Effect of ingestion of trial supplement on sleep. A randomized, placebo controlled, double blind, cross-over study

Not Applicable

• Conditions: Healthy subject

• Registration Number: JPRN-UMIN000022069
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of sleep or fatigue. 2) Subjects with excessive alcohol-drinking behaviors. 3) Subjects who cannot stop drinking alcohol during study period I and II 4) Subjects who are under the medication, counseling, or exercise therapy. 5) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease. 6) Subjects who have under treatment or a history of sleep apnea syndrome or is suspected of sleep apnea syndrome. 7) Night and day shift worker or manual laborer 8) Working days and holidays are irregular 9) Subjects who have mental illness or insomnia. 10) Subjects who will use medicine for Perennial allergic rhinitis in study period. 11) Heavy smoker 12) Subjects having possibilities for emerging allergy related to the study foods. 13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 14) Subjects who have heavy menstrual cramps and premenstrual syndrome. 15) Subjects who are planned to participate in other clinical study 16) Subjects who are judged as unsuitable for the study by the investigator for other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified