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Nutrients
Volume 15
Issue 2
10.3390/nu15020299
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Article

A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women

by
Nadia Rajaram
1,
Beverley Yap
1,
Mikael Eriksson
2,
Shivaani Mariapun
1,
Lee Mei Tan
1,
Hamizah Sa’at
3,
Evelyn Lai Ming Ho
4,
Nur Aishah Mohd Taib
3,
Geok Lin Khor
5,
Cheng Har Yip
1,6,
Weang Kee Ho
1,7,
Per Hall
2,8 and
Soo Hwang Teo
1,3,*
1
Cancer Research Malaysia, Subang Jaya 47500, Malaysia
2
Karolinska Institutet, 171 77 Stockholm, Sweden
3
University of Malaya Cancer Research Institute, Kuala Lumpur 50603, Malaysia
4
ParkCity Medical Centre, Ramsay Sime Darby Healthcare, Kuala Lumpur 52200, Malaysia
5
Department of Nutrition and Dietetics, Universiti Putra Malaysia, Serdang 43400, Malaysia
6
Subang Jaya Medical Centre, Ramsay Sime Darby Healthcare, Subang Jaya 47500, Malaysia
7
Department of Applied Mathematics, Faculty of Engineering, University of Nottingham Malaysia, Semenyih 43500, Malaysia
8
Södersjukhuset, 118 83 Stockholm, Sweden
*
Author to whom correspondence should be addressed.
Nutrients 2023, 15(2), 299; https://doi.org/10.3390/nu15020299
Submission received: 21 November 2022 / Revised: 19 December 2022 / Accepted: 3 January 2023 / Published: 6 January 2023
(This article belongs to the Special Issue Dietary Interventions and Women’s Health)
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Abstract

Soy intake is associated with lower breast cancer risk in observational studies concerning Asian women, however, no randomized controlled trials (RCT) have been conducted among Asian women living in Asia. This three-armed RCT assessed the effects of one-year soy isoflavone (ISF) intervention on mammographic density (MD) change among healthy peri- and postmenopausal Malaysian women. This study was registered at ClinicalTrials.gov (NCT03686098). Participants were randomized into the 100 mg/day ISF Supplement, 50 mg/day ISF Diet, or control arm, and assessed for change in absolute and relative dense area from digital mammograms conducted at enrolment and after 12 months, compared over time across study arms using Kruskal-Wallis tests. Out of 118 women enrolled, 91 women completed the intervention, while 27 women (23%) were lost in follow up. The ISF supplement arm participants observed a larger decline in dense area (−1.3 cm2), compared to the ISF diet (−0.5 cm2) and control arm (−0.8 cm2), though it was not statistically significant (p = 0.48). Notably, among women enrolled within 5 years of menopause; dense area declined by 6 cm2 in the ISF supplement arm, compared to <1.0 cm2 in the control arm (p = 0.13). This RCT demonstrates a possible causal association between soy ISF intake and MD, a biomarker of breast cancer risk, among Asian women around the time of menopause, but these findings require confirmation in a larger trial.
Keywords: Soy isoflavones; mammographic density; randomized controlled trial; breast cancer Soy isoflavones; mammographic density; randomized controlled trial; breast cancer

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MDPI and ACS Style

Rajaram, N.; Yap, B.; Eriksson, M.; Mariapun, S.; Tan, L.M.; Sa’at, H.; Ho, E.L.M.; Taib, N.A.M.; Khor, G.L.; Yip, C.H.; et al. A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women. Nutrients 2023, 15, 299. https://doi.org/10.3390/nu15020299

AMA Style

Rajaram N, Yap B, Eriksson M, Mariapun S, Tan LM, Sa’at H, Ho ELM, Taib NAM, Khor GL, Yip CH, et al. A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women. Nutrients. 2023; 15(2):299. https://doi.org/10.3390/nu15020299

Chicago/Turabian Style

Rajaram, Nadia, Beverley Yap, Mikael Eriksson, Shivaani Mariapun, Lee Mei Tan, Hamizah Sa’at, Evelyn Lai Ming Ho, Nur Aishah Mohd Taib, Geok Lin Khor, Cheng Har Yip, and et al. 2023. "A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women" Nutrients 15, no. 2: 299. https://doi.org/10.3390/nu15020299

APA Style

Rajaram, N., Yap, B., Eriksson, M., Mariapun, S., Tan, L. M., Sa’at, H., Ho, E. L. M., Taib, N. A. M., Khor, G. L., Yip, C. H., Ho, W. K., Hall, P., & Teo, S. H. (2023). A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women. Nutrients, 15(2), 299. https://doi.org/10.3390/nu15020299

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