Healthy subjects
Conditions
Interventions
Intake the test food, and take wash out period for 1 week, then intake the placebo food
Intake the placebo food, and take wash out period for 1 week, then intake the test food
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males who have a drinking habit, aged 20-59 years old 2. Subjects estimated that genotypes is NN or ND type in alcohol patch test 3. Subjects who can drink alcohol effortlessly
Exclusion criteria
Exclusion criteria: 1. Subjects who constantly use supplements including Functional substances 2. Subjects estimated no to be able to drink alcohol by patch test etc. 3. Subjects who constantly use supplements or drug affecting the liver function 4. Subjects with chronic illness or medication 5. Subjects with easy-to-GI disease (particularly alcohol easy to be diarrhea) 6. Subjects who has oral trouble 7. Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease 8. Subjects with allergies to the test food or alcohol in the study 9. Subjects with excessive smoking 10. Subjects who drink alcohol a lot 11. Subjects who work at night or have irregular life more than one time in the study 12. Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies 13. Subject who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements 14. Subjects who are judged as unsuitable for the study from questionnaire 15. Subjects who are judged as ineligible by clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood alcohol curve | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak in blood alcohol concentration, breath alcohol concentration, area under the breath alcohol curve, blood alcohol concentration and breath alcohol concentration at 30, 60, 90, 120, and 180 min after alcohol ingestion, and questionnaire survey | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed