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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
144
IRCCS Auxologico
Milan, Italy
NOT_YET_RECRUITINGIRCCS San Raffaele
Roma, Italy
RECRUITINGIRCCS Istituto Clinico Humanitas
Rozzano, Italy
NOT_YET_RECRUITINGChange 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.
Time frame: Baseline, Week 8, Week 16, Week 24
Handgrip Strength
Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Baseline to Week 24