Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70

Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70: A randomized double-blind placebo-controlled trial - Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037121

Enrollment

Registered

2019-06-20

Start date

2019-06-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Tablets containing sparassis crispa Administration: Take three tablets per day after breakfast with water * If you forget to take the test food, take it as soon as y

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Healthy subjects 2. Japanese women aged >=30 to <70

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026