BACKGROUND:Caffeine is the most widely used psychostimulant. PURPOSE: This study evaluated the pharmacokinetics and effects of mood and alertness of a single oral administration of 600 mg of a slow release caffeine (SRC) on a large group of healthy subjects. METHOD: In this double-blind, parallel-group study, 120 young adult males were randomly assigned to either a caffeine group (CG, n = 100) or a placebo group (PC, n = 20). After a normal sleep, each subject took 600 mg of a SRC or a placebo. Circulating caffeine was determined by salivary caffeine assays after acetylation phenotype categorization. Mood, alertness and nocturnal sleep were evaluated by visual analog scales (VAS). RESULTS: This SRC was well tolerated probably due to its relative low plasmatic Cmax (10.37 micrograms.ml-1). Between CG and PG, there were no differences for alertness, contentedness and sleep quality of the night after treatment (N2) compared to the previous night (N1). VAS scores showed a decrease in calmness in the CG (p < 0.01). Sleep latency in N2 was significantly increased with caffeine (p < 0.01). Calmness, sleep onset latency, quality of sleep onset and overall rating of N2 compared to N1 were correlated with caffeine levels, which were only influenced by tobacco consumption. CONCLUSIONS: Although a single oral dose of 600 mg of a SRC is well tolerated, further evaluation must be done on alertness and pharmacokinetics with fatigued subjects and with females using oral contraceptives.
RCT Entities:
BACKGROUND:Caffeine is the most widely used psychostimulant. PURPOSE: This study evaluated the pharmacokinetics and effects of mood and alertness of a single oral administration of 600 mg of a slow release caffeine (SRC) on a large group of healthy subjects. METHOD: In this double-blind, parallel-group study, 120 young adult males were randomly assigned to either a caffeine group (CG, n = 100) or a placebo group (PC, n = 20). After a normal sleep, each subject took 600 mg of a SRC or a placebo. Circulating caffeine was determined by salivary caffeine assays after acetylation phenotype categorization. Mood, alertness and nocturnal sleep were evaluated by visual analog scales (VAS). RESULTS: This SRC was well tolerated probably due to its relative low plasmatic Cmax (10.37 micrograms.ml-1). Between CG and PG, there were no differences for alertness, contentedness and sleep quality of the night after treatment (N2) compared to the previous night (N1). VAS scores showed a decrease in calmness in the CG (p < 0.01). Sleep latency in N2 was significantly increased with caffeine (p < 0.01). Calmness, sleep onset latency, quality of sleep onset and overall rating of N2 compared to N1 were correlated with caffeine levels, which were only influenced by tobacco consumption. CONCLUSIONS: Although a single oral dose of 600 mg of a SRC is well tolerated, further evaluation must be done on alertness and pharmacokinetics with fatigued subjects and with females using oral contraceptives.
Authors: Adam M Gonzalez; Jay R Hoffman; Adam J Wells; Gerald T Mangine; Jeremy R Townsend; Adam R Jajtner; Ran Wang; Amelia A Miramonti; Gabriel J Pruna; Michael B LaMonica; Jonathan D Bohner; Mattan W Hoffman; Leonardo P Oliveira; David H Fukuda; Maren S Fragala; Jeffrey R Stout Journal: J Sports Sci Med Date: 2015-05-08 Impact factor: 2.988