Unique ID issued by UMIN | UMIN000037725 |
---|---|
Receipt number | R000043003 |
Scientific Title | Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment |
Date of disclosure of the study information | 2019/08/23 |
Last modified on | 2020/03/27 09:10:34 |
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Japan |
Healthy subjects
Adult |
Others
NO
The objective of this study is to examine effect to give improvement of the higher brain function in healthy Japanese men and women aged less than 50 years or older 80 years old with suspected mild cognitive impairment who have continued to consume the test food for 16 weeks.
Efficacy
RBANS
MCI screen
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
Central registration
2
Prevention
Food |
16-week intake of the test food
16-week intake of the placebo food
50 | years-old | <= |
80 | years-old | > |
Male and Female
1)Japanese male and female aged less than 50 years or older 80 years old at the time of the informed.
2)Male and female with Japanese nationality.
3)Subject with an MMSE score of 22 or more.
4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
1)Subject who is diagnosed as dementia.
2)Subject who is under exercise therapy or dietetic therapy.
3)Subject who has an allergy for test food.
4)Subject who has or had a history of either medicine or alcohol dependence syndrome.
5)Subject who has or had a history of mental illness (depression) or sleep disturbance.
6)Subject who is on a night-shift or is a shift worker.
7)Subject whose lifestyle is extremely irregular.
8)Subject who has an unbalanced diet.
9)ubjects who have disease or history of diabetes, liver disease(hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, and metabolic disease.
10)Subject who uses health foods, supplements, and medicines that may affect cognitive function
11)Subjects who has undergone surgery of the gastrointestinal tract(Appendicitis is excluded).
12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
14Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15)Subject who can't keep the daily records.
16)Subject who is judged as an inappropriate candidate according to the screening data.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.
80
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
Morinaga Milk Industy Co, Ltd.
Profit organization
Ethics Committees of Nihonbashi Egawa Clinic
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
03-5204-0311
jim@medipharma.co.jp
NO
2019 | Year | 08 | Month | 23 | Day |
Unpublished
80
Completed
2019 | Year | 05 | Month | 20 | Day |
2019 | Year | 06 | Month | 17 | Day |
2019 | Year | 08 | Month | 09 | Day |
2019 | Year | 12 | Month | 24 | Day |
2019 | Year | 12 | Month | 24 | Day |
2020 | Year | 01 | Month | 22 | Day |
2020 | Year | 03 | Month | 26 | Day |
2019 | Year | 08 | Month | 19 | Day |
2020 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043003
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |