In recent years there has been considerable investigation about the potentials of SOYfoods to reduce the risk of cancer, particularly breast cancer. ISOFLAVONES are compounds with a chemical structure similar to estrogen and can bind to estrogen receptor. The relationship between SOYfoods and breast cancer has become a controversial issue because of concerns -based mostly on some in vitro and rodent data- that ISOFLAVONES may stimulate the growth of existing estrogen-sensitive breast tumors. However, some have indicated that SOY ISOFLAVONES have antitumor and antiproliferative effects. The epidemiologic data are generally consistent with the animal studies, showing no increased risk. In limited clinical studies there is no evidence that isoflavone intake increases tumor growth or proliferation of carcinoma cells. Also, epidemiological studies on breast cancer survival showed that SOY ISOFLAVONES decrease recurrence and mortality of disease. Furthermore, it is demonstrated that in healthy women the pharmacologic dose of estrogen has very low if any risk for breast cancer. Because of the increasing popularity of SOYfoods and the commercial availability of isoflavone supplements and existing concern regarding the estrogen-like effects of ISOFLAVONES in the breast, more clinical research seems to be necessary.

ISOFLAVONES are a group of phytoestrogens found mainly in SOY bean and its products. Their actions on various tissues have motivated researchers to assess the possible related mechanisms and functions. The main objective of this study is to determine the metabolic effects of purified alcohol-extracted SOY protein ISOFLAVONES (SPI) on serum lipoproteins and hormones of mild to moderate hypercho-lesterolemic male subjects. The effects of SPI on this type of patients and on the serum hormone levels have not been evaluated previously. Materials and methods: 30 male volunteers were randomly divided into two groups in a double-blind parallel randomized placebo-controlled trial (n=15). Group 1 received 50mg purified alcohol-extracted SOY ISOFLAVONES solution and group 2 received placebo in a similarly colored solution for an 8-week period. Both groups were matched for age, duration of illness, medications, and diet. Data on other variables of each subject i.e. body mass index, smoking habits, blood pressure, and past medical history were also collected. Results: LDL-, VLDL-, and HDL-cholesterol, Tg and thyroxine, triiodothyronine, FSH, testosterone and fasting blood sugar levels did not change significantly compared to their baseline levels. Total cholesterol decreased by 10 percent, (p=0.055). TSH levels in SPI group showed a significant rise after intervention (p<0.05), remaining, however, within normal range. Conclusion: These results indicate that alcohol-extracted SPI without SOY protein does not affect serum lipid profiles and hormones in hypercholesterolemic men. More trials with larger number of subjects conducted over a longer period of study are needed to confirm these findings.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the common gastrointestinal disorders with unknown etiology. In experimental models, it is proposed that SOY ISOFLAVONES may suppress the clinical and psychological symptoms of IBS by alteration of gut barrier tight junctions.METHODS: We conducted this study to evaluate the effects of SOY ISOFLAVONES on IBS symptoms and patients’ quality of life. In a randomized double blind placebocontrolled clinical trial, 67 patients with IBS were allocated to consume either SOY ISOFLAVONES capsules or a placebo for 6 weeks. The primary outcome was a significant reduction in symptoms severity score and the secondary outcome was a significant improvement in quality of life.RESULTS: 45 participants completed the study. There was no significant changes in mean differences of symptoms severity score between the two groups; however SOY isoflavone supplementation could significantly improve the quality of life scores (p=0.009).CONCLUSION: SOY ISOFLAVONES supplementation could improve the quality of life in patients with IBS; however it did not suppress the symptoms severity in 6 weeks. Further research with a longer duration is needed to determine the sustained clinical efficacy. This study was registered at clinicaltrials.gov as NCT02026518