Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein™ in healthy volunteers

Planta Medica

Volumn 71, Issue 10, 2005, Pages 891-896

  Ullmann, Uwe ^a   Oberwittle, H ^b   Grossmann, M ^b   Riegger, C ^a  

^a DSM NUTRITIONAL PRODUCTS LTD   (Switzerland)

^b Prof Dr Luecker GmbH   (Germany)

Author keywords

Bonistein; Genistein; Multiple dosing; Pharmacokinetics; Safety; Steady state

Indexed keywords

BONISTEIN; GENISTEIN; ISOFLAVONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; FACE EDEMA; FEMALE; HORMONE SUBSTITUTION; HUMAN; HUMAN EXPERIMENT; MALE; NIGHTMARE; NORMAL HUMAN; OSTEOLYSIS; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AREA UNDER CURVE; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENISTEIN; HUMANS; MALE; MIDDLE AGED; PHYTOESTROGENS; PHYTOTHERAPY; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 27844498003     PISSN: 00320943     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2005-864186     Document Type: Article

References (18)

1. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J (Writing Group for the Women's Health Initiative Investigators). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321-33
2. Beral V (Million Women Study Collaborators). Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 19-427
3. Adlercreutz H, Mazur W. Phyto-oestrogens and Western diseases. Ann Med 1997; 29: 95-120
4. Andersson JJ, Anthony MS, Cline JM, Washburn SA, Garner SC. Health potential of soy isoflavones for menopausal women. J Public Health Nutr 1999; 2: 489-504
5. Kuiper CG, Lemmen JG, Carlsson B, Corton JC, Safe SH, van der Saag PT, van der Burg B, Gustafsson JA. Interaction of estrogenic chemicals and phytoestrogens with estrogen receptor beta. Endocrinology 1998; 139: 4252-63
6. Suetsugi M, Su L, Karlsberg K, Yuan YC, Chen S. Flavone and isoflavone phytoestrogens are agonists of estrogen-related receptors. Mol Cancer Res 2003; 13: 981-91
7. Morabito N, Crisafulli A, Vergara C, Gaudio A, Lasco A, Frisina N, D'Anna R, Corrado F, Pizzoleo MA, Cincotta M, Altavilla D, Lentile R, Squadrito F. Effects of genistein and hormone-replacement therapy on bone loss in early post-menopausal women: a randomized double-blind placebo-controlled study. J Bone Mineral Res 20002; 10: 1904-10
8. Albertazzi P, Pansini F, Bonaccorsi G, Zanotti L, Forini E, De Aloysio D. The effect of dietary soy supplementation on hot flushes. Obstet Gynecol 1998; 91: 6-11
9. Kreijkamp-Kaspers S, Kok L, Grobbee DE, de Haan EH, Aleman A, Lampe JW, van der Schouw YT. Effect of soy protein containing isoflavones on cognitive function, bone mineral density, and plasma lipids in postmenopausal women: a randomised controlled trial. JAMA 2004; 292: 65-74
10. Setchell KDR, Lydeking-Olsen E. Dietary phytoestrogens and their effect on bone: evidence from in vitro and in vivo, human observational, and dietary intervention studies. Am J Clin Nutr 2003; 78: 593S-609S
11. Messina M, Ho S, Alekel DL. Skeletal benefits of soy isoflavones: a review of the clinical trial and epidemiologic data. Curr Opin Clin Nutr Metab Care 2004; 7: 649-58
12. McClain RM, Wolz E, Davidovich A, Pfannkuch F, Bausch J. Subchronic and chronic safety studies with genistein in dogs. Food and Chemical Toxicology, in press
13. Ullmann U, Metzner J, Frank T, Cohn W, Riegger C. Safety, tolerability and pharmacokinetics of single ascending doses of synthetic Genistein (Bonistein™) in healthy volunteers. Advances Therap, 2005; 22: 65-78
14. ICH 1996 (E6). Guideline for good clinical practice. CPMP/ICH/135/95.
15. Bloedon LT, Jeffcoat AR, Lopaczynski W, Schell MJ, Black TM, Dix KJ, Thomas BF, Albright C, Busby MG, Crowell JA, Zeisel SH. Safety and pharmacokinetics of purified soy isoflavones: single-dose administration to postmenopausal women. Am J Clin Nutr 2002; 76: 1126-1137
16. Busby MG, Jeffcoat AR, Bloedon LT, Koch MA, Black T, Dix KJ, Heizer WD, Thomas BF, Hill JM, Crowell JA, Zeisel SH. Clinical characteristics and pharmacokinetics of purified soy isoflavones: single-dose administration to healthy men. Am J Clin Nutr 2002; 75: 126-36
17. Lydeking-Olsen E, Beck-Jensen JE, Setchell KD, Holm-Jensen T. Soymilk or progesterone for prevention of bone loss - a 2 year randomized, placebo-controlled trial. Eur J Nutr 2004; 43: 246-57
18. Ulmann U, Bendik I, Flühmann B. Bonistein™ (synthetic genistein), a food component in development for a bone-health nutraceutical. J Physiol Pharmacol 2005; 56 (Suppl1): 79-96