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Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Sponsor: Pharmanutra S.p.a.
Summary
This study evaluates whether a Food for Special Medical Purposes (FSMP) can help to preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists. Participants will receive the FSMP or a matching placebo for 24 weeks while continuing standard GLP-1-based therapy. ASMM will be measured using Bioelectrical Impedance Vector Analysis (BIVA).
Official title: Evaluating the Effect of a Food for Special Medical Purposes Containing Essential Amino Acids (EAA), Carnitine, Arginine, and Sucrosomial Minerals on the Preservation of Appendicular Skeletal Muscle Mass (ASMM) During a Weight Loss Program With GLP-1 Receptor Agonists
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-12-11
Completion Date
2026-12
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Myosave®
A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.
Placebo
Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks
Locations (3)
IRCCS Auxologico
Milan, Italy
IRCCS San Raffaele
Roma, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy