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Lo studio clinico NCT07393360 (MYO-PRESERVE) per Obesity & Overweight è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Effetto di un alimento a fini medici speciali sulla preservazione della massa muscolare durante il trattamento per la perdita di peso con GLP-1 RA (MYO-PRESERVE) 144
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La sperimentazione clinica NCT07393360 (MYO-PRESERVE) è uno studio interventistico per Obesity & Overweight, attualmente in arruolamento. Avviato il 11 dicembre 2025, prevede di arruolare 144 partecipanti. Sotto la guida di Pharmanutra S.p.a., dovrebbe concludersi entro il 1 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 23 marzo 2026.
Sommario breve
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 A...Mostra di più
Descrizione dettagliata
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...
Mostra di piùTitolo ufficiale
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
Patologie
Obesity & OverweightAltri ID dello studio
- MYO-PRESERVE
Numero NCT
Data di inizio (effettiva)
2025-12-11
Ultimo aggiornamento pubblicato
2026-03-23
Data di completamento (stimata)
2026-12
Arruolamento (previsto)
144
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Weight Loss
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleMyosave® 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. | Myosave® A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks. |
Comparatore placeboPlacebo Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy. | PLACEBO Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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
- 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
Pharmanutra S.p.a.Sintesi Research SrlContatti principali dello studio
Contatto: Maria Sole Rossato, +390507846500, [email protected]
3 Centri dello studio in 1 paesi
IRCCS Auxologico, Milan, 20145, Italy
Simona Bertoli, Prof., Contatto, +39 349 8130845, [email protected]
Simona Bertoli, Prof., Investigatore principale
In arruolamento
IRCCS San Raffaele, Roma, 00163, Italy
Massimiliano Caprio, Prof., Contatto, +39 06 52253419, [email protected]
Massimiliano Caprio, Prof., Investigatore principale
In arruolamento
IRCCS Istituto Clinico Humanitas, Rozzano, 20089, Italy
Roberto Vettor, Prof., Contatto, +39 3356108167, [email protected]
Roberto Vettor, Prof., Investigatore principale
In arruolamento