Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

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

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Inpatient treatment for 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 Type: Observational
• Enrollment (Actual): 154

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 - 28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88 patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.

Description

Patient 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inpatient treatment for Anorexia nervosa; Adolescents with anorexia nervosa assessed; at baseline: on admission to inpatient treatment; at follow-up: 6 months after admission on outpatient basis	Other: Inpatient treatment for Anorexia nervosa; Nutritional rehabilitation in a clinic with specialized eating disorder service
Controls; Adolescent healthy and normal weight controls (matched for gender and age), assessed at one point of time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Body protein	Change in Total Body protein	Between baseline (inpatient admission) and at 7 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of Sydney
• Investigators: Principal Investigator: Michael R Kohn, Prof., University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2004
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Body composition; nutritional recovery; Total body protein; Exercise status; In-vivo neutron activation analysis; Protein depletion
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: TBN in AN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No