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Effects of consumption of the test food on perimenstrual symptoms in healthy female college students

Effects of consumption of the test food on perimenstrual symptoms in healthy female college students: a double-blind, placebo-controlled, crossover comparison trial - Effects of consumption of the test food on perimenstrual symptoms in healthy female college students

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054186
Enrollment
30
Registered
2025-12-16
Start date
2024-05-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Daily intake of test food for 2 menstrual cycles -&gt
Washout for 1 menstrual cycle -&gt
Daily intake of placebo food for 2 menstrual cycles Daily intake of placebo food for 2 menstrual cycles -&gt
Daily intake of test food for 2 menstrual cycles

Sponsors

Otsuma Women's University
Lead Sponsor
Naoko Ishiwata (Department of Life Environments Management, Atomi University)
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Subjects who are healthy female students aged 18 or more 2) Subjects who have any physical or psychological symptoms during pre-menstruation 3) Subjects who are receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects who are allergic to the test food 2) Subjects who are having serious disorders 3) Subjects who are undergoing medical treatment of gynecological such as premenstrual symptoms and premenstrual dysphoric disorder, or mental diseases 4) Subjects who are constantly taking medicines for gynecological diseases such as low dose pill and herbal medicines 5) Subjects who are constantly taking supplements that attenuating premenstrual symptoms 6) Subjects who are pregnant or lactating, or intending to become pregnant during the study 7) Subjects whose menstrual cycle is not within the range of 25 to 38 days 8) Subjects who are currently taking part in another clinical studies 9) Subjects who are judged as ineligible to participate in this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Perimenstrual symptoms questionnaire

Secondary

MeasureTime frame
Basal body temperature

Countries

Japan

Contacts

Public ContactChisato Aiso

Fujicco Co., Ltd. Innovation center

c-aiso@fujicco.co.jp078-303-5385

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026