An interventional study of Reducose and Placebo in Obesity, sponsored by University of Bari Aldo Moro. Enrolling by invitation at 1 site in Italy. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Supportive care
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Bari Aldo Moro is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 2 sticks of mulberry leaf extract formulation 250 mg per day, 1 at lunch and 1 at dinner, for 12 weeks.
Dietary Supplement: Reducose
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
Other: Placebo
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.
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
Plan to share: Undecided
Ran from Jun 2025 to primary completion in Jan 2026, 7 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 7 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Bari Aldo Moro