Effects of Reducose on Postprandial Glycemic Levels in Obese Children and Adolescents (PEDRED)

University of Bari Aldo Moro

Status: Invitation-only

Conditions: Obesity

Treatments: Dietary Supplement: Reducose; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07494253

2078/CEL

Details and patient eligibility

About

The study entitled "Effects of Reducose on Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by Reducose, 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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Reducose

Experimental group

Description:

Participants will receive 2 sticks of Reducose 250 mg per day, 1 at lunch and 1 at dinner, for 12 weeks.

Treatment:

Dietary Supplement: Reducose

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo