Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059832) titled 'Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Healthy people
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Investigating Changes in Core Body Temperature Rhythms Following One-Month Wake-Up Time Restriction and Breakfast Intake Intervention
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - No breakfast until noon for 4 weeks
Interventions/Control_2 - Breakfast (450kcal) for 4 weeks
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Healthy adults aged 18 years or older and under 40 years
Individuals who do not have a habit of eating breakfast
(defined as those who, on at least five days per week, typically consume only snacks, fruits, dairy products, or beverages in the morning; only nutrient supplements or energy drinks; or consume nothing at all in the morning)
Individuals who maintain generally regular eating and sleeping habits
Individuals who are able to participate during the specified study period and visit the laboratory on the designated days
Individuals who can download and use the required mobile application on their own smartphone
Key exclusion criteria - Individuals engaged in shift work or night work
Individuals with extremely irregular daily routines
Individuals who regularly use sleeping medications or sleep supplements
Individuals with allergies to any of the following foods: wheat, eggs, milk, soy, or walnuts
Target Size - 40
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 09 Month 16 Day
Date of IRB - 2025 Year 09 Month 16 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2027 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068420
Disclaimer: Curated by HT Syndication.