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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Up to 400 mg indole-3-carbinol per day (Laidlaw et al. 2010; Naik et al. 2006; Reed et al. 2005; McAlindon et al. 2001; Bell et al. 2000; Wong et al. 1997; Bradlow et al. 1994).
200 ≥ 400 mg indole-3-carbinol per day (Laidlaw et al. 2010; Naik et al. 2006; Reed et al. 2005; McAlindon et al. 2001; Bell et al. 2000; Wong et al. 1997; Bradlow et al. 1994).
Note: Specific symptoms of low estrogen are not always applicable and should be chosen based on intended subpopulation. As an example, for a male subpopulation, symptoms, such as hot flashes, night sweats, vaginal dryness and irregular menstruations, are not applicable.
To exclude the diagnosis of a serious cause of hormonal imbalance, consult a health care practitioner prior to use (UpToDate 2014).
If you are pregnant or breastfeeding, do not use this product (Reed et al. 2006, Michnovicz et al. 1997).
No statement required.
Must be chosen from the current Natural and Non-prescription Health Products Directorate Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Keep in a cool, dry place, protected from light (Zeligs 2001).
Bell MC, Crowley-Nowick P, Bradlow HL, Sepkovic DW, Schmidt-Grimminger D, Howell P, Mayeaux EJ, Tucker A, Turbat-Herrea EA, Mathis JM. Placebo-Controlled Trial of Indole-3-Carbinol in the Treatment of CIN. Gynecological Oncology 2000;78:123-9.
Bennetts LE, De Iuliis GN, Nixon B, Kime M, Zelski K, McVicar CM, Lewis SE, Aitken RJ. Impact of estrogenic compounds on DNA integrity in human spermatozoa: evidence for cross-linking and redox cycling activities. Mutation Research 2008;641(1-2):1-11.
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Bradlow HL, Michnovicz JJ, Halper M, Miller DG, Wong GY, Osborne MP. Long-term responses of women to indole-3-carbinol or a high fiber diet. Cancer Epidemiology, Biomarkers and Prevention 1994;3(7):591-5.
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Dalessandri KM, Firestone GL, Fitch MD, Bradlow HL, Bjeldanes LF. Pilot study: effect of 3,3'- diindolylmethane supplements on urinary hormone metabolites in postmenopausal women with a history of early-stage breast cancer. Nutrition and Cancer 2004;50:161-7.
Fowke JH, Morrow JD, Motley S, Bostick RM, Ness RM. Brassica vegetable consumption reduces urinary F2-isoprostane levels independent of micronutrient intake. Carcinogenesis 2006;27(10):2096-2102.
Herraiz T, Galisteo J. Endogenous and dietary indoles: a class of antioxidants and radical scavengers in the ABTS assay. Free Radical Research 2004;38(3):323-331.
Jongen, WMF. Glucosinates in Brassica: Occurrence and significance as cancer-modulating agents. Proceedings of the Nutrition Society 1996;55(1B):433-446.
Kwon, C.S., Grose, K.R., Riby, J., Chen, Y.H. & Bjeldanes, L.F. In vivo production and enzyme inducing activity of indolo[3,2-b]carbazole. Journal of Agricultural and Food Chemistry 1994;42(11):2536-2540.
Laidlaw M, Cockerline CA, Sepkovic DW. Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial. Breast Cancer 2010;4:85-95.
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McAlindon TE, Gulin J, Chen T, Klug T, Lahita R, Nuite M. Indole-3-carbinol in women with SLEL: effect on estrogen metabolism and disease activity. Lupus 2001;10(11):779-83.
Michnovicz JJ, Adlercreutz H, Bradlow JL.1997. Changes in Levels of Urinary Estrogen Metabolites After Oral Indole-3-Carbinol Treatment in Humans. Journal of the National Cancer Institute 1997; Vol. 89, Mo. 10.
Naik R, Nixon S, Lopes A, Godfrey K, Hatem MH, Monaghan JM. A randomized phase II trials of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia. International Journal of Gynecological Cancer 2006;16(2):786-90.
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Reed GA, Arneson DW, Putnam WC, Smith HJ, Gray JC, Sullivan DK, Mayo MS, Crowell JA, Hurwitz A. Single-dose and multiple-dose administration of indole-3-carbinol to women: pharmacokinetics based on 3,3'-diindolylmethane. Cancer Epidemiology, Biomarkers and Prevention 2006;15(12):2477-81.
Reed GA, Peterson KS, Smith HJ, Gray JC, Sullivan DK, Mayo MS, Crowell JA, Hurwitz A. A phase I study of indole-3-carbinol in women: tolerability and effects. Cancer Epidemiology, Biomarkers and Prevention 2005;14(8):1953-60.
UpToDate 2014. Diagnostic evaluation of polycystic ovary syndrome in adolescents. [Internet] [Accessed 2014 September 30].
Wong GY, Bradlow L, Sepkovic D, Mehl S, Mailman J, Osborne M. Dose-ranging study of indole-3-carbinol for breast cancer prevention. Journal of Cellular Biochemistry Supplement 1997;28-29:111-6.
Zeligs MA. 2001. The Cruciferous Choice: Diindolylmethane or I3C?. [Internet]. Phytonutrient Supplements for Cancer Prevention and Health Promotion. [Accessed 2012 March 12].
Aggarwal BB, Ichikawa H. Molecular targets and anticancer potential of indole-3-carbinol and its derivatives. Cell Cycle 2005;4:1201-1215.
Aggarwal BB, Shishodia S. Molecular targets of dietary agents for prevention and therapy of cancer. Biochemical Pharmacology 2006;71:1397-1421.
Bradlow HL. Indole-3-carbinol as a chemoprotective agent in breast and prostate cancer. In vivo 2008;22:441-6.
Cavalieri E, Rogan E. Catechol quinones of estrogens in the initiation of breast, prostate, and other human cancers: keynote lecture Estrogens and Cancer. Bradlow HL and Carruba G (eds.). Annals of the New York Academy of Sciences 2006;1089:286-301. Cited In: Bradlow (2008).
Chang YC, Riby J, Chang GH, Peng BC, Firestone G, Bjeldanes LF. Cytostatic and antiestrogenic effectsof 2-(indole-3-ylmethyl)-3,3'-diindolylmethane, a major in vivo product of dietary indole-3-carbinol. Biochemical Pharmacology 1999;58:825-834. [Abstract only]
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Komiyama M, Higuchi K, Noguchi H. Selective synthesis using cyclodextrins as catalysts. Preparation of 3-(hydroxymethyl)indole from indole and formaldehyde. Supramolecular Chemistry 1995;4(4):265-269.
Michnovicz JJ. Increased estrogen 2-hydroxylation in obese women using oral indole-3-carbinol. International Journal of Obesity and Related Metabolic Disorders 1998;22:227-9. [Abstract only]
Minich DM, Bland JS. A Review of the Clinical Efficacy and Safety of Cruciferous Vegetable Phytochemicals Nutrition Reviews 2007;65(6):259-267. [Abstract only]
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Rogan EG. The natural chemopreventive compound indole-3-carbinol: state of the science. In Vivo 2006;20:221-228.
Rosen CA, Bryson PC. Indole-3-carbinol for recurrent respiratory papillomatosis: long-term results. Journal of Voice 2004;18:248-53.
Rosen CA, Woodson GE, Thompson JW, Hengesteg AP, Bradlow HL. Preliminary results of the use of indole-3-carbinol for recurrent respiratory papillomatosis. Otolaryngology - Head and Neck Surgery 1998;118(6):810-5.
Sarkar FH, Li Y. Indole-3-carbinol and prostate cancer. Journal of Nutrition 2004;134:3493S-3498S.
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Yuan Gao-feng, Bo Sun, Jing Yuan, and Qiao-mei Wang. Effects of different cooking methods on health-promoting compounds of broccoli. Journal of Zhejiang University Science B 2009; 10(8):580-588. [Abstract only]