• Ruihua Wang, Yanfen Li, Wei Mu, Ziqiang Li, Jinxia Sun, Baohe Wang, Zhong Zhong, Xiuzhen Luo, Chen Xie, and Yuhong Huang.
• Medical institution conducting clinical trials for human used drug, The 2nd Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Botanic Century (Beijing) Co, Ltd Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
• Medicine (Baltimore). 2018 Aug 1; 97 (34): e11996e11996.

Background1-Deoxynojirimycin (DNJ), a component of mulberry leaf extract (MLE), reduces postprandial hyperglycemia by inhibiting intestinal a-glycosidase. The aim of this exploratory study was to investigate the effects of MLE on the glycemic indexes (GI) of common dietary carbohydrates.MethodsThis single-center, randomized, open-label, 7-cycle self-controlled crossover study enrolled 15 healthy volunteers at the National Drug Clinical Trial Institution, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (June 2014 to December 2014). The participants were randomized to receive glucose (3 occasions), glucose+MLE, sucrose+MLE, maltose+MLE, and maltodextrin+MLE orally during 7 visits (every 3 days). Blood glucose level was tested at 15 minutes before and at 15, 30, 45, 60, 90, and 120 minutes after carbohydrate intake. The GI of each carbohydrate relative to glucose (GI = 100) was calculated using the incremental area under the curve method. Safety was assessed at each visit.ResultsAll participants completed the protocol. After carbohydrate ingestion, blood glucose level peaked at 30 minutes (glucose, glucose+MLE, sucrose+MLE, and maltose+MLE) or 45 minutes (maltodextrin+MLE) before returning to preprandial levels at 120 minutes. At 30 minutes, the change in blood glucose level was lower for sucrose+MLE, maltose+MLE, and maltodextrin+MLE than for glucose or glucose+MLE (P < .05). GI was lowest for sucrose+MLE (43.22 ± 17.47) and maltose+MLE (49.23 ± 22.39), intermediate for maltodextrin+MLE (75.90 ± 26.01), and higher for glucose+MLE (91.88 ± 27.24). MLE reduced the GIs for maltose, sucrose, maltodextrin, and glucose by 53.11%, 33.51%, 31.00%, and 8.12%, respectively. MLE was well tolerated.ConclusionsCoconsumption of MLE with sucrose, maltose, or maltodextrin can reduce the GI values of these carbohydrates.Trial RegistrationChinese Clinical Trial Registry Platform, no. ChiCTR-IPR-15006484. Registered on May 28, 2015.

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