Tokyo, Dec. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060227) titled 'Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals' on Dec. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - N/A(healthy adults)
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - The purpose of this study is to understand the factors influencing blood glucose changes caused by daily alcohol consumption and snacking.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 35
years-old
Gender - Male
Key inclusion criteria - 1)Toshiba corporate cohort registrants who have provided consent to participate in this study
2)Male individuals aged 35 or older but under 60 at the start of the study
3)Individuals who drink alcohol 2 to 5 times per week
4)Individuals whose single drinking session contains 20g or more of alcohol
5)Individuals with no smoking habit
6)Healthy individuals not undergoing regular medical treatment or taking medication
7)Individuals who have never experienced skin issues (such as rashes, eczema, redness) from using cosmetics or quasi-drugs and do not consider their skin sensitive
8)Individuals able to wear Libre 2 for approximately 2 weeks (maximum 14 days) and maintain a log regarding alcohol consumption, complete a hangover questionnaire, and record snacking and hunger levels
9)Individuals employed at Toshiba headquarters at the study start date who can come to a designated location at Toshiba headquarters during non-working hours (lunch break) for Libre 2 application and data retrieval completion
10)Individuals who can comply with the Libre 2 service regulations and instruction manual contents
11)Individuals who can personally prepare a smartphone (iPhone or Android) meeting the requirements for FreeStyle Libre Link compatibility
12)Individuals with no scheduled MRI, X-ray, or CT scans during the Libre wear period
13)Individuals with no scheduled airplane travel during the Libre wear period
Key exclusion criteria - 1)Individuals who may change their lifestyle habits during the study period
2)Individuals who participated in another clinical trial involving interventions within one month prior to registering their consent to participate in this study, or who plan to participate in another clinical trial involving interventions during the study period
3)Individuals who currently have, or have had within the past three months, a habit of continuously consuming foods with functional claims, health foods, or supplements that claim to affect blood glucose levels, or who plan to consume such products during the study period
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 21 Day
Date of IRB - 2025 Year 11 Month 21 Day
Anticipated trial start date - 2026 Year 01 Month 13 Day
Last follow-up date - 2026 Year 02 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068859
Disclaimer: Curated by HT Syndication.
