Unique ID issued by UMIN | UMIN000049004 |
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Receipt number | R000055824 |
Scientific Title | A verification study of the prevention of frailty: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/09/22 |
Last modified on | 2024/02/15 18:01:11 |
A verification study of the prevention of frailty
A verification study of the prevention of frailty
A verification study of the prevention of frailty: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the prevention of frailty
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on frailty
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Physical characteristic check up
Cognitive function tests
QoL questionnaire
Blood markers test
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
Duration: 12 weeks
Take test food with water or hot water.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Take placebo food with water or hot water.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
60 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 60 or more
4. Healthy subjects
5. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
6. Subjects whose gait speed is relatively low
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 consciously take dietary fiber and oligosaccharides
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who have an exercise habit of two times or more per week and 30 minutes or more each time, and been doing it for one year or more
9. Subjects who suffer from COVID-19
10. 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
11. Subjects who are judged as ineligible to participate in this study by the physician
60
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.
Taiyo Kagaku Co. Ltd.
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 Building, 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)
2022 | Year | 09 | Month | 22 | Day |
Unpublished
66
Completed
2022 | Year | 09 | Month | 14 | Day |
2022 | Year | 09 | Month | 14 | Day |
2022 | Year | 09 | Month | 22 | Day |
2023 | Year | 03 | Month | 25 | Day |
2022 | Year | 09 | Month | 22 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055824
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