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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: f
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• Diagnosis of anorexia nervosa

• Age between 16 and 50 years

• Written informed consent

Locations
Other Locations
Italy
Department of Eating and Weight Disorders, Villa Garda Hospital
RECRUITING
Garda
Contact Information
Primary
Riccardo Dalle Grave, MD
rdalleg@gmail.com
348 412 0680
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 92
Treatments
Experimental: EAA supplementation
The EAA blend consists of a complex blend of essential amino acids, including some precursors of neurotransmitters that are important for regulating mood. In particular, phenylalanine, a precursor of tyrosine (non-essential amino acid) is involved in the biosynthesis of catecholamines (noradrenaline, adrenaline, dopamine) and tryptophan is the precursor of serotonin. Furthermore, the amino acids present in the mixture and the precursors of the Krebs cycle (citrate, malate, succinate) are able to stimulate mitochondrial bioenergetics by improving metabolism and muscle function.~The EAA blend will be administered orally at 4.5 g twice daily (two sachets of Amino-Ther Pro per day).
Placebo_comparator: Placebo
Placebo is an isocaloric product containing maltodextrins instead of amino acids (Acquilani et al., 2011). The placebo will be administered orally 4.5 g twice daily.
Related Therapeutic Areas
Sponsors
Collaborators: University of Milan, Università degli Studi di Brescia
Leads: Villa Garda Hospital

This content was sourced from clinicaltrials.gov