Novel dietary FemTech based on dietary reference intakes for premenstrual and menstrual disorders: a pilot open-label randomized controlled trial of dietary intervention

Abstract Background We developed novel Optimized Nutri-Dense Meals (Opti meals) for women based on Japanese dietary reference intakes (DRIs). We aimed to determine the effects of Opti meals on premenstrual disorder (PMD). Method This pilot study was an open-label randomized controlled trial. One hundred women aged 20–45 years with PMD were enrolled in the study and randomly divided into two groups: habitual diet and intervention groups. In the intervention group, two meals per day for three menstrual cycles were replaced with Opti meals based on the Japanese DRIs. The Menstrual Distress Questionnaire (MDQ) and the Japanese version of the Daily Records of Severity of Problems Short-Form version (J-DRSP) served as the primary outcome measures. Sleep quality and several saliva and serum parameters were set as secondary outcomes. Result The intervention group had lower MDQ total scores during the premenstrual (median [Q1–Q3]: 42.0 [23.8–64.0] versus 67.0 [44.0–90.5], p < 0.01) and menstrual (34.0 [23.0–53.0] versus 67.0 [35.0–76.5], p < 0.01) phases, as well as lower final J-DRSP total scores (17.25 [13.73–19.90] versus 22.0 [16.60–28.50], p < 0.01) than the habitual diet group. Some significant differences were observed in the sleep quality test; however, no significant differences were found in saliva or serum parameters at the end of the trial. Conclusion Optimal meals based on the Japanese DRI may improve PMD symptoms. Trial registration UMIN000052973, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060324 (3/12/2023).