Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063102) titled 'An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - MIS Co.,Ltd.

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

Objective: Narrative objectives1 - To verify whether the detection accuracy of digital biomarkers related to alcohol consumption has reached a practical level, while exploring the feasibility of classifying patterns of individual variation, thereby contributing to the development of future behavior-change feedback services. Basic objectives2 - Others

Intervention: Interventions/Control_1 - fitness tracker

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Japanese men aged 20 to 59 at the time of obtaining web consent. 2.Subjects who regularly consume alcohol at least once a week. 3.Subjects who can wear a wearable device every day during the observation period, including while sleeping. 4.Subjects who own a smartphone capable of installing applications for wearable devices and who can agree to the terms of use for the wearable devices and applications used in this study. 5.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study. Key exclusion criteria - 1.Subjects who use devices, such as pacemakers, or medications that may affect their heart rate. 2.Subjects who are taking medication or under medical treatment. 3.Subjects who are under exercise therapy or dietetic therapy. 4.Subjects with conditions such as eczema, allergies, or sensitive skin that may cause dermatitis or other skin problems when wearing a wearable device. 5.Subjects with a current or past history of drug or alcohol dependence. 6.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 7.Subjects who are currently pregnant or breastfeeding, or who may become pregnant or start breastfeeding during the study period. 8.Subjects who have difficulty recording their alcohol consumption and lifestyle habits as required by the Alcohol Consumption and Lifestyle Questionnaire. 8. Subjects who have difficulty complying with recording information on alcohol consumption and lifestyle questionnaires. 9.In addition, subjects whom the head of a research institution, a contract research organization, or a joint research organization determines to be unsuitable for participation in the relevant study. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 12 Day Date of IRB - 2026 Year 08 Month 20 Day Anticipated trial start date - 2026 Year 09 Month 17 Day Last follow-up date - 2026 Year 12 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072222

Disclaimer: Curated by HT Syndication.