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Evaluation of effects of food intake or meditation on sleep state

Evaluation of effects of food intake or meditation on sleep state - Evaluation of effects of food intake or meditation on sleep state

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046025
Enrollment
120
Registered
2021-11-12
Start date
2021-03-19
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

Perform meditation for 1 week Intake test food 1 for 1 week Intake test food 2 for 1 week Intake test food 3 for 1 week Intake test food 4 for 1 week Intake placebo for 1 week No treatment

Sponsors

Shiba Palace Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Japanese males and females aged 30 to 59 years old 2) Subjects who lead a regular life (sleep almost constantly) 3) Subjects who work full-time on weekdays (Monday through Friday) and have weekends and holidays off 4) Healthy adults who are not visiting hospitals or taking medication for the treatment of illness 5) Subjects who are dissatisfied with their sleep (difficulty falling asleep, waking up in the middle of sleep, difficulty waking up, etc.) 6) Subjects who are aware of chronic fatigue 7) Subjects who can consent not to drink alcohol though the test period 8) Subjects who sleep alone in bed 9) Subjects who use beds with mattress whose thickness is within the range of 5 cm or more and 50 cm or less 10) Subjects who can put a device (175 mm x 175 mm, 13 mm thin) under the mattress to measure sleep conditions 11) Subjects who use smartphones with iOS 12.0.0 or higher, Android 6.0 or higher 12) Subjects who can consent to install an application to their smartphones to monitor their sleep conditions 13) Subjects who sleep an average of 5 hours or more 14) Subjects who can consent to consume around 1GB of data to upload to the application to monitor their sleep conditions

Exclusion criteria

Exclusion criteria: 1) Subjects who are undergoing treatment for insomnia or sleep disorders 2) Subjects who are said to snore frequently during the night, and those who are often awakened by snoring 3) Smokers 4) Subjects who have a habit of drinking at least once a week 5) Subjects with or suspected of having a mental illness such as depression 6) Subjects with a history of alcoholism, drug dependence, or abuse 7) Subjects who regularly use medicines or health foods (related to sleep, stress, and fatigue) that may affect the test results. 8) Subjects who are currently using antihistamines regularly or who plan to use them during the study period 9) Subjects who plan to be transferred or change jobs during the test period 8) Shift workers or midnight shift workers 8) Subjects who plan to travel abroad during the test period 10) Subjects who plan to travel domestically or go on domestic business trips with overnight stays during one or more of the following periods: the pre-observation period, the test food intake period, and the meditation period

Design outcomes

Primary

MeasureTime frame
OSA sleep inventory MA version at 0-1week on term 1-6 and untreated term

Secondary

MeasureTime frame
Sleep monitoring Diary Questionnaire

Countries

Japan

Contacts

Public ContactMiwa Kaneko

SOUKEN Co., Ltd Management Division

m_kaneko@mail.souken-r.com03-5408-1555

Outcome results

None listed

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