Body Composition in Adolescents With Anorexia Nervosa | NCT06800742

Studies
Body Composition in Adolescents With Anorexia Nervosa

NCT06800742

Sponsor

Istituto Auxologico Italiano

Status

Recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Collection of anthropometric and biochemical parameters

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2024Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Jan 24, 2025

First Submission Date that Met QC Criteria

Jan 24, 2025

First Posted Date

Jan 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Collection of anthropometric and biochemical parameters	Other	Collection of anthropometric parameters biochemical parameters basal metabolic rate body composition questionnaires

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 informed consent

Adolescents with normal weight:

Inclusion Criteria:

Female sex
Age range: 12-18 years
Normal weight

Exclusion Criteria:

Absence of signed informed consent

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alessandro Sartorio, MD	Contact	+390261911	2426	sartorio@auxologico.it
l Grappiolo, Dr.	Contact		2894	luca.grappiolo@auxologico.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Auxologico Italiano IRCCS, Site Piancavallo	Recruiting	Oggebbio	Verbania	28824	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D000855	Anorexia
D013035	Spasm

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

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Browse Branches

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