Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059582) titled 'Effects of a research beverage on water Intake in healthy subjects' on Nov. 2.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - EP Mediate Co., Ltd.

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

Objective: Narrative objectives1 - Investigate the effects of consuming the research food on daily fluid intake, using the control food as a reference Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consumption of the research food outside of scheduled meals and beverage intake times Interventions/Control_2 - Consumption of the control food outside of scheduled meals and beverage intake times

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Healthy males and females from 20 to 59 years of age (2) Subjects weighing 45 to 65 kg (priority given to those weighing 50 to 60 kg) (3) Subjects who have no aversion to the taste of research food and can consume it without any issues (4) Subjects who can finish a set meal (5) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study Key exclusion criteria - (1) Subjects who consciously adjust their beverage intake daily (including those who are restricted from consuming beverages due to illness) (2) Subjects who have excessive exercise habits (3) Subjects who have a smoking habit (4) Subjects who consume alcohol on a regular basis (Alcohol equivalent of 40 g or more per day) (5) Subjects who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication, and those who are scheduled for surgery (6) Subjects who have dietary restrictions due to heart disease, liver disease, digestive disorders, kidney disease, diabetes, or other illnesses (7) Subjects who have a scheduled menstruation during the study period (Intake Phase I and II) (8) Subjects who work in shifts, work late at night, and have an irregular daily rhythm (9) Subjects who have participated in other clinical studies, trials, or human studies within one month prior to the start of this study (10) Subjects who plan to become pregnant or breastfeed during the study period (11) Subjects who are judged to be unsuitable as a subject based on the results of the preliminary examination (12) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey (13) Subjects who are judged as unsuitable for the study by the investigator for other reason Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 23 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 11 Month 03 Day Last follow-up date - 2025 Year 12 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068150

Disclaimer: Curated by HT Syndication.