Co-Administration of Soy Isoflavones and Vitamin D in Management of Irritable Bowel Disease

Mahsa Jalili, Azita Hekmatdoost, Homayoon Vahedi, Hossein Poustchi, Behnam Khademi, Mohsen Saadi, Maryam Zemestani, Leila Janani, Mahsa Jalili, Azita Hekmatdoost, Homayoon Vahedi, Hossein Poustchi, Behnam Khademi, Mohsen Saadi, Maryam Zemestani, Leila Janani

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.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow Diagram of the study.
Fig 1. Flow Diagram of the study.
Fig 2. The effects of soy isoflavones…
Fig 2. The effects of soy isoflavones and/or vitamin D supplementation on abdominal pain severity after 6 weeks; results are adjusted for the baseline values and IBS subtype.
S+P: soy isoflavones and placebo of vitamin D group, S+D: soy isoflavones and vitamin D group, P+P: placebo of soy isoflavones and placebo of vitamin D group, D+P: vitamin D and placebo of soy isoflavones group.* pso of v.
Fig 3. The effects of soy isoflavones…
Fig 3. The effects of soy isoflavones and/or vitamin D supplementation on abdominal pain duration after 6 weeks; results are adjusted for the baseline values and IBS subtype.
S+P: soy isoflavones and placebo of vitamin D group, S+D: soy isoflavones and vitamin D group, P+P: placebo of soy isoflavones and placebo of vitamin D group, D+P: vitamin D and placebo of soy isoflavones group.* pso of v.
Fig 4. The effects of soy isoflavones…
Fig 4. The effects of soy isoflavones and/or vitamin D supplementation on abdominal distension after 6 weeks; results are adjusted for the baseline values and IBS subtype.
S+P: soy isoflavones and placebo of vitamin D group, S+D: soy isoflavones and vitamin D group, P+P: placebo of soy isoflavones and placebo of vitamin D group, D+P: vitamin D and placebo of soy isoflavones group.* pso of v.
Fig 5. The effects of soy isoflavones…
Fig 5. The effects of soy isoflavones and/or vitamin D supplementation on satisfaction of bowel habits after 6 weeks; results are adjusted for the baseline values and IBS subtype.
S+P: soy isoflavones and placebo of vitamin D group, S+D: soy isoflavones and vitamin D group, P+P: placebo of soy isoflavones and placebo of vitamin D group, D+P: vitamin D and placebo of soy isoflavones group.* pso of v.
Fig 6. The effects of soy isoflavones…
Fig 6. The effects of soy isoflavones and/or vitamin D supplementation on life disruption after 6 weeks; results are adjusted for the baseline values and IBS subtype.
S+P: soy isoflavones and placebo of vitamin D group, S+D: soy isoflavones and vitamin D group, P+P: placebo of soy isoflavones and placebo of vitamin D group, D+P: vitamin D and placebo of soy isoflavones group.* pso of v

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