Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 18.Subject who the investigator has determined that participation in this study is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate sensor measurement data | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Psychological evaluation questionnaire, flavor evaluation questionnaire. (Safety evaluation) Vital signs, physical measurements, adverse events. | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed