Unique ID issued by UMIN | UMIN000030087 |
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Receipt number | R000034350 |
Scientific Title | Examination on the action of botanical extracts on brain functions |
Date of disclosure of the study information | 2017/11/22 |
Last modified on | 2018/04/18 13:17:13 |
Examination on the action of botanical extracts on brain functions
Examination on the action of botanical extracts on brain functions
Examination on the action of botanical extracts on brain functions
Examination on the action of botanical extracts on brain functions
Japan |
Healthy adult
Adult |
Others
NO
To examine an influence of a test food product on brain functions by selecting healthy males and females of Japanese nationality aged 50 and over, below 70 as subjects and assigning them to take the test food product for 12 weeks on a continuous basis.
Efficacy
Improvement effects of Cognitrax on brain functions
Blood concentration of BDNF, blood concentration of inflammatory cytokines(TNF-,IL-6,IL-1),
BAP levels and d-ROMs in blood, urinary 8-0HdG, and isoprostane in urine
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
4-week intake of the test food
4-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)Persons who are aware of a decline in cognitive functions
1)Currently in treatment with medication or currently seeing a doctor for treatment
2)Previous history of hepatic disorder, severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these.
3)Previous history of drug allergy or food allergy
4)Current intake of a health food product or supplements with a possible influence on the cognitive functions
5)Current administration of medication with a possible influence on the cognitive functions
6)Extreme faddiness
7)Extremely irregular lifestyle habits such as eating and sleeping habits
8)Suspected insomnia
9)Presence or previous history of mental disorder (depression, etc.)
10)Presence or previous history of alcoholism
11)Current participation in any other clinical study or participation in other clinical study in the past three months
12)Night shifts or irregular work schedule
13)Determined by the investigator to be unsuitable for enrollment in this study
60
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
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
Ezaki Glico Co., Ltd.
Profit organization
NO
2017 | Year | 11 | Month | 22 | Day |
Unpublished
Completed
2017 | Year | 10 | Month | 13 | Day |
2017 | Year | 11 | Month | 20 | Day |
2018 | Year | 02 | Month | 23 | Day |
2017 | Year | 11 | Month | 22 | Day |
2018 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034350
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