Tokyo, Nov. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059812) titled 'Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities' on Nov. 20.

Study Type: Interventional

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

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

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

Objective: Narrative objectives1 - This study aims to exploratorily examine the psychological and behavioral effects of beverage characteristics during Me-Time, which is defined as habitual activities performed before bedtime on evenings preceding work or academic obligations. Findings from preliminary research suggest that the consumption of stimulating beverages, rather than those with relaxing properties, may enhance the perceived value of Me-Time for instance, by improving sleep quality.Through a three-week intervention, this study seeks to evaluate the efficacy of a newly developed beverage. The insights obtained will contribute to a deeper understanding of the role of beverages in everyday life and will inform future product development. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The control beverage (Drink P) used in this study is a non-sweetened drink without added flavoring agents, while the test beverage (Drink Q) is a non-sweetened drink containing the herbal flavoring agent nerol (Flavor X). Nerol is approved as a food additive in Japan and is also recognized internationally as a food flavoring by the European Food Safety Authority (EFSA) and the Flavor and Extract Manufacturers Association (FEMA) in the United States. The acute oral toxicity (LD50) of nerol in rats is reported to be 4,500 mg/kg. In this study, Drink Q contains 6 mg of nerol per bottle, and participants will consume one bottle per day. Interventions/Control_2 - A beverage labeled with only functional claims in textual form (Drink R) versus a beverage labeled with marketing-oriented messaging (Drink S).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female 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. Key exclusion criteria - Individuals who experience discomfort when consuming beverages containing herbal flavoring, which is a characteristic of the target drink in this study; those who find carbonated beverages unpleasant; and those who may have difficulty engaging in activities in accordance with the experimental conditions will be excluded from participation. Target Size - 100

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 08 Month 27 Day Date of IRB - 2025 Year 10 Month 03 Day Anticipated trial start date - 2025 Year 10 Month 03 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=R000067517

Disclaimer: Curated by HT Syndication.