Tokyo, June 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061811) titled 'A study to verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women' on June 5.

Study Type: Interventional

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

Primary Sponsor: Institute - Tsuno Rice Fine Chemicals Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - One menstrual cycle (two times)

Test 1: Test food (food containing inositol) Test 2: Placebo (food not containing inositol)

Chew and take two tablets per day after the first meal of the day.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. *The intervention sequence is Test 1 to Test 2. *The washout period is at least one menstrual cycle. Interventions/Control_2 - One menstrual cycle (two times)

Test1: Placebo (food not containing inositol) Test2: Test food (food containing inositol)

Chew and take two tablets per day after the first meal of the day.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. *The intervention sequence is Test 1 to Test 2. *The washout period is at least one menstrual cycle.

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1. Japanese

2. Women

3. Individuals aged between 20 and 39

4. Healthy individuals

5. Individuals who have common menstrual complaints

6. Individuals whose past three menstrual cycle have been between 25 and 38 days

7. Individuals whose lasting period of the menstruation is between three and seven days Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are undergoing medical treatment or have a medical history of gynecological disease {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial cancer, or ovarian cancer}

5. Individuals who have severe menstrual pain that cannot be controlled with analgesics

6. Individuals who are undergoing medical treatment or have a medical history of psychiatric disorder

7. Individuals who receive hormonal therapy

8. Individuals who are currently taking low dosage pill (oral contraceptive)

9. Postmenopausal individuals

10. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

11. Individuals who are taking or using medications (including herbal medicines) or supplements

12. Individuals who are allergic to medications and foods related to the test product, particularly those allergic to rice

13. Individuals who are pregnant, lactating, or planning pregnancy during this study

14. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 05 Month 27 Day Anticipated trial start date - 2026 Year 06 Month 05 Day Last follow-up date - 2026 Year 12 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070728

Disclaimer: Curated by HT Syndication.