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A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes

INTRODUCTION: Reducing postprandial (PP) hyperglycemia and PP glucose excursions is important for overall glycemic management. Although most therapeutic lifestyle interventions that reduce caloric intake would affect this, there is no particular nutritional intervention favored. METHODS: We evaluate...

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Autores principales: Mohamed, Mafauzy, Zagury, Roberto Luis, Bhaskaran, Kalpana, Neutel, Joel, Mohd Yusof, Barakatun Nisak, Mooney, Linda, Yeo, Lihe, Kirwan, Bridget-Anne, Aprikian, Olivier, von Eynatten, Maximilian, Johansen, Odd Erik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10064401/
https://www.ncbi.nlm.nih.gov/pubmed/36855010
http://dx.doi.org/10.1007/s13300-023-01379-4
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author Mohamed, Mafauzy
Zagury, Roberto Luis
Bhaskaran, Kalpana
Neutel, Joel
Mohd Yusof, Barakatun Nisak
Mooney, Linda
Yeo, Lihe
Kirwan, Bridget-Anne
Aprikian, Olivier
von Eynatten, Maximilian
Johansen, Odd Erik
author_facet Mohamed, Mafauzy
Zagury, Roberto Luis
Bhaskaran, Kalpana
Neutel, Joel
Mohd Yusof, Barakatun Nisak
Mooney, Linda
Yeo, Lihe
Kirwan, Bridget-Anne
Aprikian, Olivier
von Eynatten, Maximilian
Johansen, Odd Erik
author_sort Mohamed, Mafauzy
collection PubMed
description INTRODUCTION: Reducing postprandial (PP) hyperglycemia and PP glucose excursions is important for overall glycemic management. Although most therapeutic lifestyle interventions that reduce caloric intake would affect this, there is no particular nutritional intervention favored. METHODS: We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on improving PP glucometabolic response in a randomized controlled exploratory crossover, two-center study (USA, Singapore). A 2-g blend of 250 mg MLE [containing 12.5 mg of 1-deoxynojirimycin (DNJ)], fiber (1.75 g), vitamin D(3) (0.75 μg), and chromium (75 μg), compared with a similar blend without the MLE, was sprinkled over a 350-kcal breakfast meal (55.4 g carbs) and PP blood glucose (primary exploratory endpoint), insulin, and incretin hormones (GLP-1, GIP) were evaluated in blood samples over 3 h. Changes in incremental areas under the concentration curve (iAUC) and maximum concentrations (C(max)) were compared. RESULTS: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m(2)) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (− 20%, p < 0.0001), 2 h (− 17%, p = 0.0001), and 3 h (− 15%, p = 0.0032) and C(max) [mean (95% CI) difference − 0.8 (− 1.2, − 0.3) mmol/L, p = 0.0006]. A statistically significant reduction in 1 h insulin iAUC (− 24%, p = 0.0236) was observed, but this reduction was no longer present at either 2 h or 3 h. No difference in GLP-1 was seen, but GIP response (iAUC and C(max)) was less with the MLE-based blend. CONCLUSIONS: The observation of a significant glucose reduction paralleled with a significant lower insulin response supports a reduced gastrointestinal glucose absorption. These results support the use of a 2-g natural blend of MLE, fiber, vitamin D, and chromium in T2D as a convenient dietary adjuvant to improve PP glucometabolic response. ClinicalTrials.gov identifier NCT04877366. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-023-01379-4.
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spelling pubmed-100644012023-04-01 A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes Mohamed, Mafauzy Zagury, Roberto Luis Bhaskaran, Kalpana Neutel, Joel Mohd Yusof, Barakatun Nisak Mooney, Linda Yeo, Lihe Kirwan, Bridget-Anne Aprikian, Olivier von Eynatten, Maximilian Johansen, Odd Erik Diabetes Ther Original Research INTRODUCTION: Reducing postprandial (PP) hyperglycemia and PP glucose excursions is important for overall glycemic management. Although most therapeutic lifestyle interventions that reduce caloric intake would affect this, there is no particular nutritional intervention favored. METHODS: We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on improving PP glucometabolic response in a randomized controlled exploratory crossover, two-center study (USA, Singapore). A 2-g blend of 250 mg MLE [containing 12.5 mg of 1-deoxynojirimycin (DNJ)], fiber (1.75 g), vitamin D(3) (0.75 μg), and chromium (75 μg), compared with a similar blend without the MLE, was sprinkled over a 350-kcal breakfast meal (55.4 g carbs) and PP blood glucose (primary exploratory endpoint), insulin, and incretin hormones (GLP-1, GIP) were evaluated in blood samples over 3 h. Changes in incremental areas under the concentration curve (iAUC) and maximum concentrations (C(max)) were compared. RESULTS: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m(2)) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (− 20%, p < 0.0001), 2 h (− 17%, p = 0.0001), and 3 h (− 15%, p = 0.0032) and C(max) [mean (95% CI) difference − 0.8 (− 1.2, − 0.3) mmol/L, p = 0.0006]. A statistically significant reduction in 1 h insulin iAUC (− 24%, p = 0.0236) was observed, but this reduction was no longer present at either 2 h or 3 h. No difference in GLP-1 was seen, but GIP response (iAUC and C(max)) was less with the MLE-based blend. CONCLUSIONS: The observation of a significant glucose reduction paralleled with a significant lower insulin response supports a reduced gastrointestinal glucose absorption. These results support the use of a 2-g natural blend of MLE, fiber, vitamin D, and chromium in T2D as a convenient dietary adjuvant to improve PP glucometabolic response. ClinicalTrials.gov identifier NCT04877366. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-023-01379-4. Springer Healthcare 2023-03-01 2023-04 /pmc/articles/PMC10064401/ /pubmed/36855010 http://dx.doi.org/10.1007/s13300-023-01379-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Mohamed, Mafauzy
Zagury, Roberto Luis
Bhaskaran, Kalpana
Neutel, Joel
Mohd Yusof, Barakatun Nisak
Mooney, Linda
Yeo, Lihe
Kirwan, Bridget-Anne
Aprikian, Olivier
von Eynatten, Maximilian
Johansen, Odd Erik
A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title_full A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title_fullStr A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title_full_unstemmed A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title_short A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes
title_sort randomized, placebo-controlled crossover study to evaluate postprandial glucometabolic effects of mulberry leaf extract, vitamin d, chromium, and fiber in people with type 2 diabetes
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10064401/
https://www.ncbi.nlm.nih.gov/pubmed/36855010
http://dx.doi.org/10.1007/s13300-023-01379-4
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