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

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000050837
• Lead Sponsor: niversity of Nagasaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-14
• Study Completion: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified