Actively Recruiting
Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo
Led by Villa Garda Hospital · Updated on 2025-09-05
92
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
V
Villa Garda Hospital
Lead Sponsor
U
University of Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of anorexia nervosa
- Age between 16 and 50 years
- Written informed consent
You will not qualify if you...
- Schizophrenia or other psychotic disorders
- Diagnosis of bulimia nervosa
- Current and ongoing substance use disorder
- Medical complications that could affect result interpretation, such as diseases causing weight loss
- Physical treatments, including drugs, that could affect result interpretation, such as chemotherapy for cancer
- Being pregnant or intending to become pregnant during treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Eating and Weight Disorders, Villa Garda Hospital
Garda, Italy, Italy, 37016
Actively Recruiting
Research Team
R
Riccardo Dalle Grave, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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