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Enrolling By Invitation
NCT07494253
Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents
Conditions: Obesity
Sex: All
Ages: 6 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: University of Bari Aldo Moro
Location: Ospedale Pediatrico Giovanni XXIII Bari
Summary
The study entitled "Effects of Reducose on Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by Reducose, a food supplement extracted from white mulberry (Morus alba), after 12 weeks of treatment in a cohort of obese children and adolescents.
Clinical and anthropometric data (age, sex, weight, height, BMI, pubertal stage) will be collected, along with data from blood chemistry tests performed during routine follow-up visits, in accordance with Good Clinical Practice guidelines.
Eligibility Criteria
Inclusion Criteria:
* Body mass index (BMI) \>95° percentile for age and sex, according to WHO growth standards
* absence of chronic deseases
Exclusion Criteria:
* diagnosis of type 1 diabetes
* chronic use of steroid drugs
* known allergies or hypersensitvity to any component of the stusy product (Reducose)
* use of medications known to affect glucose metabolism
Source: ClinicalTrials.gov (NCT07494253). StuddyBuddy aggregates publicly available trial information.