Confirmatory study of the improving effect of sleep quality by test-food intake
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000048798
- Lead Sponsor
- M&I Science CORP.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sleep quality
- Secondary Outcome Measures
Name Time Method (Secondary outcomes) Indexes on sleeping,Tests for mood status (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events