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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Dietary supplement: Myosave®; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Sole Rossato; Phone Number: +390507846500; Email: ms.rossato@pharmanutra.it

Study Locations

• Italy
  • Milan, Italy, 20145
    • Recruiting
    • IRCCS Auxologico
    • Contact: Simona Bertoli, Prof.; Phone Number: +39 349 8130845; Email: simona.bertoli@unimi.it
    • Principal Investigator: Simona Bertoli, Prof.
  • Roma, Italy, 00163
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Massimiliano Caprio, Prof.; Phone Number: +39 06 52253419; Email: massimiliano.caprio@sanraffaele.it
    • Principal Investigator: Massimiliano Caprio, Prof.
  • Rozzano, Italy, 20089
    • Recruiting
    • IRCCS Istituto Clinico Humanitas
    • Contact: Roberto Vettor, Prof.; Phone Number: +39 3356108167; Email: roberto.vettor@humanitas.it
    • Principal Investigator: Roberto Vettor, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myosave®; Participants receive Myosave® twice daily (two sachets/day) for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.	Dietary supplement: Myosave®; A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.
Placebo Comparator: Placebo; Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.	Other: Placebo; Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Appendicular Skeletal Muscle Mass (ASMM)	ASMM will be assessed using Bioelectrical Impedance Vector Analysis (BIVA). The primary endpoint is the change in ASMM from baseline to Week 24 to determine whether the Food for Special Medical Purposes (FSMP) preserves skeletal muscle mass compared with placebo.	Baseline, Week 8, Week 16, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip Strength	Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function.	Baseline, Week 8, Week 16, Week 24
Change in Fat-Free Mass (FFM)	Change in Fat-Free Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output.	Baseline, Week 8, Week 16, Week 24
Change in Fat Mass (FM)	Change in Fat Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output.	Baseline, Week 8, Week 16, Week 24
Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36)	The Short Form-36 Health Survey (SF-36) assesses physical and mental health-related quality of life. The scale consists of 36 items scored into 8 domains. Each domain score ranges from 0 to 100, where higher scores indicate better health status. Domains include: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health.	Baseline, Week 8, Week 16, Week 24
Change in Body Weight (kg)	Change in body weight measured in kilograms from baseline to Week 24. Continuous variable reported according to standard clinical procedures.	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Pharmanutra S.p.a.
• Collaborators: Sintesi Research Srl

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Weight Loss; Body Composition; Muscle Mass Preservation; BIVA
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss
• Other Study ID Numbers: MYO-PRESERVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No