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A evaluation study of the effect of test food on human sleep. -Open Study-

A evaluation study of the effect of test food on human sleep. -Open Study- - A evaluation study of the effect of test food on human sleep.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046579
Enrollment
20
Registered
2022-01-10
Start date
2022-01-10
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

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females from 30 to 59 years of age. 2. Subjects with a PSQI-J global score of 6 or higher at the time of screening test. 3. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are currently under treatment for sleep, stress and fatigue, and who are using medicines and health foods related to sleep, stress and fatigue. 2. Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day). 3. Subjects who aren't abele to stop eating foods and drinks high in caffeine from 15:00 to bedtime during this research period. 4. Subjects who are midnight-shift worker or shift worker. 5. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases. 6. Subjects who have chronic diseases and take medication on a daily basis. 7. Subjects who have a history of pollinosis or a current medical history, and who plan to use or take the drug during this research period. 8. Subjects who have been diagnosed with sleep apnea syndrome. 9. Subjects who have sensitive skin and may cause skin inflammation with adhesive plasters or adhesive tape. 10. Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators. 11. Subjects who have a history or current condition of drug or alcohol dependence. 12. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during this research period. 13. Women with severe symptoms such as menstrual pain and premenstrual syndrome. 14. Subjects who have food allergy. 15. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests. 16. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 17. Subjects who plan to travel abroad, including overseas travel, during this research period. 18. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Design outcomes

Primary

MeasureTime frame
EEG during sleep (Sleep scope)

Secondary

MeasureTime frame
The Japanese version of the Pittsburgh Sleep Quality Index OSA sleep inventory MA version Visual Analogue Scale

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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