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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Reducose
  Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks
• Другое 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.

Первичные конечные точки

• Area Under the Curve for Plasma Glucose [Срок оценки: Baseline and Week 12]
• Area under the curve (AUC) for plasma insulin [Срок оценки: Baseline and Week 12]
• Maximum plasma glucose concentration (Gmax) [Срок оценки: Baseline and Week 12]
• Time to maximum plasma glucose concentration (Tmax) [Срок оценки: Baseline and Week 12]
• Glycated Hemoglobin [Срок оценки: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.]
• Homeostasis Model Assessment of Insulin Resistance [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (4)

• Change in body weight [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in body mass index (BMI) [Срок оценки: baseline and week 12]
• Change in waist circumference [Срок оценки: Baseline and week 12]
• Treatment adherence [Срок оценки: Baseline, Week 4, Week 8, and Week 12]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Ospedale Pediatrico Giovanni XXIII — Bari

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Bischoff H. Pharmacology of alpha-glucosidase inhibition. Eur J Clin Invest. 1994 Aug;24 Suppl 3:3-10. PMID 8001624

Идентификаторы

NCT: NCT07494253 · 2078/CEL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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