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

NCT07494253 | Enrolling By Invitation

• 1 other identifier: 2078/CEL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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)

mulberry leaf extract formulation

EXPERIMENTAL

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

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

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.

placebo

Reducose DIETARY_SUPPLEMENT

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

mulberry leaf extract formulation

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

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 C, Lewith G. Mulberry-extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: Results of a randomised double-blind placebo-controlled study. PLoS One. 2017 Feb 22;12(2):e0172239. doi: 10.1371/journal.pone.0172239. eCollection 2017.

  PMID: 28225835 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 randomised controlled trial. Trials. 2015 Oct 28;16:486. doi: 10.1186/s13063-015-0997-2.

  PMID: 26511964 BACKGROUND

• Li Y, Zhang X, Liang C, Hu J, Yu Z. Safety evaluation of mulberry leaf extract: Acute, subacute toxicity and genotoxicity studies. Regul Toxicol Pharmacol. 2018 Jun;95:220-226. doi: 10.1016/j.yrtph.2018.03.007. Epub 2018 Mar 9.

  PMID: 29530616 BACKGROUND

• Marx TK, Glavits 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. Int J Toxicol. 2016 Nov;35(6):683-691. doi: 10.1177/1091581816670597. Epub 2016 Oct 12.

  PMID: 27733446 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. PLoS One. 2016 Apr 7;11(4):e0152728. doi: 10.1371/journal.pone.0152728. eCollection 2016.

  PMID: 27054886 BACKGROUND

• Hjorne AP, Modvig IM, Holst JJ. The Sensory Mechanisms of Nutrient-Induced GLP-1 Secretion. Metabolites. 2022 May 7;12(5):420. doi: 10.3390/metabo12050420.

  PMID: 35629924 BACKGROUND

• Hu TG, Wen P, Shen WZ, Liu F, Li Q, Li EN, Liao ST, Wu H, Zou YX. 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 Aug 23;82(8):2189-2200. doi: 10.1021/acs.jnatprod.9b00205. Epub 2019 Aug 8.

  PMID: 31393724 BACKGROUND

• Bischoff H. Pharmacology of alpha-glucosidase inhibition. Eur J Clin Invest. 1994 Aug;24 Suppl 3:3-10.

  PMID: 8001624 BACKGROUND

• Batiha GE, Al-Snafi AE, Thuwaini MM, Teibo JO, Shaheen HM, Akomolafe AP, Teibo TKA, Al-Kuraishy HM, Al-Garbeeb AI, Alexiou A, Papadakis M. Morus alba: a comprehensive phytochemical and pharmacological review. Naunyn Schmiedebergs Arch Pharmacol. 2023 Jul;396(7):1399-1413. doi: 10.1007/s00210-023-02434-4. Epub 2023 Mar 6.

  PMID: 36877269 BACKGROUND

• Chan EW, Lye PY, Wong SK. Phytochemistry, pharmacology, and clinical trials of Morus alba. Chin J Nat Med. 2016 Jan;14(1):17-30. doi: 10.3724/SP.J.1009.2016.00017.

  PMID: 26850343 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological 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: June 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

IT (1)