Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063598) titled 'Effects of Food Ingredient Intake During Me-Time Activities on Psychological and Behavioral Outcomes' on Nov. 13.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - 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 investigate the effects of food ingredients contained in beverages consumed during Me-time, defined as the period between dinner and bedtime spent in a private setting after work or school on a day preceding another work or school day, on psychological and behavioral outcomes immediately after consumption and on the following day. Previous survey findings suggested that consuming more stimulating beverages, compared with relaxing beverages, may enhance the value of Me-time, including improvements in sleep quality and motivation the next morning. Through a three-week intervention, this study will evaluate the effectiveness of individual food ingredients rather than beverages as a whole and generate evidence to improve understanding of the effects of beverage ingredients in daily life and to support future product development. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - During Me-Time Activities, the following three conditions will be assigned to each participant in a randomized order over the intervention period: - A week during which participants consume one bottle of a control beverage (Drink P) per day. - A week during which participants consume one bottle of a beverage containing added flavoring ingredients (Drink Q) per day. - A week during which participants do not consume either study beverage. Interventions/Control_2 - During Me-Time Activities, the following three conditions will be assigned to each participant in a randomized order over the intervention period: - A week during which participants consume one bottle of a control beverage (Drink R) per day. - A week during which participants consume one bottle of a beverage containing added flavoring ingredients (Drink S) per day. - A week during which participants do not consume either study beverage.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Eligible participants are healthy adult men and women who have understood the contents of this study and provided written informed consent. Participants must habitually use social media or browse the internet during their Me-Time and must be able to receive 10 bottles of the study beverages and store them under refrigerated conditions during the study period (up to 3 weeks).

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 have difficulty consuming beverages containing herbal flavorings or carbonated beverages used in this study, who do not habitually engage in social media use or internet browsing during their Me-Time, or who are considered unable to comply with the study procedures and assessments will be excluded. Target Size - 90

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 10 Month 29 Day Date of IRB - 2026 Year 10 Month 29 Day Anticipated trial start date - 2026 Year 10 Month 29 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072693

Disclaimer: Curated by HT Syndication.