Study population
gout, allergy, diabetes
GASTROINTESTINAL DISEASES, ALLERGY, GOUT, HYPOTHYROIDISM, DIABETES
A total of 177 women were assessed from December 2018 to October 2020. Women were excluded if they were previously diagnosed with any breast, cardiovascular, inflammatory or gastrointestinal diseases, or if they had gout, diabetes, hypothyroidism, soya allergy or were on hormone replacement therapies. Women who had a high soya intake (at least one serving of soya per day) or had menstruation less than 3 months from the consent date or a mammogram in the past 12 months were also excluded from the study. After exclusions, 118 participants were randomised, using a computer-generated randomisation list generated by the study manager, to either the negative control arm, soya isoflavone supplement arm or dietary soya arm by the study coordinator. A stratified, block randomisation approach was used to account for potential differences in distribution by ethnicity and menopausal status. The randomisation list was filed in the Trial Master File and concealed until interventions were assigned. Due to the nature of the study treatments, all participants, the study manager and the study coordinator were not blinded to treatment allocation.