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

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

Overview

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).

Detailed description

This randomized, double-blind, placebo-controlled investigates whether a Food for Special Medical Purposes (FSMP) can help preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists.

Eligible participants are adults with obesity or overweight with comorbidities who are initiating GLP-1-based therapy as part of standard clinical management. Participants are randomized in a 1:1 ratio to receive either the FSMP or a matching placebo for 24 weeks, in addition to their ongoing GLP-1 RA or dual GIP/GLP-1 RA therapy. Study visits occur at baseline, 8 weeks, 16 weeks, and 24 weeks.

This trial aims to determine whether targeted nutritional support can mitigate the loss of lean mass commonly observed during pharmacologically assisted weight loss, thereby improving functional outcomes and overall patient well-being.

Interventions

• 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

Primary outcome measures

• Change in Appendicular Skeletal Muscle Mass (ASMM) [Time frame: Baseline, Week 8, Week 16, Week 24]

Secondary outcome measures (5)

• Handgrip Strength [Time frame: Baseline, Week 8, Week 16, Week 24]
• Change in Fat-Free Mass (FFM) [Time frame: Baseline, Week 8, Week 16, Week 24]
• Change in Fat Mass (FM) [Time frame: Baseline, Week 8, Week 16, Week 24]
• Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36) [Time frame: Baseline, Week 8, Week 16, Week 24]
• Change in Body Weight (kg) [Time frame: Baseline to Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Supportive care

Study locations

Italy · 3 centers

• IRCCS Auxologico — Milan
• IRCCS San Raffaele — Roma
• IRCCS Istituto Clinico Humanitas — Rozzano

Identifiers

NCT: NCT07393360 · MYO-PRESERVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗