Body Composition in Adolescents With Anorexia Nervosa

NCT06800742 | Recruiting

• 1 other identifier: 01C409
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia; Resting energy expenditure; Hyperactivity

Outcome Measures

Primary Outcomes (3)

• Fat-free mass

  Fat-free mass as assessed by bioelectrical impedance

  Baseline

• Fat mass

  Fat mass as assessed by bioelectrical impedance

  Baseline

• Basal Metabolic Rate

  Basal Metabolic Rate as calculated

  Baseline

Study Arms (2)

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

Collection of anthropometric and biochemical parameters OTHER

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

Anorexia Nervosa (AN); Normal weight

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Absence of signed informed consent
• Adolescents with normal weight:
• Female sex
• Age range: 12-18 years
• Normal weight
• Absence of signed informed consent

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia; Spasm

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

+390261911; sartorio@auxologico.it

l Grappiolo, Dr.

CONTACT

luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: July 12, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)