NCT07494253

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
1mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

March 12, 2026

Last Update Submit

April 8, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

  • 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).

    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).

    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.

    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.

    Baseline and Week 12

  • Glycated Hemoglobin

    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

    Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.

    Baseline to Week 12

Secondary Outcomes (4)

  • Change in body weight

    Baseline, Week 4, Week 8, and Week 12

  • Change in body mass index (BMI)

    baseline and week 12

  • Change in waist circumference

    Baseline and week 12

  • Treatment adherence

    Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

Reducose

EXPERIMENTAL

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

Dietary Supplement: Reducose

placebo

PLACEBO COMPARATOR

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

Interventions

ReducoseDIETARY_SUPPLEMENT

Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks

Reducose
PlaceboOTHER

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.

placebo

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Body mass index (BMI) \>95° percentile for age and sex, according to WHO growth standards
  • absence of chronic deseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Pediatrico Giovanni XXIII

Bari, 70124, Italy

Location

Related Publications (10)

  • Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne CD, Lewith G. Mulberry extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: results of a randomized double-blind placebo-controlled study.

    BACKGROUND

  • Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne CD, Lewith G. Mulberry extract to modulate blood glucose responses in normoglycaemic adults (MULBERRY): study protocol for a randomized controlled trial.

    BACKGROUND

  • Li Y, Zhang X, Liang C, Hu J, Yu Z. Safety evaluation of mulberry leaf extract: acute, subacute toxicity and genotoxicity studies.

    BACKGROUND

  • Marx TK, Glávits R, Endres JR, Palmer PA, Clewell AE, Murbach TS, Hirka G, Pasics I. A 28- day repeated dose toxicological study of an aqueous extract of Morus alba L.

    BACKGROUND

  • Liu Y, Li X, Xie C, Luo X, Bao Y, Wu B, Hu Y, Zhong Z, Liu C, Li M. Prevention effects and possible molecular mechanism of mulberry leaf extract and its formulation on rats with insulin-insensitivity.

    BACKGROUND

  • Hjørne AP, Modvig IM, Holst JJ. The sensory mechanisms of nutrient-induced GLP-1 secretion. Metabolites 2022, 12, 420.

    BACKGROUND

  • Hu TG, Wen P, Shen WZ, Liu F, Li Q, Li EN, et al. Effect of 1-deoxynojirimycin isolated from mulberry leaves on glucose metabolism and gut microbiota in a streptozotocin-induced diabetic mouse model. J Nat Prod 2019, 82(8), 2189-200.

    BACKGROUND

  • AG, HBB. Pharmacology of α-glucosidase inhibition. Eur J Clin Invest 1994, 24, 3-10.

    BACKGROUND

  • Batiha GE, Al-Snafi AE, Thuwaini MM, Teibo JO, Shaheen HM, Akomolafe AP, et al. Morus alba: a comprehensive phytochemical and pharmacological review. Naunyn-Schmiedeberg Arch Pharmacol 2023, 396, 1399-413.

    BACKGROUND

  • Chan EWC, Lye PY, Wong SK. Phytochemistry, pharmacology, and clinical trials of Morus alba. Chin J Nat Med 2016, 14(1), 17-30.

    BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Paediatrics

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 27, 2026

Study Start

June 1, 2025

Primary Completion

January 12, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

IT(1)