Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial.
Riccardo Dalle Grave, Simona Calugi, Maddalena Conti...
https://pubmed.ncbi.nlm.nih.gov/24060628Actively Recruiting
Phase Not Applicable
Age: 16Years - 50Years
All Genders
ID05290285
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
Led by Villa Garda Hospital · Updated on 2025-09-05
92
Participants Needed
1
Research Sites
52 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
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
Who Can Participate
Age: 16Years - 50Years
All Genders
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 interfere with results (e.g., disease causing weight loss)
- Physical treatments hindering results (e.g., chemotherapy)
- Being pregnant or planning pregnancy during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Department of Eating and Weight Disorders, Villa Garda Hospital
Garda, Italy, Italy, 37016
Actively Recruiting
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Research Team
R
Riccardo Dalle Grave, MD
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
Changes in lean and skeletal muscle body mass in adult females with anorexia nervosa before and after weight restoration.
Marwan El Ghoch, Maryam Pourhassan, Chiara Milanese...
https://pubmed.ncbi.nlm.nih.gov/26560758From mitochondria to healthy aging: The role of branched-chain amino acids treatment: MATeR a randomized study.
Ilaria Buondonno, Francesca Sassi, Giulia Carignano...
https://pubmed.ncbi.nlm.nih.gov/31672329A Double Blind, Randomized Cross-Over Trial of Tyrosine Treatment on Cognitive Function and Psychological Parameters in Severe Hospitalized Anorexia Nervosa Patients.
Mor Israely, Anca Ram, Rachel Brandeis...
https://pubmed.ncbi.nlm.nih.gov/29735813Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment.
Christopher G Fairburn, Zafra Cooper, Roz Shafran
https://pubmed.ncbi.nlm.nih.gov/12711261Efficacy 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...
https://pubmed.ncbi.nlm.nih.gov/36759873