Unique ID issued by UMIN | UMIN000037121 |
---|---|
Receipt number | R000042300 |
Scientific Title | 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 |
Date of disclosure of the study information | 2019/06/20 |
Last modified on | 2022/04/06 10:03:47 |
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
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
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of the test food on psychological stress and other subjective symptoms on the healthy Japanese women aged 30 or over to under 70
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
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.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
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 you remember within the day.
Duration: 12 weeks
Test food: Placebo tablets
Administration: Take three tablets per day after breakfast with water
* If you forget to take the test food, take it as soon as you remember within the day.
30 | years-old | <= |
70 | years-old | > |
Female
1. Healthy subjects
2. Japanese women aged >=30 to <70
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
60
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
INTERTRADE Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2019 | Year | 06 | Month | 20 | Day |
Unpublished
66
Completed
2019 | Year | 06 | Month | 10 | Day |
2019 | Year | 06 | Month | 10 | Day |
2019 | Year | 06 | Month | 21 | Day |
2020 | Year | 02 | Month | 22 | Day |
2019 | Year | 06 | Month | 20 | Day |
2022 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042300
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