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

Condition(s) studied

Investigational drug(s) / intervention(s)

Amino-Ther Pro: Food supplements

Placebo: Maltodextrin

Study 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.

Eligibility

Primary outcome measure(s)

• Lean body mass — From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)
  Percentage change in patient's lean body mass with weight gain at the end of hospital treatment, measured using the DXA (Prodigy Primo Lunar, A223040501, General Electric Company, Madison. WI 53707-7550, USA-EnCORE TM 2009 (v13.31) software)

Trial sites (1)

Other trials for the same condition