Verification of improvement effects on sleep quality by test-food intakes

Not Applicable

• Conditions: Healthy male/female adults

• Registration Number: JPRN-UMIN000048767
• Lead Sponsor: CPCC Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-01
• Study Completion: 2022-12-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects - - (1) taking in sleep-affecting foods, not less than three times a week, (2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period, (3) with not less than 30.0 kg/m2 of BMI, (4) with sleep-apnea syndrome, (5) with previous medical history of sleep disorder, (6) who have suffered from basal diseases, and being under medical treatment. (7) cannot use the activity tracker during the test period, (8) with an alcohol intake the day before the record of a sleep-questionnaire, (9) with not less than an overnight trip during the test period, (10) with extremely irregular dietary habit/life rhythm, (11) with a serious sleep-affecting rhinitis, (12) with excessive alcohol intake, (13) sleeping with their family in the same room, and might be woken up by the family during sleep, (14) with medical history of serious diseases, (15) with pregnancy, possibly one, or lactating, (16) with drug/food allergy, (17) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent, (18) who donated their blood components or blood (0.2 L) within the last month, (19) who donated his blood (0.4 L) within the last 3 months, (20) who donated her blood (0.4 L) within the last 4 months, (21) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (22) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (23) being determined as ineligible for participation by the principal/sub investigator - - .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index

Secondary Outcome Measures

Name	Time	Method
1. Oguri-Shirakawa-Azumi sleep inventory ver. MA 2. Epworth Sleepiness Scale 3. The Profile of Mood States Second Edition (short ver.) 4. Beck Depression Inventory-Second Edition 5. General Health Questionnaire-28 6. Activity 7. Salivary IgA 8. Laboratory values (blood biochemical/hematologic/urinalysis/physiologic tests)