Validation of green tea polyphenol biomarkers in a phase II human intervention trial

Food and Chemical Toxicology

Volumn 46, Issue 1, 2008, Pages 232-240

  Wang, Jia Sheng ^a   Luo, Haitao ^a   Wang, Piwen ^a   Tang, Lili ^a   Yu, Jiahua ^b   Huang, Tianren ^b   Cox, Stephen ^a   Gao, Weimin ^a  

^a TEXAS TECH UNIVERSITY   (United States)

^b Guangxi Cancer Institute   (China)

Author keywords

Biomarker; Glucuronidation; Green tea polyphenols; Intervention; Sulfation

Indexed keywords

BIOLOGICAL MARKER; EPICATECHIN; EPICATECHIN GALLATE; EPIGALLOCATECHIN; EPIGALLOCATECHIN GALLATE; GREEN TEA EXTRACT;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFECT; DRUG METABOLISM; HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TEA;

ADULT; BIOLOGICAL MARKERS; CATECHIN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLAVONOIDS; GUANOSINE TRIPHOSPHATE; HUMANS; MALE; MIDDLE AGED; PHENOLS; REPRODUCIBILITY OF RESULTS; TEA;

ANIMALIA;

EID: 36849003974     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2007.08.007     Document Type: Article

References (46)

1. Ahmad N., and Mukhtar H. Green tea polyphenols and cancer: biologic mechanisms and practical implications. Nutr. Rev. 57 (1999) 78-83
2. Bettuzzi S., Brausi M., Rizzi F., Castagnetti G., Peracchia G., and Corti A. Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Res. 66 (2006) 1234-1240
3. Brunner E., Domhof S., and Langer F. Nonparametric Analysis of Longitudinal Data in Factorial Experiments (2002), John Wiley, New York, NY
4. Chan D.K., Woo J., Ho S.C., Pang C.P., Law L.K., Ng P.W., Hung W.T., Kwok T., Hui E., Orr K., Leung M.F., and Kay R. Genetic and environmental risk factors for Parkinson's disease in a Chinese population. J. Neurol. Neurosurg. Psychiatry 65 (1998) 781-784
5. Chou F.P., Chu Y.C., Hsu J.D., Chiang H.C., and Wang C.J. Specific induction of glutathione S-transferase GSTM2 subunit expression by epigallocatechin gallate in rat liver. Biochem. Pharmacol. 60 (2000) 643-650
6. Chow H.H., Cai Y., Alberts D.S., Hakim I., Dorr R., Shahi F., Crowell J.A., Yang C.S., and Hara Y. Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and polyphenon E. Cancer Epidemiol. Biomarkers Prev. 10 (2001) 53-58
7. Chung J.Y., Huang C., Meng X., Dong Z., and Yang C.S. Inhibition of activator protein 1 activity and cell growth by purified green tea and black tea polyphenols in H-ras-transformed cells: structure-activity relationship and mechanisms involved. Cancer Res. 59 (1999) 4610-4617
8. Feng W.Y. Metabolism of green tea catechins: an overview. Curr. Drug Metab. 7 (2006) 755-809
9. Higdon J.V., and Frei B. Tea catechins and polyphenols: health effects, metabolism, and antioxidant functions. Crit. Rev. Food Sci. Nutr. 43 (2003) 89-143
10. Hollman P.C., Feskens E.J., and Katan M.B. Tea flavonols in cardiovascular disease and cancer epidemiology. Proc. Soc. Exp. Biol. Med. 220 (1999) 198-202
11. Huang T., Yu J., Tang L., Luo H., Billam M., Wei Z., Liang Y., Li Y., Wang K., Shi J., Cui Y., Zhang Z.Q., Zhang L., Sun S., Martin C., and Wang J.S. Phase IIa chemoprevention trial of green tea polyphenols in high-risk individuals of liver cancer: I. Design, clinical outcomes, and baseline biomarker data. Int. J. Cancer Prev. 1 (2004) 269-280
12. Isbrucker R.A., Bausch J., Edwards J.A., and Wolz E. Safety studies on epigallocatechin gallate (EGCG) preparations. Part 1: genotoxicity. Food Chem. Toxicol. 44 (2006) 626-635
13. Isbrucker R.A., Edwards J.A., Wolz E., Davidovich A., and Bausch J. Safety studies on epigallocatechin gallate (EGCG) preparations. Part 2: dermal, acute and short-term toxicity studies. Food Chem. Toxicol. 44 (2006) 636-650
14. Isbrucker R.A., Edwards J.A., Wolz E., Davidovich A., and Bausch J. Safety studies on epigallocatechin gallate (EGCG) preparations. Part 3: teratogenicity and reproductive toxicity studies in rats. Food Chem. Toxicol. 44 (2006) 651-661
15. Khan S.G., Katiyar S.K., Agarwal R., and Mukhtar H. Enhancement of antioxidant and phase II enzymes by oral feeding of green tea polyphenols in drinking water to SKH-1 hairless mice: possible role in cancer chemoprevention. Cancer Res. 52 (1992) 4050-4052
16. Lambert J.D., and Yang C.S. Cancer chemopreventive activity and bioavailability of tea and tea polyphenols. Mutat. Res. (2003) 201-208
17. Lee M.J., Maliakal P., Chen L., Meng X., Bondoc F.Y., Prabhu S., Lambert G., Mohr S., and Yang C.S. Pharmacokinetics of tea catechins after ingestion of green tea and (-)-epigallocatechin-3-gallate by humans: formation of different metabolites and individual variability. Cancer Epidemiol. Biomarkers Prev. 11 (2002) 1025-1032
18. Lee M.J., Prabhu S., Meng X., Li C., and Yang C.S. An improved method for the determination of green and black tea polyphenols in biomatrices by high-performance liquid chromatography with coulometric array detection. Anal. Biochem. 279 (2000) 164-169
19. Lee M.J., Wang Z.Y., Li H., Chen L., Sun Y., Gobbo S., Balentine D.A., and Yang C.S. Analysis of plasma and urinary tea polyphenols in human subjects. Cancer Epidemiol. Biomarkers Prev. 4 (1995) 393-399
20. Li C., Lee M.J., Sheng S., Meng X., Prabhu S., Winnik B., Huang B., Chung J.Y., Yan S., Ho C.T., and Yang C.S. Structural identification of two metabolites of catechins and their kinetics in human urine and blood after tea ingestion. Chem. Res. Toxicol. 13 (2000) 177-184
21. Li C., Meng X., Winnik B., Lee M.J., Lu H., Sheng S., Buckley B., and Yang C.S. Analysis of urinary metabolites of tea catechins by liquid chromatography/electrospray ionization mass spectrometry. Chem. Res. Toxicol. 14 (2001) 702-707
22. Lu H., Meng X., Li C., Sang S., Patten C., Sheng S., Hong J., Bai N., Winnik B., Ho C.T., and Yang C.S. Glucuronides of tea catechins: enzymology of biosynthesis and biological activities. Drug Metab. Dispos. 31 (2003) 452-461
23. Lu H., Meng X., and Yang C.S. Enzymology of methylation of tea catechins and inhibition of catechol-O-methyltransferase by (-)-epigallocatechin gallate. Drug Metab. Dispos. 31 (2003) 572-579
24. Luo H., Cox S.B., Gao W., Yu J., Tang L., and Wang J.S. Metabolic profiling in validation of plasma biomarkers for green tea polyphenols. Metabolomics 2 (2006) 235-241
25. Luo H., Tang L., Tang M., Billam M., Huang T., Yu J., Wei Z., Liang Y., Wang K., Zhang Z.Q., Zhang L., and Wang J.S. Phase IIa chemoprevention trial of green tea polyphenols in high-risk individuals of liver cancer: modulation of urinary excretion of green tea polyphenols and 8-hydroxydeoxyguanosine. Carcinogenesis 27 (2006) 262-268
26. Maas C.J.M., and Hox J.J. Robustness issues in multilevel regression analysis. Stat. Neerl. 58 (2004) 127-137
27. Meng X., Lee M.J., Li C., Sheng S., Zhu N., Sang S., Ho C.T., and Yang C.S. Formation and identification of 4′-O-methyl-(-)-epigallocatechin in humans. Drug Metab. Dispos. 29 (2001) 789-793
28. Meng X., Sang S., Zhu N., Lu H., Sheng S., Lee M.J., Ho C.T., and Yang C.S. Identification and characterization of methylated and ring-fission metabolites of tea catechins formed in humans, mice, and rats. Chem. Res. Toxicol. 15 (2002) 1042-1050
29. Nomura M., Ma W., Chen N., Bode A.M., and Dong Z. Inhibition of 12-O-tetradecanoylphorbol-13-acetate-induced NF-kappaB activation by tea polyphenols, (-)-epigallocatechin gallate and theaflavins. Carcinogenesis 21 (2000) 1885-1890
30. Pinheiro J., and Bates D. Mixed-Effects Models in S and S-Plus (2000), Springer Verlag, New York, NY
31. R Development Core Team, 2006. A language and environment for statistical computing, vol. R, Foundation for Statistical Computing: Vienna, Austria.
32. Sang S., Lambert J.D., Hong J., Tian S., Lee M.J., Stark R.E., Ho C.T., and Yang C.S. Synthesis and structure identification of thiol conjugates of (-)-epigallocatechin gallate and their urinary levels in mice. Chem. Res. Toxicol. 18 (2005) 1762-1769
33. Sang S., Lee M.J., Hou Z., Ho C.T., and Yang C.S. Stability of tea polyphenol (-)-epigallocatechin-3-gallate and formation of dimers and epimers under common experimental conditions. J. Agric. Food Chem. 53 (2005) 9478-9484
34. Singer, J.D., Willett, J.B., 2003. Applied Longitudinal Data Analysis:Modeling Change and Event Occurrence. Oxford University Press: Oxford, UK.
35. Southern Research Institute, 2005. IND safety report on preliminary findings in nine-month oral capsule chronic toxicity study of polyphenon E in Beagle dogs.
36. Sun C.L., Yuan J.M., Koh W.P., and Yu M.C. Green tea, black tea and breast cancer risk: a meta-analysis of epidemiological studies. Carcinogenesis 27 (2006) 1310-1315
37. Sun C.L., Yuan J.M., Koh W.P., and Yu M.C. Green tea, black tea and colorectal cancer risk: a meta-analysis of epidemiologic studies. Carcinogenesis 27 (2006) 1301-1309
38. Sun C.L., Yuan J.M., Lee M.J., Yang C.S., Gao Y.T., Ross R.K., and Yu M.C. Urinary tea polyphenols in relation to gastric and esophageal cancers: a prospective study of men in Shanghai, China. Carcinogenesis 23 (2002) 1497-1503
39. USNIH, 2000. Guideline of Chemoprevention Trials. National Institute of Health: Bethesda, MD.
40. Vaidyanathan J.B., and Walle T. Glucuronidation and sulfation of the tea flavonoid (-)-epicatechin by the human and rat enzymes. Drug Metab. Dispos. 30 (2002) 897-903
41. Yamada H., and Watanabe H. Tea polyphenols in preventing cardiovascular diseases. Cardiovasc. Res. 73 (2007) 439-440
42. Yang C.S., Chen L., Lee M.J., Balentine D., Kuo M.C., and Schantz S.P. Blood and urine levels of tea catechins after ingestion of different amounts of green tea by human volunteers. Cancer Epidemiol. Biomarkers Prev. 7 (1998) 351-354
43. Yang C.S., Maliakal P., and Meng X. Inhibition of carcinogenesis by tea. Annu. Rev. Pharmacol. Toxicol. 42 (2002) 25-54
44. Yang C.S., Lambert J.D., Hou Z., Ju J., Lu G., and Hao X. Molecular targets for the cancer preventive activity of tea polyphenols. Mol. Carcinog. 45 (2006) 431-435
45. Yuan J.M., Gao Y.T., Yang C.S., and Yu M.C. Urinary biomarkers of tea polyphenols and risk of colorectal cancer in the Shanghai cohort study. Int. J. Cancer. 120 (2007) 1344-1350
46. Zhao B., Guo Q., and Xin W. Free radical scavenging by green tea polyphenols. Methods Enzymol. 335 (2001) 217-231