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RECRUITING
NCT05290285
NA

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

Sponsor: Villa Garda Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2022-07-01

Completion Date

2027-01-01

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Amino-Ther Pro

Food supplements

DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Locations (1)

Department of Eating and Weight Disorders, Villa Garda Hospital

Garda, Italy, Italy