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

Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000054186) titled 'Effects of consumption of the test food on perimenstrual symptoms in healthy female college students' on Dec. 16.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Otsuma Women's University

Condition: Condition - Healthy Japanese subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on perimenstrual symptoms in healthy female college students Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Daily intake of test food for 2 menstrual cycles -> Washout for 1 menstrual cycle -> Daily intake of placebo food for 2 menstrual cycles Interventions/Control_2 - Daily intake of placebo food for 2 menstrual cycles -> Washout for 1 menstrual cycle -> Daily intake of test food for 2 menstrual cycles

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key 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 Key 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 Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 03 Month 31 Day Date of IRB - 2024 Year 03 Month 29 Day Anticipated trial start date - 2024 Year 05 Month 06 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061877

Disclaimer: Curated by HT Syndication.