Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060924) titled 'Effects of test food intake on quality of life (QOL) in healthy middle-aged women' on March 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Pharma Foods International Co., Ltd.

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

Objective: Narrative objectives1 - To investigate the impact of test food intake on improving the quality of life (QOL) among healthy Japanese women aged between 40 and 64 years. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of 100 mg of the test food for 4 weeks Interventions/Control_2 - Intake of 300 mg of the test food for 4 weeks

Eligibility: Age-lower limit - 40 years-old

Gender - Female Key inclusion criteria - 1. Japanese 2. Female aged 40 to 64 years 3. Healthy individuals 4. Individuals with a SMI total score between 26 and 50 5. Individuals who perceive temporary hot flashes Key exclusion criteria - 1. Diagnosed with or suspected of menopausal/climacteric disorder by a physician 2. History or presence of serious diseases (e.g., malignant tumor, heart failure, or myocardial infarction) 3. Use of a pacemaker or implantable cardioverter defibrillator (ICD) 4. History or presence of chronic diseases (e.g., cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia,hypertension, or any other chronic diseases) 5. Habitual use of health foods, dietary supplements (e.g., GABA, equol, or soy isoflavones), or medications (e.g., Kampo medicines such as Keishibukuryogan or Kamishoyosan) that may affect menopausal symptoms 6. Allergic to medicines or ingredients related to the test product 7. BMI = 25.0 kg/m2 8. Heavy drinkers (average pure alcohol intake >= 60 g/day) 9. Excessive caffeine intake ( >= 500 mg/day) 10. Heavy smokers ( >= 20 cigarettes/ day or Brinkman Index >=400) 11. Extremely irregular lifestyle rhythms due to night shifts, shift work, or other reasons 12. Undergoing exercise or alimentary therapy under medical supervision 13. History or presence of drug or alcohol dependence 14. History or presence of psychiatric/sleep disorders (e.g., depression, insomnia, sleep apnea syndrome) 15. Pregnant, lactating, or planning to become pregnant during this study 16. Enrolled in other clinical trials within 28 days prior to consent, or planning to participate in another study 17. Judged ineligible to participate in this study based on measurement values at screening 18. Judged ineligible to participate in this study by the physician Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 19 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 04 Month 16 Day Last follow-up date - 2026 Year 06 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069700

Disclaimer: Curated by HT Syndication.