Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese male and female who are between 20 and 35 years old at the time of obtaining written consent. 2.Subject who is aware of poor sleep quality. 3.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who is taking medication or under medical treatment due to serious illness. 2.Subject who is under exercise therapy or dietetic therapy. 3.Subject who may develop allergies due to the test foods. 4.Subject with current or history of drug and alcohol dependence. 5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, 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 with extremely irregular lifestyle habits such as eating and sleeping. 8.Subject who has an extremely unbalanced diet. 9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 10.Subject who uses health foods, supplements, and medicines that affect brain function (improvement of sleep) and intestinal function. 11.Subject who uses health foods and supplements that affect immune function. 12.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. 13.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. 14.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15.Subject who has difficulty observing records on various survey forms. 16.Subject who is judged as an inappropriate candidate according to the screening data. 17.Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Saliva s-IgA, VAS, stress record (life questionnaire) (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed