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

NCT05290285 | Recruiting

• 1 other identifier: ATAN/22
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

lean body mass; amino-acids

Outcome Measures

Primary Outcomes (1)

• Lean body mass

  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)

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

Secondary Outcomes (5)

• Physical fitness

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

• Body weight

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

• Eating disorder psychopathology

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

• General psychopathology

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

• Clinical impairment

  From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)

Study Arms (2)

EAA supplementation

EXPERIMENTAL

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).

Dietary Supplement: Amino-Ther Pro

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Amino-Ther Pro DIETARY_SUPPLEMENT

Food supplements

EAA supplementation

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of anorexia nervosa
• Age between 16 and 50 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Villa Garda Hospital: lead
• University of Milan: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (1)

Department of Eating and Weight Disorders, Villa Garda Hospital

Garda, Italy, 37016, Italy

RECRUITING

Related Publications (6)

• Dalle Grave R, Calugi S, Conti M, Doll H, Fairburn CG. Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial. Psychother Psychosom. 2013;82(6):390-8. doi: 10.1159/000350058. Epub 2013 Sep 20.

  PMID: 24060628 BACKGROUND

• El Ghoch M, Pourhassan M, Milanese C, Muller MJ, Calugi S, Bazzani PV, Dalle Grave R. Changes in lean and skeletal muscle body mass in adult females with anorexia nervosa before and after weight restoration. Clin Nutr. 2017 Feb;36(1):170-178. doi: 10.1016/j.clnu.2015.10.006. Epub 2015 Oct 28.

  PMID: 26560758 BACKGROUND

• Buondonno I, Sassi F, Carignano G, Dutto F, Ferreri C, Pili FG, Massaia M, Nisoli E, Ruocco C, Porrino P, Ravetta C, Riganti C, Isaia GC, D'Amelio P. From mitochondria to healthy aging: The role of branched-chain amino acids treatment: MATeR a randomized study. Clin Nutr. 2020 Jul;39(7):2080-2091. doi: 10.1016/j.clnu.2019.10.013. Epub 2019 Oct 18.

  PMID: 31672329 BACKGROUND

• Israely M, Ram A, Brandeis R, Alter Z, Avraham Y, Berry EM. A Double Blind, Randomized Cross-Over Trial of Tyrosine Treatment on Cognitive Function and Psychological Parameters in Severe Hospitalized Anorexia Nervosa Patients. Isr J Psychiatry. 2017;54(3):52-58.

  PMID: 29735813 BACKGROUND

• Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.

  PMID: 12711261 BACKGROUND

• Dalle Grave R, Calugi S, Ruocco C, Chimini M, Segala A, Ragni M, Carruba M, Valerio A, Nisoli E. Efficacy 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. Trials. 2023 Feb 9;24(1):104. doi: 10.1186/s13063-023-07120-7.

  PMID: 36759873 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Riccardo Dalle Grave, MD

  Villa Garda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Dalle Grave, MD

CONTACT

348 412 0680; rdalleg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind RCT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: A 13-week randomized double-blind placebo-controlled study. Patients will be randomized to EAA supplementation or placebo supplementation upon admission. Randomisation will be carried out by an independent external figure adopting the following stratification: Group 1: BMI \<= 15.2 \& age \<= 20 Group 2: BMI \> 15.2 \& age \<= 20 Group 3: BMI \<= 15.2 \& age \> 20 Group 4: BMI \> 15.2 \& age \> 20

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)