Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000037121
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 66
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are diagnosed with menopausal syndrome 5. Subjects who receive hormonal therapy 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. Currently taking medicines (include herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products, particularly mushroom 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Low Frequency (LF)/High Frequency (HF) ratio * Assess the measured value at screening (before consumption) and at 4 and 12 weeks after consumption and calculate the amount of change.
- Secondary Outcome Measures
Name Time Method 1. LF 2. HF 3. Average heart rate 4. Maximum heart rate 5. Minimum heart rate 6. TP (total power) 7. ccvTP (coefficient of component variance total power) 8. Deviation value of autonomic function 9. Autonomic functional age 10. Salivary cortisol level 11. Serum crosslinked N-telopeptide of type I collagen 12. Blood serotonin level 13. Serum progesterone level 14. Serum estradiol level 15. Urinary deoxypyridinoline (DPD) 16. Simplified Menopausal Index (SMI) 16-1. SMI 16-2. Each question 17. Profile of Mood States 2nd Edition (POMS2) Japanese version 17-1. Each item of the mood symptoms 17-2. Each question 18. Questionnaire (the Likert scale) * 1-18 Assess the measured value at screening (before consumption) and at 4 and 12 weeks after consumption and calculate the amount of change.