Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness

Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness - Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060842

Enrollment

Registered

2026-03-06

Start date

2025-08-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Single intake of the test food on the day of the study Single intake of the placebo food on the day of the study

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Adult male full-time employees of the Research Headquarters whose workplace is the Meiji Innovation Center at the time of obtaining consent. 2. Subjects who have received sufficient explanation about the purpose and content of this study, possess the capacity to consent, and have voluntarily agreed to participate after fully understanding the information provided.

Exclusion criteria

Exclusion criteria: 1. Subjects currently receiving treatment (including medication) for any disease. 2. Subjects with a Body Mass Index (BMI) greater than 25. 3. Subjects whose usual sleep duration, calculated from self reported bedtime and wake up time, is less than 6 hours. 4. Subjects with suspected sleep disorders. 5. Subjects unable to comply with study procedures. 6. Subjects engaged in shift work, night work, or whose primary occupation involves physical labor. 7. Subjects who consume excessive amounts of alcohol (defined as consuming more than 1 go of sake [equivalent to one 500??mL bottle of beer, one double shot of whiskey, or 0.6 go of shochu] three or more times per week). 8. Subjects who smoke. 9. Subjects with known food allergies. 10. Subjects with lactose intolerance. 11. Subjects who self identify as caffeine dependent. 12. Subjects currently participating in or planning to participate in another clinical trial at the start of this study. 13. Subjects deemed inappropriate for participation by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Maintenance of Wakefulness Test (MWT)	—

Secondary

Measure	Time frame
Karolinska Sleepiness Scale (KSS) Microsleep Latency Oguri-Shirakawa-Azumi Sleep Inventory, Middle-Aged and Aged version (OSA-MA)	—

Countries

Japan

Contacts

Public ContactKentarou Nakamura

Meiji Co., Ltd. Nutrition and Food Function Group

kentarou.nakamura@meiji.com042-632-5847

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026