Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents

Condition(s) studied

Investigational drug(s) / intervention(s)

Reducose: Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks

Placebo: Participants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients.

Study summary

The study entitled "Effects of mulberry leaf extract formulationon Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by 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

Primary outcome measure(s)

• Area Under the Curve for Plasma Glucose — Baseline and Week 12
  Calculated from plasma glucose concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
• Area under the curve (AUC) for plasma insulin — Baseline and Week 12
  Calculated from plasma insulin concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
• Maximum plasma glucose concentration (Gmax) — Baseline and Week 12
  Maximum plasma glucose concentration observed during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
• Time to maximum plasma glucose concentration (Tmax) — Baseline and Week 12
  Time required to reach the maximum plasma glucose concentration during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
• Glycated Hemoglobin — Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
  Change in glycated hemoglobin (HbA1c)
• Homeostasis Model Assessment of Insulin Resistance — Baseline to Week 12
  Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.

Trial sites (1)

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