The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: Results of the Minnesota Green TeaTrial

Food and Chemical Toxicology

Volumn 83, Issue , 2015, Pages 26-35

  Dostal, Allison M ^a   Samavat, Hamed ^a   Bedell, Sarah ^a   Torkelson, Carolyn ^b   Wang, Renwei ^c   Swenson, Karen ^d   Le, Chap ^e   Wu, Anna H ^f   Ursin, Giske ^f,g,h   Yuan, Jian Min ^c   Kurzer, Mindy S ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

^b UNIVERSITY OF MINNESOTA MEDICAL CENTER   (United States)

^c UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^d Virginia Piper Cancer Institute   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

^f UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^g CANCER REGISTRY OF NORWAY   (Norway)

^h UNIVERSITY OF OSLO   (Norway)

Author keywords

Adverse events; Breast cancer; EGCG; Green tea; Hepatotoxicity; Postmenopausal

Indexed keywords

ALANINE AMINOTRANSFERASE; EPIGALLOCATECHIN GALLATE; GREEN TEA EXTRACT; PLACEBO; ANTINEOPLASTIC AGENT; ANTIOXIDANT; BIOLOGICAL MARKER; CATECHIN; PLANT EXTRACT;

ADULT; ADVERSE OUTCOME; ARTICLE; BREAST CANCER; CANCER RISK; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIET SUPPLEMENTATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MUSCULOSKELETAL DISEASE; NAUSEA; NUTRITIONAL DISORDER; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SKIN DISEASE; THORAX DISEASE; TREATMENT OUTCOME; VASCULAR DISEASE; ABNORMALITIES; ADVERSE EFFECTS; AGED; ANALOGS AND DERIVATIVES; ANALYSIS; BLOOD; BREAST DENSITY; BREAST NEOPLASMS; CAMELLIA SINENSIS; CHEMISTRY; CLINICAL TRIAL; DIAGNOSTIC IMAGING; DIETARY SUPPLEMENT; FOOD HANDLING; HEPATIC INSUFFICIENCY; MAMMARY GLAND; MIDDLE AGED; MINNESOTA; MULTICENTER STUDY; PATHOPHYSIOLOGY; PLANT LEAF; RADIOGRAPHY; RISK FACTOR; SEVERITY OF ILLNESS INDEX;

AGED; ANTICARCINOGENIC AGENTS; ANTIOXIDANTS; BIOMARKERS; BREAST DENSITY; BREAST NEOPLASMS; CAMELLIA SINENSIS; CATECHIN; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; FEMALE; FOOD HANDLING; HEPATIC INSUFFICIENCY; HUMANS; MAMMARY GLANDS, HUMAN; MIDDLE AGED; MINNESOTA; PLANT EXTRACTS; PLANT LEAVES; RADIOGRAPHY; RISK FACTORS; SEVERITY OF ILLNESS INDEX;

EID: 84931287646     PISSN: 02786915     EISSN: 18736351     Source Type: Journal    
DOI: 10.1016/j.fct.2015.05.019     Document Type: Article

References (34)

1. Andrade J.P., Assuncao M. Protective effects of chronic green tea consumption on age-related neurodegeneration. Curr. Pharm. Des. 2012, 18(1):4-14.
2. Bhagwat S., Haytowitz D.B., Holden J.M. USDA Database for the Flavonoid Content of Selected Foods 2014, Report nr 3.
3. Chow H.H., Cai Y., Hakim I.A., Crowell J.A., Shahi F., Brooks C.A., Dorr R.T., Hara Y., Alberts D.S. Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallate and polyphenon E in healthy individuals. Clin. Cancer Res. 2003, 9(9):3312-3319.
4. Chow H.H., Hakim I.A., Vining D.R., Crowell J.A., Ranger-Moore J., Chew W.M., Celaya C.A., Rodney S.R., Hara Y., Alberts D.S. Effects of dosing condition on the oral bioavailability of green tea catechins after single-dose administration of polyphenon E in healthy individuals. Clin. Cancer Res. 2005, 11(12):4627-4633.
5. Church R.J., Gatti D.M., Urban T.J., Long N., Yang X., Shi Q., Eaddy J.S., Mosedale M., Ballard S., Churchill G.A., et al. Sensitivity to hepatotoxicity due to epigallocatechin gallate is affected by genetic background in diversity outbred mice. Food Chem. Toxicol. 2014, 76C:19-26.
6. Dawling S., Roodi N., Mernaugh R.L., Wang X., Parl F.F. Catechol-O-methyltransferase (COMT)-mediated metabolism of catechol estrogens: comparison of wild-type and variant COMT isoforms. Cancer Res. 2001, 61(18):6716-6722.
7. Emami H., Nikoobin F., Roayaei M., Ziya H.R. Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy. J.Res. Med. Sci. 2014, 19(5):445-450.
8. Galati G., Lin A., Sultan A.M., O'Brien P.J. Cellular and invivo hepatotoxicity caused by green tea phenolic acids and catechins. Free Radic. Biol. Med. 2006, 40(4):570-580.
9. Gallaher D.D.S.B. Dietary fiber. Present Knowledge in Nutrition 2001, 83. ILSI Press, Washington DC. B.A.R.R. Bowman (Ed.).
10. Hodgson J.M., Croft K.D. Tea flavonoids and cardiovascular health. Mol. Asp. Med. 2010, 31(6):495-502.
11. Huang J., Wang Y., Xie Z., Zhou Y., Zhang Y., Wan X. The anti-obesity effects of green tea in human intervention and basic molecular studies. Eur. J. Clin. Nutr. 2014 Oct, 68(10):1075-1087.
12. James K.D., Forester S.C., Lambert J.D. Dietary pretreatment with green tea polyphenol, (-)-epigallocatechin-3-gallate reduces the bioavailability and hepatotoxicity of subsequent oral bolus doses of (-)-epigallocatechin-3-gallate. Food Chem. Toxicol. 2014, 76C:103-108.
13. Kao Y.H., Hiipakka R.A., Liao S. Modulation of endocrine systems and food intake by green tea epigallocatechin gallate. Endocrinology 2000, 141(3):980-987.
14. Kim H.S., Quon M.J., Kim J.A. New insights into the mechanisms of polyphenols beyond antioxidant properties; lessons from the green tea polyphenol, epigallocatechin 3-gallate. Redox Biol. 2014, 2:187-195.
15. Kishimoto Y., Kanahori S., Sakano K., Ebihara S. The maximum single dose of resistant maltodextrin that does not cause diarrhea in humans. J.Nutr. Sci. Vitaminol. (Tokyo) 2013, 59(4):352-357.
16. Lambert J.D., Elias R.J. The antioxidant and pro-oxidant activities of green tea polyphenols: a role in cancer prevention. Arch. Biochem. Biophys. 2010, 501(1):65-72.
17. Lambert J.D., Sang S., Yang C.S. Biotransformation of green tea polyphenols and the biological activities of those metabolites. Mol. Pharm. 2007, 4(6):819-825.
18. Livesey G. Tolerance of low-digestible carbohydrates: a general view. Br. J. Nutr. 2001, 85(Suppl.1):S7-S16.
19. Mazzanti G., Menniti-Ippolito F., Moro P.A., Cassetti F., Raschetti R., Santuccio C., Mastrangelo S. Hepatotoxicity from green tea: a review of the literature and two unpublished cases. Eur. J. Clin. Pharmacol. 2009, 65(4):331-341.
20. Nantz M.P., Rowe C.A., Bukowski J.F., Percival S.S. Standardized capsule of camellia sinensis lowers cardiovascular risk factors in a randomized, double-blind, placebo-controlled study. Nutrition 2009, 25(2):147-154.
21. National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. NCI, NIH, DHHS May 29, 2009, NIH publication #, 09-7473.
22. Navarro V.J., Bonkovsky H.L., Hwang S.I., Vega M., Barnhart H., Serrano J. Catechins in dietary supplements and hepatotoxicity. Dig. Dis. Sci. 2013, 58(9):2682-2690.
23. Oku T., Hongo R., Nakamura S. Suppressive effect of cellulose on osmotic diarrhea caused by maltitol in healthy female subjects. J.Nutr. Sci. Vitaminol. (Tokyo) 2008, 54(4):309-314.
24. Patel S.S., Beer S., Kearney D.L., Phillips G., Carter B.A. Green tea extract: a potential cause of acute liver failure. World J. Gastroenterol. 2013, 19(31):5174-5177.
25. Pratt D.S., Kaplan M.M. Evaluation of abnormal liver-enzyme results in asymptomatic patients. N.Engl. J. Med. 2000, 342(17):1266-1271.
26. Sang S., Lambert J.D., Ho C.T., Yang C.S. The chemistry and biotransformation of tea constituents. Pharmacol. Res. 2011, 64(2):87-99.
27. Sarma D.N., Barrett M.L., Chavez M.L., Gardiner P., Ko R., Mahady G.B., Marles R.J., Pellicore L.S., Giancaspro G.I., Low Dog T. Safety of green tea extracts: a systematic review by the US pharmacopeia. Drug Saf. 2008, 31(6):469-484.
28. Ullmann U., Haller J., Decourt J.D., Girault J., Spitzer V., Weber P. Plasma-kinetic characteristics of purified and isolated green tea catechin epigallocatechin gallate (EGCG) after 10 days repeated dosing in healthy volunteers. Int. J. Vitam. Nutr. Res. 2004, 74(4):269-278.
29. Widlansky M.E., Hamburg N.M., Anter E., Holbrook M., Kahn D.F., Elliott J.G., Keaney J.F., Vita J.A. Acute EGCG supplementation reverses endothelial dysfunction in patients with coronary artery disease. J.Am. Coll. Nutr. 2007, 26(2):95-102.
30. Wu A.H., Tseng C.C., Van Den Berg D., Yu M.C. Tea intake, COMT genotype, and breast cancer in asian-american women. Cancer Res. 2003, 63(21):7526-7529.
31. Yang C.S., Wang H., Li G.X., Yang Z., Guan F., Jin H. Cancer prevention by tea: Evidence from laboratory studies. Pharmacol. Res. 2011, 64(2):113-122.
32. Yang C.S., Chen L., Lee M.J., Balentine D., Kuo M.C., 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. 1998, 7(4):351-354.
33. Yang J., Wang H.P., Zhou L., Xu C.F. Effect of dietary fiber on constipation: a meta analysis. World J. Gastroenterol. 2012, 18(48):7378-7383.
34. Yuan J.M. Cancer prevention by green tea: evidence from epidemiologic studies. Am. J. Clin. Nutr. 2013, 98(6 Suppl.l):1676S-1681S.