| Summary: | Tania Reyes-Izquierdo,1 Boris Nemzer,2 Ruby Argumedo,1 Cynthia Shu,1 Zb Pietrzkowski1 1Applied BioClinical Inc., Irvine, CA, 2FutureCeuticals Inc, Momence, IL, USA Background: Dermaval™ is a composite formulation of various phytochemical-rich plant materials as quantified using high-performance liquid chromatography. This blend exerts inhibitory activity on human neutrophil elastase (HNE). An acute, crossover clinical study was performed to assess the effects of Dermaval on glucose-induced HNE activity in 20 healthy subjects. Methods: Participants served as their own controls during this 3-day trial. On day 1, all study participants were fasted and given only 300 mL of water. Blood was drawn before treatment and 60 and 120 minutes post treatment. On day 2, participants were fasted, treated with 75 g of glucose, and similarly tested. On day 3, participants consumed a 50 mg serving of Dermaval followed by 75 g of glucose 15 minutes later. HNE concentration and HNE total activity were determined using enzyme-linked immunosorbent assay. Results: Average values for HNE activity in the control group (day 1) did not change. Treatment with a single dose of glucose (day 2) increased blood HNE activity by 175% over baseline levels (P=0.005) during the first 60 minutes. Pretreatment with Dermaval on day 3 prevented the glucose-induced increase in HNE activity (P=0.005 at 60 minutes and P=0.03 at 120 minutes versus respective day 2 values). Interestingly, ingestion of 75 g of glucose resulted in the same blood glucose levels on days 2 and 3, indicating that ingestion of Dermaval did not affect glucose absorption. Conclusion: These results suggest that Dermaval acutely inhibits glucose-induced HNE activity. Further investigations are needed to elucidate the direct and/or indirect mechanism of this effect and to verify whether treatment with Dermaval without glucose may acutely affect activity of HNE as well. Keywords: crossover study, human neutrophil elastase, glucose
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