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 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 (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 (- 20%, p 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 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.