Effects of consumption of the test food on sleep quality

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000041864
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-20
• Study Start: 2022-02-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who 1. undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction, and have a pacemaker or an implantable cardioverter defibrillator 2. undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage such as gamma-aminobutyric acid, crocetin, L-theanine, lactic acid bacteria that may affect sleep quality in daily 4. currently taking medicines (include herbal medicines) and supplements 5. allergic to medications and/or the test-food-related products. Particularly, gelatin or fish allergy 6. have factors that affect their sleep due to their home environment 7. Subjects who have irregular sleep habits due to irregular lifestyles (irregular meal timing, insufficient sleep, or night shifts, etc.) 8. have nocturia 3 times or more 9. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 10. pregnant, breast-feeding, and planning to become pregnant 11. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 12. under treatment of sleeplessness or sleep disorder 13. judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified