Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063306) titled 'Investigation of the relationship between beverage choice in daily life and biometric data: An observational study' on Oct. 16.
Study Type:
Observational
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will be conducted to investigate the relationship between beverage choice in daily life and biometric data.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Adults aged 20 years or older and under 40 years
(2) Male and female working adults
(3) BMI less than 30.0
(4) Non-smokers (no smoking within the past year)
(5) Individuals who have a habitual alcohol consumption in their daily life
(6) Office workers who are able to purchase, or routinely purchase, beverages from office vending machines or similar facilities during working hours
(7) Users of an iPhone with iOS 16 or later, or an Android device with OS 10 or later
(8) Individuals who have sufficient understanding of the purpose and details of this study, have the capacity to give consent, and can provide their own consent via electronic informed consent after receiving an adequate explanation"
Key exclusion criteria - (1) Individuals currently receiving treatment with any medication or herbal medicine (occasional use permitted).
(2) Individuals with a history or current diagnosis of serious diseases affecting the heart, liver, kidneys, digestive system, or other major organs.
(3) Individuals with hay fever (autumn pollen) or allergic rhinitis (seasonal or perennial).
(4) Individuals under dietary or exercise therapy supervised by a physician.
(5) Individuals who regularly use over the counter drugs, quasi drugs, Foods for Specified Health Uses, Foods with Function Claims, or supplements that may affect the autonomic nervous system, metabolism, or sleep (those who can stop use after consent and during the study may participate).
(6) Individuals who consume excessive alcohol (60 g or more pure alcohol per day).
(7) Individuals with extremely irregular eating habits or lifestyles, such as shift or night workers.
(8) Individuals who participated in another clinical trial within one month before consent (except for psychological studies under the AQI), those currently participating, those planning to participate during this study, or within four weeks after its completion.
(9) Individuals who have experienced significant stress from major life events (such as relocation, job change, or bereavement) within three months before consent, or are expected to during the study.
(10) Individuals with known drug or food allergies.
(11) Individuals unable to consume alcohol due to intolerance.
(12) Individuals who are breastfeeding, pregnant, possibly pregnant, or planning pregnancy during the study.
(13) Individuals unable to wear a wrist type wearable device daily.
(14) Individuals judged unsuitable for participation by the principal investigator.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 08 Day
Anticipated trial start date - 2026 Year 10 Month 16 Day
Last follow-up date - 2026 Year 12 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072464
Disclaimer: Curated by HT Syndication.
