Unique ID issued by UMIN | UMIN000049754 |
---|---|
Receipt number | R000056668 |
Scientific Title | A verification study of the improving effects of the test food consumption on cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/12/12 |
Last modified on | 2024/02/15 18:01:54 |
A verification study of the improving effects of the test food consumption on cognitive function
A verification study of the improving effects of the test food consumption on cognitive function
A verification study of the improving effects of the test food consumption on cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the improving effects of the test food consumption on cognitive function
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the improving effects of the test food consumption for 12 weeks on cognitive function
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The standardized score of composite memory at 12 weeks after consumption (12w)
1. The standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} and each score of a self-administered dementia checklist (SDC) (total score, the score of "subjective cognitive decline," and the score of "subjective decline in daily living functioning") at 12w
2. All items of a SDC at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
Duration: 12 weeks
Test food: SAKURA-KOAMI POWDER capsule
Administration: Take three capsules per day at any time during the day
*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
Test food: Placebo capsule
Administration: Take three capsules per day at any time during the day
*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.
40 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 40 or more
4. Healthy subjects
5. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
6. Subjects whose the standardized score of composite memory measured by Cognitrax are relatively low
7. Subjects who are judged as eligible to participate in the study by the physician
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 have dementia
5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
6. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
7. Subjects who are currently taking medications (including herbal medicines) and supplements
8. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily
9. Subjects who are allergic to medicines and/or the test food related products
10. Subjects who take blue-backed fish such as sardines, mackerel, and saury at least four times a week
11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
12. Subjects who suffer from COVID-19
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.
KOKUYO Co.,Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Department of Life & Health Sciences Teikyo University of Science
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 | 12 | Month | 12 | Day |
Unpublished
56
Completed
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 12 | Month | 12 | Day |
2023 | Year | 06 | Month | 29 | Day |
2022 | Year | 12 | Month | 12 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056668
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