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NCT Number: NCT06800742

Body Composition 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.

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location status: Recruiting

Location contact

Alessandro Sartorio, MD

CONTACT

[email protected]

+39-02619111 ext. 2426

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of anthropometric and biochemical parameters

Other

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

Primary outcomes

  1. Fat-free mass

    Time frame: Baseline

    Fat-free mass as assessed by bioelectrical impedance

  2. Fat mass

    Time frame: Baseline

    Fat mass as assessed by bioelectrical impedance

  3. Basal Metabolic Rate

    Time frame: Baseline

    Basal Metabolic Rate as calculated

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Sartorio, MD

CONTACT

[email protected]

+390261911 ext. 2426

l Grappiolo, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: COCOMETANNER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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