Clinical trial NCT03334032: Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
Official title: Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Body composition
Total body protein
nutritional recovery
Exercise status
In-vivo neutron activation analysis
Protein depletion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2017-11-07
Enrollment: 154
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Body protein
timeFrame: Between baseline (inpatient admission) and at 7 months follow-up
Secondary outcomes:
measure: Change in body weight
timeFrame: Between baseline (inpatient admission) and at 7 months follow-up
measure: Change in Body Mass Index
timeFrame: Between baseline (inpatient admission) and at 7 months follow-up
measure: Change in body fat mass
timeFrame: Between baseline (inpatient admission) and at 7 months follow-up
measure: Change in body lean tissue mass
timeFrame: Between baseline (inpatient admission) and at 7 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: University of Sydney
name: Michael R Kohn, Prof.
role: PRINCIPAL_INVESTIGATOR
References: