Unique ID issued by UMIN | UMIN000031537 |
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Receipt number | R000036008 |
Scientific Title | A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2018/05/01 12:59:26 |
A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism
A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism
A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism
A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism
Japan |
Healthy subjects
Adult |
Others
NO
To confirm enhancing effect of the clam extract powder in alcohol metabolism.
Safety,Efficacy
Concentration of acetaldehyde in blood at each measurement point, AUC of blood acetaldehyde, Concentration of alcohol in blood at each measurement point, AUC of blood alcohol
Efficacy evaluations : VAS questionnaire, alcohol in expired gas
Safety evaluation : Incidence of side effect and adverse events
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Conducting alcohol loading test after intake 2 capsules of the test-food1. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food2. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the control-food.
Conducting alcohol loading test after intake 2 capsules of the test-food2. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the control-food. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food1.
Conducting alcohol loading test after intake 2 capsules of the control-food. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food1. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food2.
20 | years-old | <= |
Not applicable |
Male
1) Males over aged 20 when informed consent.
2) Subjects who can drink alcohol.
(Include subjects who are weak against alcohol from subjective symptom and subjects who don't have liver dysfunction by doctor's judge.)
3) Subjects who have received enough description of the clinical test, understanding about the clinical test and giving written informed consent.
1) Subjects who can't drink alcohol.
2) Subjects who showed strong positive reaction in patch test of alcohol.
3) Subjects who constantly use medicines suspected to have influence to the results of the clinical test. (Turmeric, shellfish, levers and other hangover supplements etc.)
4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ.
5) Subjects who excessive alcohol intake.
6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
7) Subjects who have previous medical history of drug and/or food allergy.
8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
11) Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
14) Others those have been determined ineligible by principal investigator or sub-investigator.
12
1st name | |
Middle name | |
Last name | Ken-ichi Nagamine |
NICHIREI BIOSCIENCES INC.
Research & Development
1-52-14,Kumegawa-cho, Higashimurayama-shi,Tokyo,189-0003, JAPAN
042-391-1100
nagaminek@nichirei.co.jp
1st name | |
Middle name | |
Last name | Makoto Ichinohe |
CPCC Company Limited
Planning & Sales Department
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
NICHIREI BIOSCIENCES INC.
Profit organization
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 15 | Day |
2018 | Year | 03 | Month | 02 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036008
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