2.1. Study Participants
RECRUITMENT
The Malaysian Soy and Mammographic Density (MiSo) Study is a three-armed, randomized controlled trial with no blinding and no placebo control. Peri- and postmenopausal Malaysian women between 45 and 65 years old were invited to participate in the trial between November 2018 and December 2019 at a private tertiary hospital in Malaysia (Subang Jaya Medical Centre). Participants were recruited from an established research database of women attending mammography screening at Subang Jaya Medical Centre and University Malaya Medical Centre, as well as by opportunistic recruitment via social media. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol and source documents were approved by the Ramsay Sime Darby Independent Ethics Committee (Reference number: 201805.1), and the study is registered with the Malaysian National Medical Research Register (NMRR-18-287-40385) and ClinicalTrials.gov (NCT03686098). All participants signed the informed consent form prior to any study procedures.A total of 177 women signed the informed consent form and were screened for eligibility (