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Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo

NCT05290285 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-09-05

No results posted yet for this study

Summary

Amino acids (AAs) are crucial for protein synthesis, in influencing nutritional status, as sources of vital elements (e.g., nucleotides, neurotransmitters) and as signal molecules for the modulation of gene expression and epigenetic mechanisms. Data on the role of amino acids in underweight patients with anorexia nervosa (AN) are unknown. This study aims to evaluate whether a blend of essential amino acids (EAA) could influence the change in lean body mass (LBM) in patients with AN during weight restoration, treated with intensive inpatient enhanced cognitive behavior therapy (CBT-E). A total of 92 patients will be randomized to EAA supplementation or placebo supplementation upon admission to inpatient treatment. LBM, but also body weight, specific and general psychopathology, impairment assessment will be assessed at baseline and after 13 weeks of treatment.

Conditions

  • Anorexia Nervosa

Interventions

DIETARY_SUPPLEMENT

Amino-Ther Pro

Food supplements

DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Università degli Studi di Brescia

    collaborator OTHER

  • Villa Garda Hospital

    lead OTHER

Principal Investigators

  • Riccardo Dalle Grave, MD · Villa Garda Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-01-01
Completion
2027-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05290285 on ClinicalTrials.gov