Healthy subjects
Conditions
Sponsors
M&I Science CORP.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and femaless who are between 20 and 65 years old at the time of obtaining written consent. 2.Subject who is aware of poor sleep quality. 3.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subject who is taking medication or under medical treatment because of some serious illness. 2.Subject who is under exercise therapy or dietetic therapy under the supervision of a physician. 3.Subject who has an allergy for test food. 4.Subject who has or had a history of either medicine or alcohol dependence syndrome. 5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders(Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 6.Subject with irregular life rhythms due to night shifts or shift work. 7.Subject who has extremely irregular lifestyle habits such as eating and sleeping. 8.Subject who has an extremely unbalanced diet. 9.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. 10.Subject who uses health foods, supplements, medicines that contain ingredients that affect sleep quality. 11.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period. 12.Subject who has collected more than 200 mL of blood or donated more than 400 mL of blood within 1 month or 3 months from the date of consent acquisition. 13.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14.Subject who has difficulty observing records on various survey forms. 15.Subject judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR. 16.Others who are judged by the investigator to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleep quality | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Indexes on sleeping,Tests for mood status (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
M&I Science CORP. Clinical Development Department
Outcome results
None listed