Because soy food consumption may influence breast tissue activity, we examined its effect on the presence of epithelial cells in nipple aspirate fluid (NAF). In a randomized, crossover design, 82 premenopausal women completed a high-soy and a low-soy diet for 6 mo each, separated by a 1-mo washout period. They provided NAF samples at baseline, 6 mo, and 13 mo during the midluteal phase of the menstrual cycle. Papanicolaou-stained cytology slides (for 33 women at baseline, 24 at low-soy, and 36 at high-soy) were evaluated in women with sufficient NAF. Mixed models evaluated the effect of the high-soy diet on epithelial cytology as compared to baseline and the low-soy diet. At the end of the high-soy diet, cytological subclass had decreased in 8 (24%) and increased in 3 (9%) women as compared to baseline, whereas the respective values were 3 (14%) and 6 (29%) for the low-soy diet samples (P = 0.32). Only the change in subclass indicated a trend in lower cytological class (P = 0.06). Contrary to an earlier report, the number of NAF samples with hyperplastic epithelial cells did not increase after a soy intervention in amounts consumed by Asians.
Trial registration: ClinicalTrials.gov NCT00513916.