Pharmacokinetics, Safety and Tolerability of Melissa officinalis Extract which Contained Rosmarinic Acid in Healthy Individuals: A Randomized Controlled Trial

Abstract

The aim of this study was to evaluate the safety, tolerability and pharmacokinetics of single dose of Melissa officinalis extract which contained rosmarinic acid, including food-effects in healthy individuals. A total of eleven healthy individuals were randomly assigned to treatment arms in the two studies [Study 1 (fasted state) and Study 2 (fed state)]. Rosmarinic acid in serum was measured by a coulometric detection method using High-Performance Liquid Chromatography electrochemical detector. The serum concentration of total rosmarinic acid peaked at 1 hour after administration of Melissa officinalis extract containing 500mg rosmarinic acid in fasted state, with a maximum serum concentration 162.20 nmol/ L. The area under the curve for intact rosmarinic acid was calculated from the serum concentration-time profile to be 832.13 nmol • hour/ L. Food intake increases area under the curve and delayed time at which the maximum serum concentration. Rosmarinic acid supplementation did not affect liver, kidney, or blood cell function parameters. No adverse event was reported by any of the participants due to the study treatment. Single dose of Melissa officinalis extract containing 500 mg rosmarinic acid appears to be safe and tolerable in healthy individuals. Food intake increased the exposure of rosmarinic acid and delayed absorption of rosmarinic acid in healthy individuals.Trial RegistrationTrial Registration: UMIN-CTR UMIN000004997

Antioxidant Activity of Oral Administration of Rosmarinus Officinalis Leaves Extract on Rat's Hippocampus which Exposed to 6-Hydroxydopamine

“…Reducing free-radicals from cigarette smoke by using a filter impregnated by an extract of a rosemary plant in oil was reported (Alexandrov et al 2006). Rosmarinic acid could exert its neuroprotective and anti-oxidative effects against 6-OHDA-induced neurotoxicity in dopaminergic neurons (Ren et al 2009;Wang et al 2012;Noguchi et al 2015). Our results also demonstrated that RE at dose of 50 mg/kg body weight could decrease oxidative stress by increasing the activities of SOD, CAT and GPx in hippocampus resulting in the decrease of lipid peroxidation level in lesioned region.…”

Lemon Balm and Its Constituent, Rosmarinic Acid, Alleviate Liver Damage in an Animal Model of Nonalcoholic Steatohepatitis

“…1 filter paper (GE Healthcare Life Sciences, Pittsburgh, PA, USA). RA was identified from lemon balm (3.59% in lemon balm extract, LBE) as described previously [18].…”

The Effect of Rosmarinic Acid on Immunological and Neurological Systems: A Basic Science and Clinical Review

“…36 Acceptable daily intake (ADI) is a measure of the amount of a specific substance in that can be orally consumed on daily basis, over a lifetime without an appreciable health risk. 37 An ADI value can be calculated from the no observed adverse effect level (NOAEL). 37 In a study using AD model transgenic mice, RosA exhibited no adverse effect at a level of 1 g/kg in the study.…”

“…37 An ADI value can be calculated from the no observed adverse effect level (NOAEL). 37 In a study using AD model transgenic mice, RosA exhibited no adverse effect at a level of 1 g/kg in the study. 37 Assuming a human weight of 50 kg, NOAEL was determined as 50 g per day.…”