with normal weight:

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Anorexia Nervosa (AN)

Female adolescents with Anorexia Nervosa
Other: Collection of anthropometric and biochemical parameters

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

Female normal weight adolescents
Other: Collection of anthropometric and biochemical parameters

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: Baseline

Fat mass as assessed by bioelectrical impedance
Baseline
Fat-free mass
Time Frame: Baseline

Fat-free mass as assessed by bioelectrical impedance
Baseline
Basal Metabolic Rate
Time Frame: Baseline

Basal Metabolic Rate as calculated
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01C409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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