Amino acid supplement to help rebuild lean body mass in anorexia nervosa
Official title: Efficacy and Tolerability of a Specific Blend of Amino Acids in Patients With Anorexia Nervosa Treated in a Hospital Setting. Double-blind Randomized Study Versus Placebo
Run by Villa Garda Hospital · NCT05290285 · Data updated 2026-11-12
This trial tests whether a daily blend of essential amino acids helps people aged 16–50 with anorexia nervosa regain lean body mass during 13 weeks of inpatient weight-restoration treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 50 Years |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Villa Garda Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Garda, Italy) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | September 5, 2025 |
| Trial ID | NCT05290285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 16–50 with a confirmed diagnosis of anorexia nervosa who are admitted for inpatient weight‑restoration treatment and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with bulimia nervosa, current psychotic disorders, active substance use disorders, pregnancy or planned pregnancy, significant medical conditions causing weight loss, or concurrent treatments that interfere with results (e.g., chemotherapy) are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blind, randomized trial in which 92 patients admitted for inpatient enhanced cognitive behavioral therapy will receive either an essential amino acid (EAA) supplement or a placebo. Supplements start on admission and participants are followed for 13 weeks with measurements at baseline and week 13. The primary outcome is change in lean body mass during weight recovery; secondary outcomes include body weight, physical fitness, eating‑disorder and general psychopathology, and functional impairment. The intervention compares Amino-Ther Pro versus placebo alongside standard specialist care.
Why it matters
Potential benefit: If successful, EAA supplementation could speed restoration of lean body mass and improve physical recovery during weight restoration.
How similar studies have gone: Evidence is limited: one prior study of L‑tyrosine reported cognitive and mood benefits, but no prior trials have tested an essential amino acid blend for lean mass recovery in anorexia nervosa.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of anorexia nervosa * Age between 16 and 50 years * Written informed consent Exclusion Criteria: * Schizophrenia or other psychotic disorders * Diagnosis of bulimia nervosa * Current and ongoing substance use disorder * Medical complications capable of hindering the interpretation of the results (e.g. a a medical disease that induces weight loss) * Presence of physical treatments (including drugs) hindering the interpretation of the results (e.g. chemotherapy for cancer) * Being pregnant or intending to become pregnant during treatment
Where it's running
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Department of Eating and Weight Disorders, Villa Garda Hospital
Garda, Italy, Italy Recruiting
Study contacts
- Principal investigator: Riccardo Dalle Grave, MD — Villa Garda Hospital
- Study coordinator: Riccardo Dalle Grave, MD
- Email: rdalleg@gmail.com
- Phone: 348 412 0680
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.