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

## TL;DR

This study tested special meals based on dietary guidelines to reduce premenstrual and menstrual symptoms in women, finding significant improvements in symptom severity.

## Contribution

A novel dietary intervention based on Japanese dietary reference intakes was developed and shown to reduce premenstrual and menstrual disorder symptoms.

## Key findings

- Optimized meals reduced premenstrual and menstrual distress scores significantly compared to habitual diets.
- Participants reported better symptom severity scores after following the dietary intervention.
- No significant changes were observed in saliva or serum biomarkers, but sleep quality showed some improvement.

## Abstract

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).

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.

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.

Optimal meals based on the Japanese DRI may improve PMD symptoms.

UMIN000052973, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060324 (3/12/2023).

The online version contains supplementary material available at 10.1186/s12905-026-04382-6.