NCT05938205: MAYBE

Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE

Completed NA Last updated 10 July 2023

What this trial tests

NA trial testing AA-1 in Sarcopenic Obesity in 111 participants. Completed in 6 July 2022.

Timeline

1 March 2019

Primary endpoint
6 July 2022

6 July 2022

Quick facts

Lead sponsor	Azienda Ospedaliera Universitaria Integrata Verona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	111
Start date	1 March 2019
Primary completion	6 July 2022
Estimated completion	6 July 2022
Sites	1 location across Italy

Drugs / interventions tested

• AA-1
• AA-2
• Placebo
• Exe-H

Conditions studied

• Sarcopenic Obesity — all drugs for Sarcopenic Obesity →
• Frailty — all drugs for Frailty →
• Malnutrition; Protein — all drugs for Malnutrition; Protein →

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona — full company profile →

Who can join

Adults 60 to 80, any sex, with Sarcopenic Obesity or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be conducted in a group of obese sarcopenic patients (Sarco-Ob) aged \> 60 years on moderately hypocaloric diet therapy aimed at comparing the effect of a strength exercise protocol, combined or not with dietary supplementation with amino acids, on physical performance, muscle strength, body composition, muscle oxidative metabolism, and biomarkers of sarcopenia. The supplementation study will be conducted in a double-blind manner.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of a Hypocaloric Diet Plus Resistance Training with and Without Amino Acids in Older Participants with Dynapenic Obesity: A Randomized Clinical Trial.
   Muollo V, Rossi AP, Milanese C, Cavedon V, et al · · 2025 · cited 2× · PMID 39940276 · DOI 10.3390/nu17030418