Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060421) titled 'Alcohol absorption inhibitory effect confirmation test by food intake' on Jan. 21.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kewpie Corporation
Condition:
Condition - Healthy people
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We examine whether consuming food and alcoholic beverages simultaneously inhibits the absorption of alcohol into the body.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Alcohol and food intake
Interventions/Control_2 - Alcohol and placebo intake
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male
Key inclusion criteria - 1) Japanese males aged 30 to 59 years
2) Subjects who drink alcohol 3 or more times a week
3) Subjects who can drink a prescribed amount of alcohol
4) Subjects with a BMI between 18.5 and 30.0
Key exclusion criteria - 1) Subjects who have been diagnosed with liver dysfunction by a medical checkup
2) Subjects taking drugs related to liver function
3) Subjects undergoing regular medical treatment
4) Subjects with a history of serious diseases of the digestive organs, liver, kidneys, etc.
5) Subjects who regularly ingest health food or medicine that affects liver function
6) Subjects having drug and food allergy
7) Subjects who have participated in other clinical study within one month before the study or plan to participate in other clinical study after informed consent to the study
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Date of IRB - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2026 Year 01 Month 24 Day
Last follow-up date - 2026 Year 03 Month 07 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069118
Disclaimer: Curated by HT Syndication.