Obesity
Conditions
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTReducose
Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks
OTHERPlacebo
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.
Sponsors
University of Bari Aldo Moro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, Week 4, Week 8, and Week 12 | Change in body weight measured during study visits as part of anthropometric assessment. |
| Change in body mass index (BMI) | baseline and week 12 | Change in body mass index, calculated from body weight and height measured during study visits |
| Change in waist circumference | Baseline and week 12 | Change in waist circumference measured during study visits as part of anthropometric assessment |
| Treatment adherence | Baseline, Week 4, Week 8, and Week 12 | 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. |
Countries
Italy
Outcome results
None listed