Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07494253

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Pediatrico Giovanni XXIII

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. Glycated Hemoglobin

    Time frame: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.

    Change in glycated hemoglobin (HbA1c)

  6. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Change in waist circumference

    Time frame: Baseline and week 12

    Change in waist circumference measured during study visits as part of anthropometric assessment

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Registry information

Official study title

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

Acronym: PEDRED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.