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SECOND INTERNATIONAL SYMPOSIUM
ON THE ROLE OF SOY
IN PREVENTING AND TREATING CHRONIC DISEASESeptember 15-18, 1996
Brussells, Belgium
POSTER ABSTRACTSA randomized trial to prevent hormonal patterns at high risk for breast cancer: the DIANA (Diet and Androgens) project.
Berrino F., Secreto G., Camerini E., Bellati C., Maffei F., Pala V., Allegro G., Venturelli E., Cavalleri A., Rinaldi S., Oldani S., Fissi R., Campa T., Magni A., Kaaks R.*, Catania S.**, Gastaldi S.*** , Ricciuti A.*** and Burrone A.***
Istituto Nazionale Tumori, Via Venezian 1, Milan, Italy;
*International Agency for Research on Cancer,150 Cours A. Thomas Lyon, France; **Ospedale San Donato Milanese, Milan, Italy; ***Association "Attivecomeprima", Via Livigno 3, Milan, Italy;
Recent prospective studies with biological banking have proven beyond reasonable doubt that post-menopausal breast cancer is preceded by high serum levels of sex steroid hormones, both androgens and estrogens, expecially of their bioavailable fraction, i.e. the fraction not linked to the sex hormone binding globulin (SHBG) (Toniolo et al, JNCI 1995; Berrino et al, JNCI 1996; Dorgan et al, Cancer Epidemiol Biomarkers Prev, 1966). Several in vitro and in vivo studies have suggested that both sex hormone levels and breast cancer risk can be reduced through dietary manipulation (Adlercreutz, Scand J Clin Lab Invest, 1990; Messina et al, Nutr Cancer, 1994). We have hypothesized that a comprehensive modification of western diet for the prevention of breast cancer should include:
1) phytoestrogen rich foods, such as traditional soyfoods, other legumes, flaxseed, whole cereals, seaweeds, various seeds, berries and nuts and cruciferous vegetables, which may stimulate SHBG synthesis and modify sex hormones metabolism; 2) low glycemic index food, such as unrefined cereals and legumes, in order to decrease insulin level, which inhibits SHBG synthesis and may stimulate androgen production; 3) factors enhancing insulin sensitivity, such as omega-3 fatty acids, vegetable fibers, vitamin B6, chromium; and 4) less animal fat (except omega-3) and refined carbohydrates in order to reduce body fat and waist to hip ratio, associated with high sex hormones and low SHBG levels.
We have carried out a randomized trial on 104 voluntary post-menopausal healthy women, aged 50 to 65, living in Milan (Northern Italy), at high risk of breast cancer because of high serum testosterone level (above the upper tertile of the distribution) 52 of them were randomized to follow for 4.5 months the diet outlined above, based on mediterranean and macrobiotic recipes, without any recommendation to reduce total food intake, and 52 to follow their usual diet. Compliance with the protocol was 98%. Fasting blood was collected at baseline and after 2 and 4.5 months of intervention and serum was preserved at -80(inf)C to be analyzed for hormones in the same RIA assays.
Serum testosterone decreased significantly in the diet group (-18,3%) compared to the control group (-7.0%, P=0.006), and SHBG increased (23.4% versus 4.1%, P=0.000). Dietary intervention also significantly decreased total cholesterol (-13.6% versus -4.6% among controls), body weight (-4 kg versus -0.6 kg) and waist circumference (-3.8 versus -0.4 cm). Other hormonal assays are being carried out.
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