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A Study of Long-Term Consumption of Plant-Derived Products on sleep -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study of Long-Term Consumption of Plant-Derived Products on sleep -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study of Long-Term Consumption of Plant-Derived Products on sleep

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050837
Enrollment
40
Registered
2023-04-14
Start date
2023-04-15
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

Sponsors

University of Nagasaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese males and females aged 20 to 64 years-old. 2) Subjects who have some sleep problems. 3) Subjects who defecate three to five a week. 4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects (who) 1) contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). 2) have a chronic disease and use medications. 3) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 4) use medications, functional foods, or supplements affecting sleep or stress. 5) drink excessive alcohol. 6) can't stop drinking from one day before each measurement (day before the sleep survey recording date). 7) with a history of and/or current mental illness associated with sleep disorder. 8) with a history of and/or current mental illness associated with sleep disorder. 9) sleeping with their family in the same room, and might be woken up by the family during sleep. 10) plan to go on a business trip (domestic or overseas) or trip (domestic or overseas) during the study period. 11) can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation and/or containing a large amount of sugar alcohol during this study. 12) regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation. 13) have declared allergic reaction to ingredients of test foods. 14) are under treatment for or have a history of drug addiction and/or alcoholism. 15) are pregnant or breastfeed or planning to become pregnant. 16) with extremely irregular dietary habit and/or irregular sleep hours and sleep habits due to irregular shift work, late night work, etc. 17) are participating in or willing to participate in other clinical studies. 18) are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Sleeping Questionnaire

Secondary

MeasureTime frame
Sleep-Related Questionnaire

Countries

Japan

Contacts

Public ContactKazumasa Nakamura

University of Nagasaki General Affairs and Planning Division

k_nakamura@sun.ac.jp095-813-5500

Outcome results

None listed

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