Unique ID issued by UMIN | UMIN000048093 |
---|---|
Receipt number | R000054812 |
Scientific Title | Effect of the test food on walking function. |
Date of disclosure of the study information | 2022/09/01 |
Last modified on | 2022/06/17 16:30:03 |
Effect of the test food on walking function.
Effect of the test food on walking function.
Effect of the test food on walking function.
Effect of the test food on walking function.
Japan |
Healthy subjects
Adult |
Others
NO
The purpose of this study was to investigate the effects of continuous intake of test foods for 2 weeks on walking function of Japanese men and women, aged 20 years and older and aged 60 to 75 years.
Safety,Efficacy
gait, electroencephalography
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
two weeks intake of the test food1
two weeks intake of the test food2
two weeks intake of the test food3
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Japanese men and women aged 20 years and older and aged 60 to 75 years at the time of informed consent
2) Subject who is able to take 9 capsules daily for 2 weeks.
3) Non smoker
4) Subject who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
1) Subject who is currently receiving any medications or outpatient treatment.
2)Subject who is currently doing exercise or diet under the supervision of a doctor
3)Subject who is may develop allergy due to the test food
4)Subject who is drug dependent, present or dependent on alcohol
5) Subject who is history of psychiatry during hospitalization due to mental disorder (depression etc.) or sleep disorder (insomnia, sleep apnea syndrome etc.)
6)Night shift or shift workers
7) Excessively irregular lifestyle such as eating or sleeping
8) Subject who is extreme skipped eating
9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases
10)Subject who is use health foods, supplements, and medicines that may affect cognitive function
11) Subject who is participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
12)Subject who is carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition
13) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period
14)Subject who is difficult to comply with the records of various surveys
15)Subject who is judged to be unsuitable as subject from clinical laboratory test value and measurement value at the time of SCR
16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
60
1st name | Noritaka |
Middle name | |
Last name | Okamura |
Ehime Prefectural University of Health Sciences
Clinical Examination Department
791-2101
543 Takoda, Tobe-Cho, Iyo-Gun, Ehime
089-958-2111
okamu@epu.ac.jp
1st name | Yoshitake |
Middle name | |
Last name | Baba |
ITOEN, LTD.
Central Research Institute
421-0516
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
0548-54-1247
yoshi-baba@itoen.co.jp
ITOEN, LTD.
ITOEN, LTD.
Profit organization
Ethics Committees of Ehime Prefectural University of Health Sciences
543 Takoda, Tobe-Cho, Iyo-Gun, Ehime
089-958-2111
-
NO
2022 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2022 | Year | 06 | Month | 01 | Day |
2022 | Year | 09 | Month | 01 | Day |
2023 | Year | 11 | Month | 30 | Day |
2022 | Year | 06 | Month | 17 | Day |
2022 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054812
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