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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reducose | Dietary Supplement | Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change in body weight measured during study visits as part of anthropometric assessment. | Baseline, Week 4, Week 8, and Week 12 |
| Change in body mass index (BMI) | Change in body mass index, calculated from body weight and height measured during study visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Pediatrico Giovanni XXIII | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28225835 | Background | 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. | |
| 26511964 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| baseline and week 12 |
| Change in waist circumference | Change in waist circumference measured during study visits as part of anthropometric assessment | Baseline and week 12 |
| Treatment adherence | 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. | Baseline, Week 4, Week 8, and Week 12 |
| 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. |
| 29530616 | 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. |
| 27733446 | 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. |
| 27054886 | 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. |
| 35629924 | 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. |
| 31393724 | 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. |
| 8001624 | Background | Bischoff H. Pharmacology of alpha-glucosidase inhibition. Eur J Clin Invest. 1994 Aug;24 Suppl 3:3-10. |
| 36877269 | 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. |
| 26850343 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |