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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 waiting period after previous treatment of at least 15 days Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Myosave®

A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.

OTHER

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