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A confirmation study of test food in alcohol metabolism

Not Applicable
Conditions
healthy subject
Registration Number
JPRN-UMIN000049869
Lead Sponsor
Morinaga & Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who (1)infected by hepatitis virus. (2)had or suspected infectious disease such as COVID-19, or who had close contact with a COVID-19 patient. (3)cannot drink alcohol at all. (4)showed strong positive reaction in patch test of alcohol. (5)aware of losing control due to drinking alcohol (entanglement, anger, yelling, crying, etc.) (6)intake excessive alcohol. (Those who daily consume average more than about 60g of pure alcohol) (7)weigh less than 45 kg or more than 90 kg. (8)have current medical history or past medical history of diabetes. (9)constantly use medicines that may affect test results. (cephem antibiotics such as Cefaclor, Cefotiam, Cefdinir, Anti-alcoholic drugs such as Disulfiram, Cyanamide etc.).Those taking health foods and supplements (turmeric, ornithine, etc.) daily, and those who may take or take them during the test period. (10)have current medical history or past medical history of serious disease in heart, liver, kidney, digestive organ. (11)are planning some kind of treatment during the study period. (12)Females who are pregnant or could become pregnant, and who are lactating. (13)have allergies to medicines and foods (especially milk and gelatin). (14)participated clinical trial within 4-weeks prior to the current study and/or who have planning to participate the other clinical tests. (15)donated over 200mL blood and/or blood components within the last one month to the current study. (16)Males who donated over 400mL blood and/or blood components within the last three months to the current study. (17)Females who donated over 400mL blood and/or blood components within the last four months to the current study. (18)Males who exceed 1200 mL of blood sampling volume including this study within the last 12 months. (19)Females who exceed 800 mL of blood sampling volume including this study within the last 12 months. (20)were judged ineligible for enrollment in the study by the principal investigator or sub-investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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