A preliminary study to confirm the effects of two test foods on alcohol metabolism

UMIN ID: UMIN000056566

Registered date:11/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healty volunteers
• Date of first enrollment: 2025/01/13
• Target sample size: 14
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral intake of test food A for 2 weeks
Oral intake of test food B for 2 weeks

Outcome(s)

• Primary Outcome: Blood alcohol concentration
• Secondary Outcome: POMS2

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male
• Exclude criteria: 1) Those who have been taking medication regularly within 3 months prior to the start of the study (Excluding temporary painkillers, cold medicines, etc.) 2) Those with serious illnesses (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illnesses 3) Those with a history of serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or digestive system disease 4) Those who have regularly taken specific health foods, functional foods, health foods (including supplements), etc., that may affect the study, at least three times a week within three months prior to the start of the study. 5) Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that may affect the study during the study period. 6) Those who cannot drink alcohol 7) Those who regularly use medicines, health foods, foods for specified health uses, or foods with functional claims that may affect liver function 8) Night shift and day/night shift workers 9) Those who regularly drink large amounts of alcohol 3 or more days a week (40g or more of pure alcohol per day) 10) Those with extremely irregular eating habits or those with irregular lifestyles such as working night shifts 11) Those with drug or food allergies 12) Those who are currently participating in a clinical trial of another drug or health food, have completed the trial within 4 weeks, or are scheduled to participate in another clinical trial while participating in this trial. 13) Those who are deemed ineligible to participate in this study by the investigator

Related Information

• Primary Sponsor: MITSUBISHI GAS CHEMICAL COMPANY, INC.
• Source(s) of Monetary Support: MITSUBISHI GAS CHEMICAL COMPANY, INC.