Poster Topical Area: Dietary Bioactive Components
Location: Hall D
Poster Board Number: 302
A randomized, double-blind, crossover placebo-controlled study on preventive effects, safety, and efficacy of oral supplementation of Amla (Emblica Officinalis Gatertn.) in healthy human subjects
Mahendra P. Kapoor 1*, Ph.D., Tsutomu Okubo 1, Ph.D., Koji Suzuki 2,3, Ph.D.,
1Nutrition Division, Taiyo Kagaku Co. Ltd., 1-3 Takaramachi, Yokkaichi, Mie 510-0844, Japan. 2Department of Molecular Pathobiology, Mie University, 2-174 Edobashi, Tsu City, Mie 514 8507, Japan. 3Suzuka University of Medical Sciences, Mie University, Suzuka City, Mie 510-0221, Japan.
Objective: Amla (Emblica Officinalis Gaertn), an edible Indian fruit has been used in traditional Ayurvedic formulations for the medicinal system. We investigated the preventive effect of the oral administration standardized formulation of amla supplementation (SunAmla-PD1) on vascular functions, blood hematology, glucose and lipid profiles, oxidative and inflammatory biomarkers, urinalysis, and liver hepatotoxicity safety in adult healthy humans.
Methods: Fourteen (14) subjects aged between 36 to 67 years completed the study of 18 weeks of total duration, received placebo and SunAmla-PD1 (500 mg/day) according to study protocols. Differences during the study period were identified (P ≤ 0.05) using a repeated measure analysis of variance (ANOVA) for within-group effect. Group differences were identified (P ≤ 0.05) using cofactor analysis of variance (ANCOVA) at each sampling time point.
Results: The results indicate that SumAmla-PD1 improves the blood fluidity, lowers von Willebrand factor (vWF), and reduces 8-OHdG and soluble thrombomodulin (TM) concentration along with a significant increase in HDL-cholesterol and lowering the LDL- cholesterol level. No meaningful, significant abnormal clinical changes could be observed after test supplement SumAmla-PD1 intake on hematology or liver hepatotoxicity or urinalysis examinations, confirm the safety-related aspects of the SumAmla-PD1. Also, no adverse events have been induced by the test supplement was observed throughout the study duration.
Conclusion: In summary, oral intake of SunAmla-PD1 has good acceptability and safe for consumption to lead the healthy lifestyle.
Deputy General Manager
Taiyo Kagaku Co. Ltd. Japan
Yokkaichi, Mie, Japan