![]() The purpose of this study was to evaluate the potential beneficial effects of paraxanthine supplementation on muscle mass, strength, and endurance performance in comparison to the control and other ingredients commonly used by athletes: L-theanine, alpha-GPC, and taurine. Compared to caffeine, paraxanthine exhibits lower toxicity, lesser anxiogenic properties, stronger locomotor activating effects, greater wake promoting properties, and stronger dopaminergic effects. Paraxanthine is a natural dietary ingredient and the main metabolite of caffeine in humans. These findings may suggest that paraxanthine could be a safer alternative to caffeine in humans. ![]() Therefore, the no observed adverse effect level (NOAEL) from the 90-day study was determined to be 150 mg/kg bw for caffeine and 185 mg/kg bw for paraxanthine for both male and female Sprague Dawley rats. However, mortality was reported in two animals in the high dose caffeine-treated animals. The same findings were observed in the subchronic repeat-dose 90-day oral toxicity study at daily doses of paraxanthine of 100, 150, or 185 mg/kg bw which were compared to caffeine at 150 or 185 mg/kg bw ( n = 10 animals/sex/group). There was no mortality or treatment-related adverse effects in the 14-day repeat dose oral toxicity study, wherein rats received low, mid, or high doses of paraxanthine (50, 100, or 150 mg/kg bw, n = 5 rats/sex/group). An acute oral LD 50 of 829.20 mg/kg body weight (bw) was established. Results/Discussion: There was no evidence of genetic toxicity or mutagenicity in the in vitro studies. These studies evaluated the potential mutagenicity (bacterial reverse mutation, in vitro mammalian chromosomal aberration), genetic toxicity ( in vitro mammalian cell gene mutation) and acute, sub-acute and sub-chronic oral toxicity of paraxanthine in Sprague Dawley rats. Methods: The aim of this study was to evaluate the toxicity of paraxanthine (Rarebird, Inc.) relative to caffeine through a battery of toxicological studies conducted in accordance with international guidelines. The few toxicity studies that are available for paraxanthine suggest that the molecule is relatively safe, although thorough characterization of its safety is required prior to widespread incorporation into foods/beverages. Paraxanthine (1,7-dimethylxanthine) is the predominant metabolite of caffeine in humans with similar stimulant properties. Thus, investigation into an alternate stimulant with similar pharmacology but improved safety is warranted. Caffeine safety has been the subject of a safety workshop by FDA and the Institute of Medicine in the past decade. As a member of the methylxanthine class of stimulants, caffeine is not devoid of unwanted side effects at any serving level. Introduction: Caffeine, one of the most ubiquitous ingredients found in beverages and other ingested food products, has a long history of safe use. ![]()
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