A randomized, double-blind, placebo-controlled trial to evaluate the hypoglycemic efficacy of the mcIRBP-19-containing Momordica charantia L. fruit extracts in the type 2 diabetic subjects

  • Yi-Sun Yang Department of Internal Medicine, Division of Endocrinology and Metabolism, Chung Shan Medical University Hospital, Taichung; and Department of Internal Medicine, School of Medicine, Chung Shan Medical University, Taichung, Taiwan
  • Nian-Yi Wu Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan
  • Edy Kornelius Department of Internal Medicine, Division of Endocrinology and Metabolism, Chung Shan Medical University Hospital, Taichung; and Department of Internal Medicine, School of Medicine, Chung Shan Medical University, Taichung, Taiwan
  • Chien-Ning Huang Department of Internal Medicine, Division of Endocrinology and Metabolism, Chung Shan Medical University Hospital, Taichung; and epartment of Internal Medicine, School of Medicine, Chung Shan Medical University, Taichung, Taiwan
  • Nae-Cherng Yang Department of Nutrition, Chung Shan Medical University, Taichung; and Department of Nutrition, Chung Shan Medical University Hospital, Taichung, Taiwan
Keywords: bitter gourd extracts, Momordica charantia insulin receptor binding peptide-19, type 2 diabetic subjects, fasting blood glucose, HbA1c

Abstract

Background: The fruits of Momordica charantia L., also named as bitter gourd or bitter melon in popular, is a common tropical vegetable that is traditionally used to reduce blood glucose. A peptide derived from bitter gourd, Momordica charantia insulin receptor binding peptid-19 (mcIRBP-19), had been demonstrated to possess an insulin-like effect in vitro and in the animal studies. However, the benefit of the mcIRBP-19-containing bitter gourd extracts (mcIRBP-19-BGE) for lowering blood glucose levels in humans is unknown.

Objective: This aim of this study was to evaluate the hypoglycemic efficacy of mcIRBP-19-BGE in subjects with type 2 diabetes who had taken antidiabetic medications but failed to achieve the treatment goal. Whether glucose lowering efficacy of mcIRBP-19-BGE could be demonstrated when the antidiabetic medications were ineffective was also studied.

Design: Subjects were randomly assigned to two groups: mcIRBP-19-BGE treatment group (N = 20) and placebo group (N = 20), and were orally administered 600 mg/day investigational product or placebo for 3 months. Subjects whose hemoglobin A1c (HbA1c) continued declining before the trial initiation with the antidiabetic drugs were excluded from the subset analysis to further investigate the efficacy for those who failed to respond to the antidiabetic medications.

Results: The oral administration of mcIRBP-19-BGE decreased with a borderline significance at fasting blood glucose (FBG; P = 0.057) and HbA1c (P = 0.060). The subgroup analysis (N = 29) showed that mcIRBP-19-BGE had a significant effect on reducing FBG (from 172.5 ± 32.6 mg/dL to 159.4 ± 18.3 mg/dL, P = 0.041) and HbA1c (from 8.0 ± 0.7% to 7.5 ± 0.8%, P = 0.010).

Conclusion: All of these results demonstrate that mcIRBP-19-BGE possesses a hypoglycemic effect, and can have a significant reduction in FBG and HbA1c when the antidiabetic drugs are ineffective.

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Published
2022-01-03
How to Cite
Yang, Y.-S., Wu, N.-Y., Kornelius, E., Huang, C.-N., & Yang, N.-C. (2022). A randomized, double-blind, placebo-controlled trial to evaluate the hypoglycemic efficacy of the mcIRBP-19-containing <em>Momordica charantia L. </em&gt;fruit extracts in the type 2 diabetic subjects. Food & Nutrition Research, 66. https://doi.org/10.29219/fnr.v66.3685
Section
Original Articles