Body Composition in Adolescents With Anorexia Nervosa

NCT ID: NCT06800742

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2026-07-31

Brief 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.

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.

Conditions

Anorexia Nervosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Anorexia Nervosa (AN)

Female adolescents with Anorexia Nervosa

Collection of anthropometric and biochemical parameters

Intervention Type: OTHER

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

Normal weight

Female normal weight adolescents

Collection of anthropometric and biochemical parameters

Intervention Type: OTHER

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

Interventions

Collection of anthropometric and biochemical parameters

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

Intervention Type: OTHER

Eligibility Criteria

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

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

Exclusion Criteria

• Absence of signed informed consent

Adolescents with normal weight:

• Absence of signed informed consent

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Sartorio, MD

Role: CONTACT

sartorio@auxologico.it

+390261911 ext. 2426

l Grappiolo, Dr.

Role: CONTACT

luca.grappiolo@auxologico.it

Facility Contacts

Alessandro Sartorio, MD

Role: primary

sartorio@auxologico.it

+39-02619111 ext. 2426

Other Identifiers

01C409

Identifier Type: -

Identifier Source: org_study_id