An exploratory study on the effect of food containing plant extract on sleep

An exploratory study on the effect of food containing plant extract on sleep - An exploratory study on the effect of food containing plant extract on sleep

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056913

Enrollment

Registered

2025-02-03

Start date

2025-02-04

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

None listed

Interventions

Food containing low-dose plant extract Food containing medium-dose plant extract Food containing high-dose plant extract Food not containing plant extract

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Subjects who can make self-judgment and are voluntarily giving written informed consent. 2.Healthy Japanese males aged 20 to 64 years-old. 3. Healthy subjects who attend school/work on weekdays, have no significant fluctuations in their daily bedtime/wake time, and are suspected of having sleep problems based on a preliminary questionnaire survey.

Exclusion criteria

Exclusion criteria: Subjects (who) 1.are currently attending a hospital or have a current medical history. 2.have been diagnosed as insomnia and have taken insomnia medications (including OTC medications or prescribed medications). 3.have been diagnosed with a mood disorder, including depression, and have taken medications to treat the disorder. 4.regularly use medications (except vitamins). 5.are unable to stop taking sleep-related supplements, functional foods, etc. during the study period. 6.are unable to stop consuming alcohol 4 hours or more before bedtime or caffeinated beverages 6 hours or more before bedtime during the test period. 7.work shift work, late-night work, or heavy labor. 8.are asked to report their normal bedtime and waking time, and whose bedtime is less than 6 hours. 9.consume excessive amounts of alcohol. 10.are pregnant, lactating, or intend to become pregnant 11.are living with a person who requires nursing care. 12. are unable to sleep alone on a bed or futon during the study period (two or more persons sleeping in the same room is acceptable). 13.are allergic to the test food. 14.are participating or will participate in other clinical trials at the start of this study. 15. are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
Sleep latency in 4th week of intake, WASO in 4th week of intake	—

Secondary

Measure	Time frame
Other sleep index, Questionnaire	—

Countries

Japan

Contacts

Public ContactChiemi Tanigawa

S'UIMIN INC. Research Support Division

c.tanigawa@suimin.co.jp+81-3-6276-3662

Outcome results