Safety and Tolerability of HemoHIM: A Randomized, Placebo-Controlled, Double-Blind, and Parallel Clinical Trial in Healthy Human Volunteers.

Abstract

HemoHIM is a mixed extract derived from the roots of oriental medicinal herbs. Despite many studies on HemoHIM's antioxidant properties and its effect on immune functions, fatigue reduction, and exercise performance, published data regarding its physiological safety in humans are lacking. Therefore, this study aimed to investigate the safety profile of HemoHIM in humans. The samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) with ultra-high-performance LC coupled to an Orbitrap MS. Data processing and compound identification were performed through nontargeted screening using multiple spectral databases. Ninety-six healthy adults were recruited in the clinical study. On visit 1, screening was conducted to assess eligibility. On visit 2, participants were randomly assigned to either the HemoHIM group (n = 48) or the placebo group (n = 48), and they consumed 40 g/day either HemoHIM or placebo supplements twice daily for 8 week. Participants visited the laboratory four times for body composition, compliance, dietary intake, vital signs, blood and urine biomarker, and adverse event assessment. Several bioactive compounds were successfully identified using LC-heated electrospray ionization-Orbitrap-MS/MS, including chlorogenic acid, paeoniflorin, decursin, and nodakenin. No clinically significant changes were found in the safety test of vital signs, blood and urine biomarkers, and adverse events. Based on these findings, HemoHIM could be a safe and beneficial natural compound mixture for human use.