Influence of wake-up time and intervention with rice balls and coffee beverages on the circadian rhythm of core body temperature.

UMIN ID: UMIN000054216

Registered date:24/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy individuals
• Date of first enrollment: 2024/04/24
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

No breakfast
Rice ball
Coffee beverage
Rice ball, Coffee beverage

Outcome(s)

• Primary Outcome: changes in the circadian rhythm of core body temperature
• Secondary Outcome: Changes in sleep, activity level, electrocardiogram, glucose concentration in interstitial fluid, cortisol concentration in saliva, performance, daily dietary intake, daily activities, daily mood, and OSA sleep survey.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Individuals with extremely irregular eating and sleeping habits. 2. Individuals with health conditions (those with medications affecting metabolism, mental disorders, severe cardiovascular diseases, cancer, pregnant individuals, individuals with a history of gastrointestinal surgery). 3. Individuals engaged in shift work or night shift jobs 4. Individuals who regularly use sleeping pills or sleep supplements 5. Individuals who typically consume caffeine-containing beverages equivalent to 400mg or more of caffeine per day (approximately 3 cups for coffee in a mug (200ml each), approximately 10 cups for green tea, hojicha, or oolong tea, or more than 6 cups for black tea) 6. Individuals with food allergies to the target food ingredients or those who experience significant physical changes in response to caffeine intake." 7. Students attending lectures given by the Department of Public Health, Hiroshima University.

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: Noevia, TOKIWA Pharmaceutical Co.,Ltd