Unique ID issued by UMIN | UMIN000051423 |
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Receipt number | R000058659 |
Scientific Title | Effects of consumption of the test food on sleep quality in healthy Japanese menopausal women: a randomized, placebo-controlled, parallel-group comparison study |
Date of disclosure of the study information | 2023/06/23 |
Last modified on | 2023/12/26 18:15:31 |
Effects of consumption of the test food on sleep quality in healthy Japanese menopausal women: a randomized, placebo-controlled, parallel-group comparison study
Effects of consumption of the test food on sleep quality in healthy Japanese menopausal women: a randomized, placebo-controlled, parallel-group comparison study
Effects of consumption of the test food on sleep quality in healthy Japanese menopausal women: a randomized, placebo-controlled, parallel-group comparison study
Effects of consumption of the test food on sleep quality in healthy Japanese menopausal women
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the improving effects of consumption of the test food on sleep quality in healthy Japanese menopausal women
Efficacy
Confirmatory
Pragmatic
Not applicable
1. Zc score ("Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing" and "sleep length") of the OSA sleep inventory MA version (OSA-MA) at 8 weeks after consumption (8w)
2. Each item of the OSA-MA at 8w
3. The simplified menopausal index (SMI) at 8w
4. Each item of the SMI at 8w
5. Estradiol (E2) and follicle stimulating hormone (FSH) at 8w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: Eight weeks
Test food: Capsule containing Maca extract powder
Administration: Take two capsules with water before sleep once a day
* If you forget to take the test food, do not carry it over to the next day.
Duration: Eight weeks
Test food: Placebo capsule
Administration: Take two capsules with water before sleep once a day
* If you forget to take the test food, do not carry it over to the next day.
45 | years-old | <= |
60 | years-old | >= |
Female
1. Japanese
2. Women
3. Subjects aged 45 or more and 60 or less
4. Healthy subjects
5. Subjects who have experienced natural menopause within three years
6. Subjects whose SMI are 26 or more and less than 50
7. Subjects who have relatively low "sleepiness on rising" (Zc score) of the OSA-MA among those meeting 1. ~ 6. of the inclusion 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. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who live with infants less than one year old
8. Subjects who sleep with children (1 to 6 years old)
9. Subjects who live with and need to care for those in requiring long-term care
10. Subjects who sleep with more than one person
11. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift
12. Subjects who have nocturia two times or more
13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
14. Subjects who are judged as ineligible to participate in this study by the physician
52
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
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.
LATINA, Inc.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 06 | Month | 23 | Day |
Unpublished
58
Completed
2023 | Year | 06 | Month | 14 | Day |
2023 | Year | 06 | Month | 14 | Day |
2023 | Year | 06 | Month | 23 | Day |
2023 | Year | 09 | Month | 24 | Day |
2023 | Year | 06 | Month | 23 | Day |
2023 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058659
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