Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Obesity & Overweight
In brief
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).
Key facts
- Study ID
- NCT07393360
- Run by
- Pharmanutra S.p.a.
- People needed
- 144
- Starts
- 2025-12-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- IRCCS Auxologico — Milan, Italy (enrolling)
- IRCCS San Raffaele — Roma, Italy (enrolling)
- IRCCS Istituto Clinico Humanitas — Rozzano, Italy (enrolling)
Full record on ClinicalTrials.gov
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