Unique ID issued by UMIN | UMIN000029142 |
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Receipt number | R000033318 |
Scientific Title | Examination on an effect of improving cognitive function by intake of a test food product |
Date of disclosure of the study information | 2017/12/20 |
Last modified on | 2018/03/01 08:37:10 |
Examination on an effect of improving cognitive function by intake of a test food product
Examination on an effect of improving cognitive function by intake of a test food product
Examination on an effect of improving cognitive function by intake of a test food product
Examination on an effect of improving cognitive function by intake of a test food product
Japan |
Healthy subjects
Adult |
Others
NO
To examine an influence of a test food product on cognitive function in Japanese males and females aged 50 and over, below 70 who are aware of a decline in the cognitive function, and assign them to take the test food product for 12 weeks on a continuous basis.
Safety,Efficacy
Cognitrax,MMSE
Hematologic test, blood biochemical test, vital signs
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Food |
12-week intake of the test food
12-week intake of the placebo food
50 | years-old | <= |
69 | years-old | >= |
Male and Female
1.Age: 50 and over, below 70
2.Sex: Males and females with Japanese nationality
3.Those who are aware of a decline in cognitive function
4.Those who can take 9 capsules a day for 12 weeks on a continuous basis
5.MMSE score of 22 or higher
6.Non-smoker
1.Currently in treatment with medication or seeing a doctor for treatment
2.Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3.Previous history of drug allergy or food allergy
4.Regular intake of a food product or supplements with a possible influence on cognitive function
5.Regular intake of drug with a possible influence on cognitive function
6.Extreme faddiness
7.Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8.Suspicion of insomnia
9.Presence or previous history of mental disorder (depression, etc.)
10.Presence or previous history of alcoholism
11.Current participation in another clinical trial or participation in another clinical trial within the last three months
12.Irregular work hours such as working on night shift
13.Determined by the investigator to be unsuitable for enrollment in this study
62
1st name | |
Middle name | |
Last name | Takihara Takanobu |
ITO EN, Ltd.
Central Research Institute
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
0548-54-1247
t-takihara@itoen.co.jp
1st name | |
Middle name | |
Last name | Ochitani Daisuke |
HUMA R&D CORP
Clinical Development Division
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
ochitani@huma-c.co.jp
HUMA R&D CORP
ITO EN,LTD.
Profit organization
NO
2017 | Year | 12 | Month | 20 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 12 | Day |
2017 | Year | 09 | Month | 15 | Day |
2017 | Year | 09 | Month | 14 | Day |
2018 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033318
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