Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
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
Pharmanutra S.p.a.
144 participants
Dec 11, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- Age ≥18 years and ≤ 65 years old;
- BMI ≥ 30 Kg/m2 and ≤45 kg/m2
- BMI from 27 kg/m2 to 30 Kg/m2 with at least one associated co-morbidity related to overweight \[e.g. dysglycemia (pre-diabetes and/or metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\], or cardiovascular disease\]
- Starting to use a GLP-1 RAs (liraglutide, semaglutide) or dual GIP and GLP-1 RAs (tirzepatide) for weight reduction; patient can be enrolled if they start the treatment at the time of enrollment or up to 2 weeks
- Diet composition adjusted to provide 0.9-1.1 g/Kg ideal body weight proteins
- Signed informed consent
Exclusion Criteria9
- Type I and Type II diabetes; patients with pre-diabetes and/or metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled
- Monogenic obesity (Subjects with a known diagnosis of monogenic obesity, including but not limited to pathogenic mutations in LEP, LEPR, MC4R, POMC, PCSK1, or other genes known to cause monogenic forms of early-onset or syndromic obesity)
- Reduced kidney function, defined as eGFR < 60 mL/min/1.73 m², calculated using the CKD-EPI equation (see Appendix 1)
- Oncologic patients in active treatments
- Hypersensitivity to any of the constituents of the study product
- Pregnancy
- Breastfeeding
- Use of meal replacements for a diet enriched with aminoacids and/or HMB
- Use of food supplements containing aminoacids and/or HMB; patients can be included in the study if they undergo a washout period of at least 15 days
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Interventions
A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.
Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07393360