Unique ID issued by UMIN | UMIN000045720 |
---|---|
Receipt number | R000052195 |
Scientific Title | Relaxation effect confirmation test of test beverage |
Date of disclosure of the study information | 2022/10/11 |
Last modified on | 2022/10/05 15:08:24 |
Relaxation effect confirmation test of test beverage-2
Relaxation effect confirmation test of test beverage-2
Relaxation effect confirmation test of test beverage
Relaxation effect confirmation test of test beverage
Japan |
Healthy subjects
Adult |
Others
NO
The Psychological Impact of Food Ingredients will be examined for Japanese men and women between the ages of 20 and 35.
Safety,Efficacy
Heart rate sensor measurement data
(Secondary outcomes)
Psychological evaluation questionnaire, flavor evaluation questionnaire.
(Safety evaluation)
Vital signs, physical measurements, adverse events.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Take test beverage on the day of the test.
Wash out
Take placebo beverage on the day of the test.
Take placebo beverage on the day of the test.
Wash out
Take test beverage on the day of the test.
20 | years-old | <= |
35 | years-old | > |
Male and Female
1.Japanese male and female who are between 20 and 35 years old at the time of obtaining written consent.
2.Subject with BMI <25kg/m2.
3.Non-smokers (no smoking in the last year)
4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
1.Subject who is taking medication or under medical treatment due to illness.
2.Subject who is taking foods for specified health use, foods with functional claims, health foods (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot stop taking them during the test period.
3.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past.
4.Subject with a history of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc.
5.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin, etc.)
6.Heavy drinker.
7.Subject who has difficulty quitting drinking from the day before the test date.
8.Subject who has extremely irregular eating habits, those who work shifts, those who work late at night, etc.
9.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study.
10.Subject who is likely to be under great stress due to moving, changing jobs, separation from close relatives, etc. within the last 3 months.
11.Subject who exercises violently on a daily basis.
12.Subject with severe PMS (premenstrual syndrome) symptoms.
13.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating.
14.Subject with hay fever or allergic rhinitis (seasonal or perennial)
15.Subject who is allergic to medicines and food.
16.Subject who has or had a history of either medicine or alcohol.
17.Subject who can't keep the daily records.
54
1st name | hidemasa |
Middle name | |
Last name | Toya |
HUMA R&D CORP
Clinical Development Department
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
toya@huma-rd.co.jp
1st name | Hidemasa |
Middle name | |
Last name | Toya |
HUMA R&D CORP
Clinical Development Department
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
toya@huma-rd.co.jp
HUMA R&D CORP
Asahi Quality & Innovations, Ltd
Profit organization
Ethics Committees of Yoga Allergy Clinic
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
03-5491-4478
jim@medipharma.co.jp
NO
2022 | Year | 10 | Month | 11 | Day |
Unpublished
54
Completed
2021 | Year | 09 | Month | 01 | Day |
2021 | Year | 09 | Month | 10 | Day |
2021 | Year | 10 | Month | 12 | Day |
2021 | Year | 11 | Month | 26 | Day |
2021 | Year | 12 | Month | 10 | Day |
2021 | Year | 12 | Month | 14 | Day |
2022 | Year | 10 | Month | 03 | Day |
(Exclusion criteria continued)
18.Subject who is judged as an inappropriate candidate according to the screening data.
19.Subject who the investigator has determined that participation in this study is inappropriate.
2021 | Year | 10 | Month | 11 | Day |
2022 | Year | 10 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052195
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