Tokyo, April 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061174) titled 'Effect of a single intake of the test food on premenstrual syndrome (PMS) symptoms' on April 7.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill, Inc.

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

Objective: Narrative objectives1 - To investigate the reductive effects of a single intake of the test food on premenstrual syndrome (PMS) symptoms in women with PMS through a randomized, double-blind, placebo-controlled, parallel-group study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Single dose of the test food Interventions/Control_2 - Single dose of the placebo food

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key inclusion criteria - (1)Healthy females aged 20 to 39 years at the time of informed consent. (2)Subjects with a normal menstrual cycle (25 to 38 days) and a normal menstrual period (3 to 7 days). (3)Subjects with subjective symptoms of premenstrual syndrome (PMS). (4)Subjects who have received a full explanation of the study's purpose and content, have the capacity to consent, and have voluntarily provided their own electronic informed consent (eIC) with a full understanding of the study. Key exclusion criteria - (1) Subjects falling under any of the following categories: a) Current heart, liver, or kidney disease (including complications of other diseases). b) History of cardiovascular disease. c) Current diagnosis of diabetes mellitus. d) Allergies to the test food. e) History of serious diseases such as cancer or tuberculosis. f) History of mental illness. (2) Subjects regularly using oral contraceptives (pill), ovulation inhibitors, hormone agents, medications for menstrual symptoms, or Chinese herbal medicine at the time of web screening (except for temporary use of OTC pain relievers for menstrual cramps or headaches only during premenstrual or menstrual periods). (3) Subjects taking health foods related to PMS at the time of web screening. (4) Subjects receiving medical treatment or medication for chronic diseases (gynecological, mental, thyroid, autonomic nervous system, or others) at web screening, or planning to do so during the study. (5) Subjects who are pregnant (including possible pregnancy), breastfeeding, or planning to become pregnant during the study. (6) Subjects diagnosed with PMDD by the investigator based on the PMDD assessment scale during web screening. (7) Subjects unable to stop consuming FOSHU (Food for Specified Health Uses), Foods with Function Claims, or other health supplements. (8) Subjects unable to stop consuming energy drinks. (9) Current smokers. (10) Subjects with an average daily alcohol intake exceeding 60g (pure alcohol equivalent). (11) Subjects with extremely irregular dietary habits. (12) Shift workers or night-shift workers. (13) Subjects whose living environment, dietary habits, or exercise habits may significantly change during the study. (14) Subjects currently participating in another study, or within 4 weeks of completing one, or planning to participate in another study during this period. (15) Subjects otherwise deemed ineligible by the investigator or sub-investigator. Target Size - 72

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 02 Day Date of IRB - 2026 Year 04 Month 02 Day Anticipated trial start date - 2026 Year 04 Month 08 Day Last follow-up date - 2026 Year 08 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069999

Disclaimer: Curated by HT Syndication.