Unique ID issued by UMIN | UMIN000038621 |
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Receipt number | R000043989 |
Scientific Title | Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50 |
Date of disclosure of the study information | 2019/11/19 |
Last modified on | 2020/03/11 13:50:19 |
Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50
Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50
Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50
Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50
Japan |
Healthy subjects
Adult |
Others
NO
The purpose is to search for test foods that act on autonomic nerves for Japanese males aged 20 to under 50.
Efficacy
Electronic pupillometer measurement data
Heart rate sensor measurement data,questionnaire
Interventional
Parallel
Non-randomized
Open -no one is blinded
Placebo
2
Prevention
Food |
Single intake of test food after conducting Uchida-Kraepelin test on the test day
Single intake of test food after conducting Uchida-Kraepelin test on the test day
20 | years-old | <= |
50 | years-old | > |
Male
1.Japanese male aged 20 years or older and younger than 50 years at the time of the informed consent.
2.Subjects without smoking habits
3.Subjects who can take alcohol
4.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
1.Subject with BMI>=25kg/m2
2.Subject who have an onset or history of eye disease(Excludes mild illnesses such as infectious diseases)
3.Person with eyelid droop
4.Subject who have moved or changed their jobs within the last 3 months, separated from their close relatives, etc., and are likely to have great
5.Subject who is taking medication or under medical treatment because of some serious illness.
6.Subject who is under exercise therapy or dietetic therapy.
7.Subject who has an allergy for test food.
8.Subject who has or had a history of either medicine or alcohol dependence syndrome.
9.Subject who has or had a history of mental illness (depression) or sleep disturbance.
10.Subject who is on a night-shift or is a shift worker.
11.Subject whose lifestyle is extremely irregular.
12.Subject who has an unbalanced diet.
13.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person.
14.Subject who uses health foods ,supplements, and medicines that are thought to affect autonomic nerves, sleep, and stress
15.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.
16.Subject who can't keep the daily records.
17.Subject who is considered as an inappropriate candidate by the doctor in charge.
20
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
Asahi Quality & Innovations 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 | 11 | Month | 19 | Day |
Unpublished
23
Completed
2019 | Year | 11 | Month | 08 | Day |
2019 | Year | 11 | Month | 11 | Day |
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 12 | Month | 18 | Day |
2019 | Year | 12 | Month | 19 | Day |
2019 | Year | 12 | Month | 24 | Day |
2020 | Year | 01 | Month | 31 | Day |
2019 | Year | 11 | Month | 19 | Day |
2020 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043989
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