Tokyo, Jan. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060040) titled 'Evaluation of the Effect of Test Food Consumption on Premenstrual Symptoms' on Jan. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - KAGOME CO., LTD.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To conduct an exploratory evaluation of the effects of consuming the test food on premenstrual symptoms.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - From day 5 of the first menstrual cycle (cycle 0) until 7 days after the end of the third menstrual cycle, participants will take the test food (two capsules) once daily with water.
Interventions/Control_2 - From day 5 of the first menstrual cycle (cycle 0) until 7 days after the end of the third menstrual cycle, participants will take the placebo food (two capsules) once daily with water.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Age between 20 years and under 40 years at the time of obtaining consent
2. Healthy Japanese women
3. Regular menstrual cycles and normal menstrual duration
(Reference ranges: menstrual cycle of 25-38 days and menstrual duration of 3-7 days)
4. Presence of subjective premenstrual symptoms
5. Individuals who have received sufficient explanation regarding the purpose and content of this study, have the capacity to consent, fully understand the information, voluntarily agree to participate, and provide their own consent through electronic informed consent
Key exclusion criteria - 1. Individuals diagnosed with any disease or receiving treatment, preventive care, or medication (including herbal medicine), hormone replacement therapy, or scheduled to receive such treatment
2. Individuals with a history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disorders
3. Individuals with a history of severe gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection; appendectomy only allowed)
4. Individuals judged to have a possible mental disorder based on SDS scores in Web-SCR
5. Individuals with a low premenstrual score on MDQ Form C (excluding the mood elevation item) in the Web-SCR
6. Individuals with a history of discomfort or health deterioration due to blood sampling
7. Individuals with food allergies
8. Individuals who have donated 200 mL of whole blood within 4 weeks, component blood within 2 weeks, or 400 mL of whole blood within 16 weeks prior to the Web-SCR
9. Individuals with significant abnormalities in blood, urine, or physical examinations
10. Individuals unable to discontinue quasi-drugs, herbal medicines, foods for specified health uses, functional foods, health foods, or foods containing herbs, lactic acid bacteria, or bifidobacteria during the study
11. Current smoker
12. Individuals who habitually consume alcohol (approximately 60 g or more per day)
13. Individuals with extremely irregular sleep or eating habits (e.g., shift workers)
14. Individuals likely to experience major changes in living environment, diet, or exercise habits during the study
15. Individuals who are breastfeeding, pregnant, possibly pregnant, or intending to become pregnant during the study
16. Individuals currently participating in another clinical study, who participated within 4 weeks before Web-SCR, or who plan to participate during the study
17. Individuals judged unsuitable by the principal investigator
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 10 Day
Date of IRB - 2025 Year 12 Month 08 Day
Anticipated trial start date - 2026 Year 01 Month 07 Day
Last follow-up date - 2026 Year 10 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068660
Disclaimer: Curated by HT Syndication.
