A single ascending dose study of epigallocatechin gallate in healthy volunteers

Journal of International Medical Research

Volumn 31, Issue 2, 2003, Pages 88-101

  Ullmann, U ^a   Haller, J ^a   Decourt, J P ^b   Girault, N ^b   Girault, J ^b   Richard Caudron, A S ^b   Pineau, B ^b   Weber, P ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b CEMAF   (France)

Author keywords

Catechins; Epigallocatechin gallate; Green tea; Healthy volunteers; Pharmacokinetics; Phase I; Polyphenols

Indexed keywords

CRYSTALLIN; EPICATECHIN; EPIGALLOCATECHIN; EPIGALLOCATECHIN GALLATE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; STRUCTURE ACTIVITY RELATION;

EID: 0038706103     PISSN: 03000605     EISSN: None     Source Type: Journal    
DOI: 10.1177/147323000303100205     Document Type: Article

References (37)

1. Tijburg LB, Mattern T, Folts JB, Weigerber UM, Katan MB: Tea flavonoids and cardiovascular disease: a review. Crit Rev Food Sci Nutr 1997; 37: 771-785.
2. Kao YH, Hiipakka RA, Liao S. Modulation of endocrine systems and food intake by green tea epigallocatechin gallate. Endocrinology 2000; 141: 980-987.
3. Judd JT, Davies MJ, Baer DJ, Chen SC, Wiseman S, Agarwal S: Black tea consumption reduces total and LDL cholesterol in male hyper-cholesterolemic adults (abstract). FASEB J 2002; 16: A238.
4. Kono S, Shinchi K, Wakabayashi K, Honjo S, Todoroki I, Sakurai Y, et al: Relation of green tea consumption to serum lipids and lipoproteins in Japanese men. J Epidemiol 1996; 6: 128-133.
5. Kono S, Shinchi K, Ikeda N, Yanai F, Imanishi K: Green tea consumption and serum lipid profiles: a cross-sectional study in Northern Kyushu, Japan. Prev Med 1992; 21: 526-531.
6. Imai K, Nakachi K: Cross sectional study of effects of drinking green tea on cardiovascular and liver diseases. Br Med J 1995; 310: 693-696.
7. Yokozawa T, Oura H, Nakagawa H, Sakanaka S, Kim M: Effects of a component of green tea on the proliferation of vascular smooth muscle cells. Biosci Biotechnol Biochem 1995; 59: 2134-2136.
8. Sachnidis A, Skach RA, Seul C, Ko Y, Hescheler J, Ahn AJ, et al: Inhibition of the PDGF beta-receptor tyrosine phosphorylation and its downstream intracellular signal transduction pathway in rat and human vascular smooth muscle cells by different catechins (abstract). FASEB J 2002; 16: 893-895.
9. Kang WS, Lim IH, Yuk DJ, Chung KH, Parks JB, Yoo HS, et al: Antithrombotic activities of green tea catechins and (-)-epigallocatechin gallate. Thromb Res 1999; 96: 229-237.
10. Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, et al: Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr 1999; 70: 1040-1045.
11. Dulloo AG, Seydoux J, Girardier L, Chantre P, Vandermander J: Green tea and thermogenesis: interactions between catechin-polyphenols, caffeine and sympathetic activity. Int J Obes Relat Metab Disord 2000; 24: 252-258.
12. Rumpler W, Seale J, Clevidence B, Judd J, Wiley E, Yamamoto S, et al: Oolong tea increases metabolic rate and fat oxidation in men. J Nutr 2001; 131: 2848-2852.
13. Nakachi K, Matasuyama S, Miyake S, Suganuma M, Imai K: Preventive effects of drinking green tea on cancer and cardiovascular disease: epidemiological evidence for multiple targeting prevention. Biofactors 2000; 13: 49-54.
14. Liao S, Kao YH, Hiipakka A: Green tea: biochemical and biological basis for health benefits. Vitam Horm 2001; 62: 92-94.
15. Pietta P, Simonetti P, Roggi C, Brusamolino A, Pellegrini N, Maccarini L, et al: Dietary flavonoids and oxidative stress. Proc R Chem Soc 1996; 181: 249-255.
16. Weisburger JH: Tea and health: the underlying mechanisms. Proc Soc Exp Biol Med 1999; 220: 271-275.
17. Lin JK, Lin CL, Liang YC, Lin-Shiau SY, Juan IM: Survey of catechins, gallic acid, and methyl-xanthines in green, oolong, pu-erh and black teas. J Agric Food Chem 1998; 46: 3635-3642.
18. Committee for Proprietary Medicinal Products (CPMP), European Agency for the Evaluation of Medicinal Products (EMEA): CPMP/EWP/QWP/1401/98. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, 2002.
19. Food and Drug Administration (FDA): Guidance on Statistical Procedures for Bioequivalence Studies Using Standard Two-treatment Crossover Design. Informal communication by the Division of Bioequivalence, Office of Generic Drugs, FDA, Rockville, Maryland, USA, 1992.
20. Sauter R, Seinijans VW, Diletti E, Böhm A, Schulz HU: Presentation of results from bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1992; 30: 233-256.
21. Committee for Proprietary Medicinal Products (CPMP), European Agency for the Evaluation of Medicinal Products (EMEA): III/3630/92-EN 1995. Biostatistical Methodology in Clinical Trials in Application for Marketing Authorisation for Medicinal Products, 1995.
22. Chen L, Lee MJ, Li H, Yang CS: Absorption, distribution and elimination of tea polyphenols in rats. Drug Metab Dispos 1997; 25: 1045-1050.
23. Kim DC, Lim JS: Pharmacokinetic study of epigallocatechin gallate in rats. J Kor Pharm Sci 1999; 29: 179-184.
24. Zuhu M, Chen Y, Li R: Oral absorption and bioavailability of tea catechins. Planta Med 2000; 66: 444-447.
25. Nackagawa K, Miyazawa T: Absorption and distribution of tea catechin (-)-epigallocatechin-3-gallate in the rat. J Nutr Sci Vitaminol 1997; 43: 679-684.
26. Unno T, Takeo T: Absorption of (-)-epigallocatechin gallate into the circulation system of rats. Biosci Biotechnol Biochem 1995; 59: 1558-1559.
27. 3H-epigallocatechin gallate (EGCG) in beagle dogs after intravenous (iv) and oral dose administration. Toxicologist 2001; 60: 341.
28. Hara Y: Influence of tea catechins on the digestive tract. J Cell Biochem Suppl 1997; 27: 52-58.
29. 3H]epigallocatechin gallate in rats after oral administration. J Agric Food Chem 2001; 49: 4102-4112.
30. 3H]epigallocatechin gallate and its metabolic fate in rats after intravenous administration. J Agric Food Chem 2001; 49: 1042-1048.
31. Kida K, Suzuki M, Matsumoto N, Nanjo F, Hara Y: Identification of biliary metabolites of (-)-epigallocatechin gallate in rats. J Agric Food Chem 2000; 48: 4151-4155.
32. Lee MJ, Wang ZY, Li H, Chen L, Sun Y, Gobbo S, et al: Analysis of plasma and urinary tea polyphenols in human subjects. Cancer Epidemiol Biomarkers Prev 1995; 4: 393-399.
33. Yang CS, Chen L, Leem J, Balentine DA, Kuo MC, Schantz S: Blood and urine levels of tea catechins after ingestion of different amounts of green tea by human volunteers. Cancer Epidemiol Biomarkers Prev 1998; 71: 103-108.
34. Unno T, Kondo K, Itakura H, Takeo T: Analysis of (-)-epigallocatechin gallate in human serum obtained after ingesting green tea. Biosci Biotechnol Biochem 1996; 60: 2066-2068.
35. Nakagawa K, Okuda S, Miyazawa T: Dose-dependent incorporation of tea catechins, (-)-epigallocatechin-3-gallate and (-)-epigallocatechin, into human plasma. Biosci Biotechnol Biochem 1997; 61: 1981-1985.
36. Van Amelsvoort JM, van Hof KH, Mathot JN, Mulder TP, Wiersma A, Tijburg LB: Plasma concentrations of individual tea catechins after a single oral dose in humans. Xenobiotica 2001; 31: 891-901.
37. Chow HH, Cai Y, Alberts DS, Hakim I, Dorr R, Shahi F, et al: Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and polyphenon E. Cancer Epidemiol Biomarkers Prev 2001; 10: 53-58.