Clinical Trial: Effects of continuous test beverage intake on menstrual-related symptoms in young women (Japan)

Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061131) titled 'Effects of continuous test beverage intake on menstrual-related symptoms in young women' on April 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyoritsu Women's University

Condition: Condition - Healthy young women with menstrual-related symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of continuous intake of a test beverage during periods aligned with the menstrual cycle on menstrual-related symptoms, compared with a placebo group. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of the test beverage for two menstrual cycles Interventions/Control_2 - Continuous intake of the placebo beverage for two menstrual cycles

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1. Female university students aged 20-29 years 2. Residents of Japan 3. Individuals with a normal menstrual cycle (25-38 days) and menstrual duration of 3-7 days 4. Individuals experiencing discomfort symptoms from approximately 3 days before menstruation to around the third day of menstruation Key exclusion criteria - 1. Individuals with diseases requiring ongoing medical treatment or follow-up 2. Individuals who are currently taking medications on a regular basis, or who start regular medication use during the study period (including hormonal agents and oral contraceptives) 3. Individuals with gynecological diseases (e.g., secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, endometrial cancer, ovarian cancer) 4. Individuals who dislike consuming the test beverage 5. Individuals who consume the test beverage >=5 days per week or >=7 servings per week 6. Individuals who are unable to discontinue the use of health foods (including dietary supplements), foods for specified health uses (FOSHU), foods with nutrient function claims, or foods with function claims during the study period 7. Individuals who are pregnant, breastfeeding, or intending to become pregnant during the study period 8. Individuals deemed unsuitable as study participants based on responses to the background questionnaire (lifestyle questionnaire) 9. Individuals who have participated in another clinical trial within 1 month prior to obtaining informed consent 10. Individuals with a score of 60 or higher on the Self-Rating Depression Scale (SDS) 11. Individuals whose total MDQ score after menstruation is higher than that before or during menstruation in the pre-survey (MDQ) 12. Individuals deemed unsuitable as participants by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 19 Day Date of IRB - 2026 Year 03 Month 30 Day Anticipated trial start date - 2026 Year 04 Month 23 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069950

Disclaimer: Curated by HT Syndication.