A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumptio

Not Applicable

• Conditions: ot applicable

• Registration Number: JPRN-UMIN000037893
• Lead Sponsor: CPCC Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-09
• Study Start: 2020-09-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who 1.are given continuous treatment by taking medicines. 2.constantly use oral medicines having a possibility of affecting test results. 3.constantly use food having a possibility of affecting test results, such as food for specific health use. 4.have current and/or previous medical history of serious disease. 5.have current and/or previous medical history of sleep disorder. 6.self-aware about their sleep apnea. 7.awake during sleep more than two times a week due to night urination. 8.have allergic rhinitis. 9.use pacemaker. 10.have previous medical history of allergy for medicine and/or food. 11.those BMI are over 30 kg/m2. 12.tend to have skin rash with adhesive tape due to skin hypersensitivity. 13.are pregnant or lactating. 14.have extremely irregular dining and life habits. 15.excessive alcohol intake. 16.are not be able to avoid alcohol intake during test period. 17.are not be able to use electroencephalograph during test period. 18.have plan lodging by travel and/or business trip. 19.are participating the other clinical tests, participated within 4-weeks prior to the current study and/or plan to participate the other clinical tests. 20.donated over 200mL blood and/or blood components within the last one month. And 21.Males who donated over 400mL blood and/or blood components within the last three month. 22.Females who donated over 400mL blood and/or blood components within the last four month. 23.Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 24.Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 25.Others who have been determined ineligible by principal investigator or sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Condition of sleep, stress and fatigue, assessed by electroencephalography, OSA sleep inventory, VAS questionnaire for feeling of fatigue, POMS2 short version or St. Mary's hospital sleep questionnaire

Secondary Outcome Measures

Name	Time	Method
Incidence rate of adverse events and side effects