NDLI: Pharmacokinetic, partial pharmacodynamic and initial safety analysis of (−)-epicatechin in healthy volunteers

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Pharmacokinetic, partial pharmacodynamic and initial safety analysis of (−)-epicatechin in healthy volunteers

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Food & Function Vol - 6 Issue - 2

Food & Function Vol -5

Food & Function Vol -4

Food & Function Vol -3

Food & Function Vol -2

Food & Function Vol -1

Pharmacokinetic, partial pharmacodynamic and initial safety analysis of (−)-epicatechin in healthy volunteers

Content Provider	Royal Society of Chemistry (RSC)
Author	Barnett, Christopher F. Taub, Pam R. Villarreal, Francisco Ramirez-Sanchez, Israel Shiva, Sruti Ceballos, Guillermo Moreno-Ulloa, Aldo Dugar, Sundeep Su, Yongxuan Schreiner, George
Copyright Year	2015
Abstract	(−)-Epicatechin ((−)-EPI), a naturally occurring flavanol, has emerged as a likely candidate for cocoa-based product reported reductions in cardiometabolic risk. The present study aimed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of purified (−)-EPI administered to healthy volunteers. In this phase I, open-label, two-part single- and multiple-dose study, subjects received either a single dose (n = 9) of 50, 100 or 200 mg or multiple doses (n = 8) of 50 mg daily (q.d.) or twice daily (b.i.d) for 5 days. Blood was collected at 0, 0.5, 1, 2, 4 and 6 h after (−)-EPI administration in the single and multiple dose groups (blood collection repeated in day 5). Samples were analyzed by HPLC-HR-ESI-MS for EPI and metabolite quantification. In the q.d. and b.i.d. groups, blood samples were analyzed for NO surrogates and follistatin levels as well as, platelet mitochondrial complexes I, V and citrate synthase activity levels. (−)-EPI was well tolerated and readily absorbed with further phase 2 metabolism. On day 5, in the q.d. and b.i.d. groups, there were significant increases in plasma nitrite of 30% and 17%, respectively. In the q.d. group on day 5 vs. day 1, platelet mitochondrial complexes I, IV and citrate synthase activities demonstrated a significant increase of ∼92, 62 and 8%, respectively. Average day 5 follistatin AUC levels were ∼2.5 fold higher vs. day 1 AUC levels in the b.i.d. group. (−)-EPI was safe to use, with no observed adverse effects, and our findings suggest that increases in NO metabolites, mitochondrial enzyme function and plasma follistatin levels may underlie some of the beneficial effects of cocoa products or (−)-EPI as reported in other studies.
Starting Page	824
Ending Page	833
Page Count	10
File Format	HTM / HTML PDF
ISSN	20426496
Volume Number	6
Issue Number	3
Journal	Food & Function
DOI	10.1039/c4fo00596a
Language	English
Publisher	Royal Society of Chemistry
Access Restriction	Open
Subject Keyword	EPI AUC Epicatechin Catechin Flavan-3-ol Pharmacokinetics Pharmacodynamics Metabolite Follistatin Platelet Citrate synthase Metabolism Blood plasma Nitrite Enzyme Cocoa bean
Content Type	Text
Resource Type	Article
Subject	Medicine Food Science

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