Study of Essential Amino Acid Supplementation to Improve Lean Body Mass in Patients With Anorexia Nervosa During Hospital Treatment
Led by Villa Garda Hospital · Updated on 2025-09-05
92
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying anorexia nervosa AN, a condition that causes severe weight loss and health problems. This research aims to see if a specific blend of essential amino acids EAA can help increase lean body mass in patients with AN while they undergo weight restoration treatment. The study also looks at changes in body weight, physical fitness, and psychological health over 13 weeks, comparing EAA supplementation to a placebo.
Participants will be randomly assigned to receive either the EAA blend or a placebo during a 13-week inpatient or day hospital treatment. The EAA supplement is given orally twice daily at a dose of 4.5 grams. Both groups will receive intensive enhanced cognitive behavior therapy CBT-E aimed at weight recovery and managing eating disorder symptoms. After the initial 13 weeks, participants may continue EAA treatment for an additional 24 weeks to assess longer-term effects.
During the study, patients will have medical evaluations, physical exams, and questionnaires to assess body composition, eating disorder symptoms, general psychological health, and physical fitness. Lean body mass will be measured at the start and end of hospitalization. Researchers will monitor progress weekly, and follow-up assessments will occur after 24 weeks. The entire participation period includes inpatient treatment and possible extended supplementation, lasting up to 37 weeks in total.
CONDITIONS
Brief Title
Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo
Research Team
R
Riccardo Dalle Grave, MD
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Being pregnant or planning pregnancy during treatment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 13 weeks
Participants receive either essential amino acid supplementation or placebo along with enhanced cognitive behavior therapy (CBT-E) during a 13-week inpatient or day hospital program aimed at weight recovery and remission from anorexia nervosa.
Weekly visits for supervision and treatment assessment
Follow-up
Duration - 24 weeks
Participants are followed for 24 weeks after treatment to evaluate long-term maintenance of treatment effects. Participants who received essential amino acids may continue supplementation during this period.
Periodic visits during follow-up
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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Published Research Related To This Trial
Efficacy and tolerability of a specific blend of amino acids in patients with anorexia nervosa treated in a hospital setting: study protocol for a randomized controlled trial.
Riccardo Dalle Grave, Simona Calugi, Chiara Ruocco...
A Double Blind, Randomized Cross-Over Trial of Tyrosine Treatment on Cognitive Function and Psychological Parameters in Severe Hospitalized Anorexia Nervosa Patients.