Abstract
BACKGROUND AND AIMS: The substantial characteristics of Irritable Bowel Syndrome (IBS) are associated with estrogens in women. Both soy isoflavones and vitamin D can modulate estrogen receptors in the colonic smooth muscles. The aim of this study was to investigate the effects of soy isoflavones, vitamin D and their probable interactions in women with IBS. METHODS: In a factorial blinded randomized clinical trial, 100 women with IBS (age:18-75yr, were randomly assigned in 4 arms to receive either placebo of vitamin D and placebo of soy isoflavones (P+P), or placebo of vitamin D and soy isoflavones (P+S), or vitamin D and placebo of soy isoflavones (D+P), or vitamin D and soy isoflavones (D+S) for 6 weeks. Dosage of soy isoflavone was 2 capsules of 20 mg soy isoflavones per day, and dosage of vitamin D was one pearl of 50'000 IU biweekly. The clinical outcomes were IBS symptoms severity scores (IBS-SSS), disease- specific quality of life (IBS-QOL) and total score (IBS-TS) that evaluated at weeks 0, 6, and 10, and compared to each other. RESULTS: IBS-TS improved significantly in both S+P and D+P groups (p- value = 0.004, 0.015). The interaction effect of soy isoflavones and vitamin D on IBS-TS was significant (p<0.05). The interaction effect of soy isoflavones with vitamin D and the main effect of vitamin D on IBS-SSS were not statistically significant, whereas IBS-SSS decreased significantly in S+P and D+P groups (p-value = 0.001, 0.047 respectively). CONCLUSION: Our results indicate that co-administration of soy isoflavones with vitamin D did not improve the IBS- SSS and IBS- QOL; however, it improved the IBS-TS. TRIAL REGISTRATION: Clinical Trials.gov NCT02026518.