Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

Completed

• Conditions: Anorexia Nervosa
• Interventions: Other: Inpatient treatment for Anorexia nervosa

• Registration Number: NCT03334032
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa

Detailed Description

Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.

Objective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.

Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2017-10-29
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• diagnosis of anorexia nervosa (DSM-IV)
• aged 12 - 19 years
• female gender

Patient

Exclusion Criteria

• existence of a further disease with effect on body composition

Controls:

• no known disease
• normal weight

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inpatient treatment for Anorexia nervosa	Inpatient treatment for Anorexia nervosa	Adolescents with anorexia nervosa assessed 1. at baseline: on admission to inpatient treatment 2. at follow-up: 6 months after admission on outpatient basis

Primary Outcome Measures

Name	Time	Method
Change in Total Body protein	Between baseline (inpatient admission) and at 7 months follow-up	Change in Total Body protein

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Between baseline (inpatient admission) and at 7 months follow-up	Change in: body weight (kg)
Change in Body Mass Index	Between baseline (inpatient admission) and at 7 months follow-up	Change in Body Mass Index (BMI; kg/m2)
Change in body fat mass	Between baseline (inpatient admission) and at 7 months follow-up	Change in body fat mass (kg)
Change in body lean tissue mass	Between baseline (inpatient admission) and at 7 months follow-up	Change in body lean tissue mass (kg)