Clinical Trial: The effect of intake of food components that affect intestinal and oral factors on menstrual-related complaints in young women - A randomized, single-blind, placebo-controlled, parallel-group comparative study - (Japan)

Tokyo, Sept. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059159) titled 'Examination of the effect of test food intake on menstrual-related symptoms' on Sept. 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Hokkaido University

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

Objective: Narrative objectives1 - The purpose of this study is to explore the possibility that influencing the intestinal and oral environment and nutritional status through food intake may lead to the alleviation and improvement of menstrual-related complaints in young women. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The active food is taken for 10 weeks from the start date of the test food intake Interventions/Control_2 - Subjects will be asked to take a placebo food for 10 weeks from the start date of taking the test food intake

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - Those aged 18 to 24 Those enrolled at the university Person who has menstruation Key exclusion criteria - People with food allergies. Those who cannot stop taking oligosaccharides or lactobacillus / bifidobacterium supplements during the study period. Pregnant women or those who intend to become pregnant during the study period. Those who are participating or planning to participate in other clinical trials during the period from 4 weeks before the pre-test until the end of the intake period. Those who are judged by the investigator to be unsuitable for this study. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 18 Day Date of IRB - 2025 Year 09 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 25 Day Last follow-up date - 2025 Year 12 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067667

Disclaimer: Curated by HT Syndication.