Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334032
• Other study ID #: TBN in AN
• Status: Completed
• Phase: N/A
• First received: October 29, 2017
• Last updated: November 2, 2017
• Start date: July 2004
• Est. completion date: July 2010

Study information

• Verified date: November 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Inpatient treatment for Anorexia nervosa
Nutritional rehabilitation in a clinic with specialized eating disorder service

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	University of Sydney

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Body protein	Change in Total Body protein	Between baseline (inpatient admission) and at 7 months follow-up
Secondary	Change in body weight	Change in: body weight (kg)	Between baseline (inpatient admission) and at 7 months follow-up
Secondary	Change in Body Mass Index	Change in Body Mass Index (BMI; kg/m2)	Between baseline (inpatient admission) and at 7 months follow-up
Secondary	Change in body fat mass	Change in body fat mass (kg)	Between baseline (inpatient admission) and at 7 months follow-up
Secondary	Change in body lean tissue mass	Change in body lean tissue mass (kg)	Between baseline (inpatient admission) and at 7 months follow-up