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KMID : 1039620150050040455
Korean Journal of Family Practice
2015 Volume.5 No. 4 p.455 ~ p.460
The Pilot Study to Verify the Safety and Efficacy of the Short-Term Dose Escalating Oral Administration of Silk Peptide Functional Material on Glycemic Control in Healthy Male Subjects
Choi Joon-Young

Ahn Eun-Kyeong
Kim Ji-Min
Kim Kyung-Soo
Abstract
Background : The objective of this study was to verify the efficacy and safety of short-term, dose-escalating, oral administration of silk peptide functional material on glycemic control in healthy male subjects.

Methods : This study was conducted on 15 subjects selected by the screening of 23 volunteers who agreed to participate in the trial. Safety was assessed by the monitoring vital signs, physical examination, and testing for adverse reactions at baseline at 4, 12, and 24 hours after administration. Efficacy was assessed by measuring blood glucose, C-peptide, and insulin at baseline, before and after meals and at endpoint.

Results : After safety assessment, changes in systolic blood pressure, pulse rate, and body temperature were not statistically significant, but those of diastolic blood pressure were statistically significant. Adverse reactions were not observed. In the efficacy assessment, the changes of glucose, C-peptide, and insulin during study period were statistically significant. To examine the difference in dose, the variables were measured before and after administration. The average measured values of glucose were statistically significant at all measurement points, but those of C-peptide, and insulin were statistically significant only before and after breakfast.

Conclusion : Based on the results, the average measured values of glucose were statistically significant at all measurement points, but those of C-peptide and insulin were statistically significant only before and after breakfast. Thus, silk peptide functional material is considered potentially safe and effective for glycemic control.
KEYWORD
Silk Peptide, Efficacy, Safety, Glycemic Control
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