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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
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Springer Healthcare
2023
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| Online Access: | http://psasir.upm.edu.my/id/eprint/106660/ |
| _version_ | 1848864799773949952 |
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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 |
| building | UPM Institutional Repository |
| collection | Online Access |
| 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 D3 (0.75 ¼g), and chromium (75 ¼g), 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 (Cmax) were compared. Results: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m2) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (ˆ’ 20%, p < 0.0001), 2 h (ˆ’ 17%, p = 0.0001), and 3 h (ˆ’ 15%, p = 0.0032) and Cmax mean (95% CI) difference ˆ’ 0.8 (ˆ’ 1.2, ˆ’ 0.3) mmol/L, p = 0.0006. A statistically significant reduction in 1 h insulin iAUC (ˆ’ 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 Cmax) 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. |
| first_indexed | 2025-11-15T13:54:33Z |
| format | Article |
| id | upm-106660 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-15T13:54:33Z |
| publishDate | 2023 |
| publisher | Springer Healthcare |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-1066602024-09-26T08:25:40Z http://psasir.upm.edu.my/id/eprint/106660/ 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 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 D3 (0.75 ¼g), and chromium (75 ¼g), 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 (Cmax) were compared. Results: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m2) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (ˆ’ 20%, p < 0.0001), 2 h (ˆ’ 17%, p = 0.0001), and 3 h (ˆ’ 15%, p = 0.0032) and Cmax mean (95% CI) difference ˆ’ 0.8 (ˆ’ 1.2, ˆ’ 0.3) mmol/L, p = 0.0006. A statistically significant reduction in 1 h insulin iAUC (ˆ’ 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 Cmax) 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. Springer Healthcare 2023-03-01 Article PeerReviewed Mohamed, Mafauzy and Zagury, Roberto Luis and Bhaskaran, Kalpana and Neutel, Joel and Mohd Yusof, Barakatun Nisak and Mooney, Linda and Yeo, Lihe and Kirwan, Bridget-Anne and Aprikian, Olivier and von Eynatten, Maximilian and Johansen, Odd Erik (2023) 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. Diabetes Therapy, 14 (4). pp. 749-766. ISSN 1869-6953; ESSN: 1869-6961 https://link.springer.com/article/10.1007/s13300-023-01379-4 10.1007/s13300-023-01379-4 |
| spellingShingle | 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 |
| url | http://psasir.upm.edu.my/id/eprint/106660/ http://psasir.upm.edu.my/id/eprint/106660/ http://psasir.upm.edu.my/id/eprint/106660/ |