Tokyo, Nov. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059814) titled 'Online Experiment on the Mood-Refreshing Effects of Beverages' on Nov. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.

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

Objective: Narrative objectives1 - This experiment aims to obtain fundamental insights that can be applied to the development of new beverages. Healthy adult males will be recruited, and they will be asked to perform a task designed to induce stress. A short break for mood refreshment will be provided during the preparation phase of the task. During this break, participants will consume a designated beverage. Two beverage conditions will be prepared: one containing alcohol and one without alcohol. The assignment of beverage type will be determined randomly. By using this procedure, we aim to clarify whether alcohol acts as a positive means of mood refreshment under stress, or conversely, whether it has adverse effects. The findings will contribute to exploring new added value for future beverage development. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Beer Consumption Group: Participants will consume two bottles of beer in total, drinking one bottle every 15 minutes. To ensure that they remain present and in front of the screen, they will be instructed to click a Zoom reaction button every 10 minutes. Interventions/Control_2 - Control Group: Participants will remain seated at rest. To ensure that they remain present and in front of the screen, they will be instructed to click a Zoom reaction button every 10 minutes.

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - Participants who indicate their willingness to participate and provide informed consent after understanding the study explanation will be included in the research.

In this study, participants will be recruited from the NTT Com Research Monitor, a panel managed by NTT Com Online Marketing Solutions. The NTT Com Research Monitor consists of approximately 8 million registered individuals ranging in age from their teens to their seventies. This service regularly conducts web-based surveys and interviews to collect opinions on systems, policies, and other topics. All registered members have agreed to the terms and conditions regarding information provision, including the handling of personal data, through NTT Com Research.

For this study, individuals registered with this service will serve as the target population.

Habitually consumes Asahi Super Dry beer at least once per month, without experiencing immediate discomfort or adverse health effects from consumption. Non-smoker. Does not exhibit alcohol flushing reactions. Able to comfortably consume two 350 mL cans of 5% alcohol Asahi Super Dry beer within approximately 30 minutes (one can every ~15 minutes). Able to store the study beverage (two 350 mL cans of Asahi Super Dry) in a refrigerator until the study session. Able to participate in the study alone via Zoom from home on the day of the session. Has a stable internet connection and can operate Zoom. Able to measure heart rate using a smartphone app or, if not possible, a wearable device such as an Apple Watch, and provide real-time heart rate measurements. Key exclusion criteria - Individuals who may experience adverse health effects from alcohol consumption. Individuals who have been advised by a physician to limit alcohol intake, or who need to avoid alcohol due to medical conditions or medication use. Individuals whose alcohol consumption habits exceed the cutoff score on the pre-screening questionnaire (AUDIT score >= 8, calculated from responses to questions 15-24). Individuals who exhibit alcohol flushing reactions. Current smokers. Individuals for whom study conditions or environment cannot be adequately met (e.g., unstable internet connection, high levels of background noise, difficulty sitting for extended periods, inability to follow study instructions.) Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 04 Day Date of IRB - 2025 Year 11 Month 13 Day Anticipated trial start date - 2025 Year 11 Month 29 Day Last follow-up date - 2025 Year 12 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068397

Disclaimer: Curated by HT Syndication.