Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT07494253

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 16 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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

Treatments and study arms

Reducose

Dietary Supplement

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

Placebo

Other

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.

Primary outcomes

Area Under the Curve for Plasma GlucoseBaseline 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 insulinBaseline 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 HemoglobinChange in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.

Change in glycated hemoglobin (HbA1c)

Homeostasis Model Assessment of Insulin ResistanceBaseline to Week 12

Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ospedale Pediatrico Giovanni XXIII🇮🇹 Bari, Italy

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