A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers - A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers

Soiken Inc.0 sites36 target enrollmentNovember 7, 2022

ConditionsHealthy volunteers

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy volunteers
Sponsor: Soiken Inc.
Enrollment: 36
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 7, 2022

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Soiken Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\)Subjects receiving a medical treatment for sleep disorders 2\)Subjects receiving a medical treatment for serious cardio\-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3\)Subjects receiving a medical treatment for chronic diseases such as diabetes, hypertension and dyslipidemia 4\)Subjects who take regularly medicines and quasi\-drugs having the effects on sleep quality 5\)Subjects who take regularly health food (e.g. Food with Functional Claims) having the effects on sleep quality 6\)Subjects whose lifestyles are irregular because of night shift or others 7\)Subjects who wake up for urination 2 times or more during nocturnal sleep 8\)Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 9\)Subjects who have smoking habit 10\)Subjects who have the possibility of developing allergic symptoms by the test food 11\)Subjects who live with their infants less than 1 year old 12\)Subjects who sleep with others in a bedroom 13\)Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 14\)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 15\)Female subjects who are pregnant or lactating, or intending to become pregnant during the study 16\)Subjects deemed unsuitable by the investigator