Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Recruiting
N/A
Interventional Study
Obesity & Overweight
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 144 (estimated)
- Sponsor
- Pharmanutra S.p.a. · Industry
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About This Trial
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 Bioelectrica…
Trial Locations
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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 syn…
Contacts