Tokyo, Feb. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060647) titled 'Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism after Alcohol Consumption' on Feb. 10.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Ajinomoto Co., Inc.

Condition: Condition - N/A (healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To confirm whether the intake of foods containing amino acids promotes ethanol metabolism during alcohol consumption. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Control Food (amino acid - free) Interventions/Control_2 - Test food 1 (amino acid mixture1)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women who are 20 years of age or older at the time consent is obtained. 2) Individuals who have a drinking habit (4 or more times a month) 3) Individuals who, after receiving a full explanation of the research participation, fully understand it and give written consent of their own free will. Key exclusion criteria - 1) Individuals taking drugs or receiving medication related to liver function. 2) Individuals with a history of serious diseases of the digestive organs, liver, kidneys, etc. 3) Individuals who have been stopped from drinking by a doctor or are aware of problematic behavior due to alcohol consumption. 4) Those with a history of alcoholism. 5) Individuals who habitually consume foods or medicines that may affect test results, such as amino acids (amino acid preparations, foods, beverages, etc.), or alcohol care-related foods, etc., and who cannot stop taking them during the test period. 6) Individuals who answered "cannot drink" to the question about alcohol tolerance in the lifestyle survey. 7) Individuals who were determined to be unable to drink alcohol (DD type) based on the results of the alcohol sensitivity test. 8) Individuals who are pregnant, may be pregnant, or are breastfeeding. 9) Individuals who have been diagnosed with insomnia and are currently undergoing treatment, and those with irregular bedtimes and wake-up times 10) Individuals deemed unsuitable for participation in this study by the principal investigator for other reasons. Target Size - 41

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 05 Day Date of IRB - 2026 Year 02 Month 18 Day Anticipated trial start date - 2026 Year 02 Month 18 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067973

Disclaimer: Curated by HT Syndication.