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OpenTrials
Completed

NCT Number: NCT03334032

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

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year–19 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inpatient treatment for Anorexia nervosa

Other

Nutritional rehabilitation in a clinic with specialized eating disorder service

Primary outcomes

  1. Change in Total Body protein

    Time frame: Between baseline (inpatient admission) and at 7 months follow-up

    Change in Total Body protein

Secondary outcomes

  1. Change in body weight

    Time frame: Between baseline (inpatient admission) and at 7 months follow-up

    Change in: body weight (kg)

  2. Change in Body Mass Index

    Time frame: Between baseline (inpatient admission) and at 7 months follow-up

    Change in Body Mass Index (BMI; kg/m2)

  3. Change in body fat mass

    Time frame: Between baseline (inpatient admission) and at 7 months follow-up

    Change in body fat mass (kg)

  4. Change in body lean tissue mass

    Time frame: Between baseline (inpatient admission) and at 7 months follow-up

    Change in body lean tissue mass (kg)

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • University of Sydney

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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