Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059472) titled 'Observational study of the association between alcohol consumption and biological data in daily life' on Oct. 20.

Study Type: Observational

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will be conducted to examine the association between alcohol consumption and biological data in daily life. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Adults aged 20 years or older and under 40 years (2) Male and female working adults (3) BMI less than 30.0 (4) Non-smokers (no smoking within the past year) (5) Individuals who have a habitual alcohol consumption in their daily life (6) Users of an iPhone with iOS 16 or later, or an Android device with OS 10 or later (7) Individuals who have sufficient understanding of the purpose and details of this study, have the capacity to give consent, and can provide their own consent via electronic informed consent after receiving an adequate explanation Key exclusion criteria - (1) Individuals currently receiving treatment with any medication or herbal medicine (occasional use allowed). (2) Individuals with a history or current diagnosis of serious diseases affecting the heart, liver, kidneys, digestive system, or other major organs. (3) Individuals with hay fever (autumn pollen) or allergic rhinitis (seasonal or perennial). (4) Individuals under dietary or exercise therapy supervised by a physician. (5) Individuals who routinely use over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, Foods with Function Claims, or supplements that may affect the autonomic nervous system, metabolism, or sleep (those who can stop use after consent and during the study may participate). (6) Individuals consuming excessive alcohol (60 g or more pure alcohol per day). (7) Individuals with extremely irregular eating habits or lifestyles, such as shift or night workers. (8) Individuals who participated in another clinical trial within one month before consent (except for psychological studies under the AQI), those currently or planning to participate during this study, or within four weeks after its completion. (9) Individuals who have experienced major life stress (for example, relocation, job change, or bereavement) within three months before consent, or are expected to during the study. (10) Individuals with known drug or food allergies. (11) Individuals unable to consume alcohol due to intolerance. (12) Individuals who are pregnant, lactating, possibly pregnant, or planning pregnancy during the study. (13) Individuals unable to wear a wrist type wearable device daily. (14) Individuals judged unsuitable for participation by the principal investigator. Target Size - 75

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 14 Day Date of IRB - 2025 Year 10 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 21 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068024

Disclaimer: Curated by HT Syndication.