title: Studies of the toxicological potential of capsinoids: X. Safety assessment and pharmacokinetics of capsinoids in healthy male volunteers after a single oral ingestion of CH-19 Sweet extract.
abstract: The safety and pharmacokinetics of capsinoids, physiologically active ingredients of CH-19 Sweet extract, were investigated in 16 healthy male volunteers following a single oral ingestion of CH-19 Sweet extract. The study subjects consumed soft gel capsules containing either capsinoids (15 or 30 mg/person) or placebo. Capsinoids were well tolerated, and no clinically significant changes in physical examinations, blood pressure, heart rate, body temperature, electrocardiogram, hematology, blood chemistry, and urinalysis were observed at either the 15 or 30 mg dose. Body temperature tended to increase after the ingestion of capsinoids, but remained within the normal range. Plasma levels of capsinoids and their metabolite, vanillyl alcohol, were below the lower limit of quantitation. In addition, some study subjects showed increases in urinary excretion of 3-methoxy-4-hydroxyphenylglycol that, when compared to the group receiving the placebo, did not achieve statistical significance.
authors.affiliation: SRA International, Inc., Cambridge, Maryland 21613, USA. Bernard@sra-intl.com
authors.forename: Bruce K
authors.initials: BK
authors.lastname: Bernard
authors.forename: Shoji
authors.initials: S
authors.lastname: Tsubuku
authors.forename: Takashi
authors.initials: T
authors.lastname: Kayahara
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Maeda
authors.forename: Minoru
authors.initials: M
authors.lastname: Hamada
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakamura
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shirai
authors.forename: Akira
authors.initials: A
authors.lastname: Nakayama
authors.forename: Satoko
authors.initials: S
authors.lastname: Ueno
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Mihara
mesh_terms: D000284:Administration, Oral; D001794:Blood Pressure; D001831:Body Temperature; D002212:Capsicum / Q000737:chemistry*; D004311:Double-Blind Method; D004562:Electrocardiography; D006339:Heart Rate; D006801:Humans; D008297:Male; D010919:Placebos; D010936:Plant Extracts / Q000097:blood / Q000493:pharmacokinetics* / Q000633:toxicity*; D012016:Reference Values
chemical_list: D010919:Placebos; D010936:Plant Extracts