Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment

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 Criteria:

* 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 Criteria:

* 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

Conditions2

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