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

June 17, 2026 updated by: Maria Felicia Faienza, University of Bari Aldo Moro

Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents: A Pilot Study (PEDRED)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Ospedale Pediatrico Giovanni XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Other: 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.
Experimental: mulberry leaf extract formulation
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
Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve for Plasma Glucose
Time Frame: 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).
Baseline and Week 12
Area under the curve (AUC) for plasma insulin
Time Frame: 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).
Baseline and Week 12
Maximum plasma glucose concentration (Gmax)
Time Frame: 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.
Baseline and Week 12
Time to maximum plasma glucose concentration (Tmax)
Time Frame: 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.
Baseline and Week 12
Glycated Hemoglobin
Time Frame: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Change in glycated hemoglobin (HbA1c)
Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Homeostasis Model Assessment of Insulin Resistance
Time Frame: Baseline to Week 12
Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline, Week 4, Week 8, and Week 12
Change in body weight measured during study visits as part of anthropometric assessment.
Baseline, Week 4, Week 8, and Week 12
Change in body mass index (BMI)
Time Frame: baseline and week 12
Change in body mass index, calculated from body weight and height measured during study visits
baseline and week 12
Change in waist circumference
Time Frame: Baseline and week 12
Change in waist circumference measured during study visits as part of anthropometric assessment
Baseline and week 12
Treatment adherence
Time Frame: 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.
Baseline, Week 4, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari Aldo Moro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

January 12, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2078/CEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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