Unique ID issued by UMIN | UMIN000054716 |
---|---|
Receipt number | R000062135 |
Scientific Title | Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects |
Date of disclosure of the study information | 2025/06/20 |
Last modified on | 2024/07/22 10:48:35 |
Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects
Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects
Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects
Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects
Japan |
Male/female adults
Adult |
Others
NO
To investigate the psychological changes induced by single dose consumption of the test food product.
Safety,Efficacy
Psychological Questionnaire
Heart Rate
Interventional
Cross-over
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
2
Prevention
Food |
Consumption of the test food
Consumption of the placebo food
20 | years-old | <= |
35 | years-old | > |
Male and Female
1. Men and women aged 20 to below 35 years at the time of consent acquisition.
2. Subjects with a Body Mass Index (BMI) less than 30.0 kg/m2.
3. Non-smokers (no smoking in the past year).
4. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
1. Subjects unable to adhere to the trial protocol during the study period.
2. Subjects consuming Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period.
3. Subjects taking medications or quasi-drugs that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period.
4. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials at the time of consent acquisition.
5. Subjects who have experienced significant life changes such as moving, changing jobs, or separation from close relatives within the last three months prior to consent acquisition, which could lead to high stress, or those likely to experience such events during the study period.
6. Subjects with irregular life rhythms (including those with highly irregular meal times, shift workers, night workers, etc.).
7. Subjects who engage in excessive physical exercise routinely.
8. Subjects with excessive alcohol intake.
9. Subjects with severe symptoms of Premenstrual Syndrome (PMS).
10. Subjects with a current or past history of drug or alcohol dependence.
11. Subjects with allergic rhinitis that may interfere with trial operations.
12. Subjects under medical supervision for dietary or exercise therapy.
13. Subjects currently receiving treatment for, or with a history of, mental disorders (such as depression) or sleep disorders.
60
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, 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, 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
2025 | Year | 06 | Month | 20 | Day |
Unpublished
60
No longer recruiting
2024 | Year | 05 | Month | 20 | Day |
2024 | Year | 05 | Month | 17 | Day |
2024 | Year | 06 | Month | 21 | Day |
2024 | Year | 08 | Month | 10 | Day |
2024 | Year | 06 | Month | 20 | Day |
2024 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062135