Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07393360
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 \[e.g. dysglycemia (pre-diabetes and/or metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\], 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07393360
Study Brief:
Protocol Section:
NCT07393360