Actively Recruiting
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Led by Pharmanutra S.p.a. · Updated on 2026-03-23
144
Participants Needed
3
Research Sites
50 weeks
Total Duration
On this page
Sponsors
P
Pharmanutra S.p.a.
Lead Sponsor
S
Sintesi Research Srl
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and up to 65 years old
- Body mass index (BMI) 30 to 45 kg/m2
- BMI 27 to 30 kg/m2 with at least one related health condition such as pre-diabetes, hypertension, dyslipidemia, sleep apnea, or cardiovascular disease
- Starting GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists for weight loss within 2 weeks before enrollment
- Diet adjusted to provide 0.9-1.1 g/kg ideal body weight of protein
- Signed informed consent
You will not qualify if you...
- Diagnosed with type 1 or type 2 diabetes
- Known monogenic obesity
- Reduced kidney function (eGFR less than 60 mL/min/1.73 m2)
- Currently receiving active cancer treatments
- Allergic to any ingredients of the study product
- Pregnant or breastfeeding
- Using meal replacements with amino acids or HMB
- Using supplements containing amino acids or HMB without a 15-day washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
IRCCS Auxologico
Milan, Italy, 20145
Actively Recruiting
2
IRCCS San Raffaele
Roma, Italy, 00163
Actively Recruiting
3
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
Research Team
M
Maria Sole Rossato
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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