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.
At baseline (Time 0), participants undergo a comprehensive evaluation including medical history, physical examination, and anthropometric measurements. Blood tests are performed to assess liver enzymes, lipid profile, and glycated hemoglobin. Glucose metabolism is evaluated through an oral glucose tolerance test (OGTT) with repeated measurements of glucose, insulin, and C-peptide. Dietary habits and adherence to the Mediterranean diet are assessed using validated questionnaires, along with a 3-day food record. Gastrointestinal side effects and treatment adherence are also evaluated using standardized questionnaires. Follow-up visits are scheduled at 4 weeks (T1) and 8 weeks (T2). At both time points, participants receive a physical examination and anthropometric assessment, and their dietary records, gastrointestinal symptoms, and treatment adherence are reviewed. At 12 weeks (T3), a final evaluation is performed, including physical and anthropometric measurements, repeat blood tests, and a second OGTT. Dietary intake, gastrointestinal tolerability, and treatment adherence are reassessed to evaluate changes over the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks
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.
Ospedale Pediatrico Giovanni XXIII
Bari, Italy
Area Under the Curve for Plasma Glucose
Calculated from plasma glucose concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Time frame: Baseline and Week 12
Area under the curve (AUC) for plasma insulin
Calculated from plasma insulin concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Time frame: Baseline and Week 12
Maximum plasma glucose concentration (Gmax)
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 frame: Baseline and Week 12
Time to maximum plasma glucose concentration (Tmax)
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.
Time frame: Baseline and Week 12
Glycated Hemoglobin
Change in glycated hemoglobin (HbA1c)
Time frame: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Homeostasis Model Assessment of Insulin Resistance
Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.
Time frame: Baseline to Week 12
Change in body weight
Change in body weight measured during study visits as part of anthropometric assessment.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in body mass index (BMI)
Change in body mass index, calculated from body weight and height measured during study visits
Time frame: baseline and week 12
Change in waist circumference
Change in waist circumference measured during study visits as part of anthropometric assessment
Time frame: Baseline and week 12
Treatment adherence
Treatment adherence assessed using the 5-item Medication Adherence Report Scale (MARS-5). The score ranges from a minimum of 5 to a maximum of 25, where 25 indicates maximum adherence.
Time frame: Baseline, Week 4, Week 8, and Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.