Unique ID issued by UMIN | UMIN000051571 |
---|---|
Receipt number | R000058511 |
Scientific Title | A study for validation of effects on brain activity, by test-food intake in a single dose |
Date of disclosure of the study information | 2024/07/18 |
Last modified on | 2023/07/04 14:49:23 |
A study for validation of effects on brain activity, by test-food intake in a single dose
A study for validation of effects on brain activity, by test-food intake in a single dose
A study for validation of effects on brain activity, by test-food intake in a single dose
A study for validation of effects on brain activity, by test-food intake in a single dose
Japan |
Healthy male/female adults
Adult |
Others
NO
To verify some kind of effect in cerebral function by the test-food intake in a single dose
Safety,Efficacy
Cognitrax (symbol-digit coding, stroop, and shifting attention)
1. The Profile of Mood States Second Edition (Japanese short ver.)
2. Psychological questionnaire
3. Heartbeat
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of the test liquid (200 mL) to the subjects within 3 min.
Ingestion of the placebo (200 mL water) to the subjects within 3 min.
20 | years-old | <= |
35 | years-old | > |
Male and Female
(1) Healthy male/female subjects ranging in age from 20 to 34, at informed consent.
(2) Subjects having less than 25.0 kg/m2 of BMI.
(3) Subjects with no smoking (not less than one year).
(4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
(1) Subjects being under some kind of continuous medical treatment, including the study period.
(2) Subjects who have periodically used health-specific / functional/ health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep.
(3) Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements.
(4) Subjects with excessive alcohol intake.
(5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one.
(6) At the moment of informed consent, subjects who are under other clinical tests with some kind of medicine/food, or participated in those within four weeks before this study, or are planning to join those after the consent.
(7) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period.
(8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this study.
(9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(10) Subjects getting excessive exercise every day.
(11) Subjects with a serious symptom of premenstrual syndrome.
(12) Subjects who will be determined as the condition of being over-sensitiveness to cold, judging from the investigator's opinion at informed consent.
(13) Pregnant, possibly pregnant, and lactating women.
(14) Subjects having some kind of drug and/or food allergy.
(15) Subjects who break out in a rash from putting electrodes on the head and chest.
(16) Subjects with an external injury on their right forefinger.
(17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
24
1st name | Fumiko |
Middle name | |
Last name | Nakamura |
CPCC Company Limited
Clinical Support Department
103-0021
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
03-6225-9001
cpcc-contact@cpcc.co.jp
1st name | Masanori |
Middle name | |
Last name | Numa |
CPCC Company Limited
Clinical Planning Department
103-0021
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
03-6225-9001
cpcc-contact@cpcc.co.jp
CPCC Company Limited
Asahi Quality & Innovations, Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
03-6225-9005
IRB@cpcc.co.jp
NO
2024 | Year | 07 | Month | 18 | Day |
Unpublished
Preinitiation
2023 | Year | 06 | Month | 19 | Day |
2023 | Year | 06 | Month | 16 | Day |
2023 | Year | 07 | Month | 18 | Day |
2023 | Year | 08 | Month | 25 | Day |
2023 | Year | 07 | Month | 10 | Day |
2023 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058511
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |