Healthy subjects
Conditions
Interventions
Intake of the active food for 12 weeks
Intake of the placebo food for 12 weeks
Sponsors
others
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women between 20 and 65 years of age at the time of obtaining written informed consent. 2.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects who are taking medication or under medical treatment. 2.Subjects who are under exercise therapy or dietetic therapy. 3.Subjects who have any kind of allergy, such as to food or pollen, regardless of the test food. (Especially subjects with an egg allergy.) 4.Subjects with current or history of drug dependence or alcohol dependence. 5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6.Subjects with irregular life rhythms due to night shifts or shift work. 7.Subjects with extremely irregular lifestyle habits such as eating and sleeping. 8.Subjects who are or may be of excessive alcohol consumption. 9.Subjects who have an extremely unbalanced diet. 10.Subjects with serious current or past medical conditions such as brain disease, malignancy, immunological disorders, diabetes, liver disease (including hepatitis), kidney disease, heart disease, thyroid disorders, adrenal gland disorders, or other metabolic diseases. 11.Subjects who have been previously advised of abnormalities or concerns regarding liver function parameters (such as gamma-GTP, AST, or ALT) during a health checkup or similar medical examination. 12.Subjects with using health foods, supplements, and medications that reduce fatigue. 13.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 14.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition. 15.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 16.Subjects who have difficulty in recording compliance with various survey forms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, physical measurements, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
MIS Co.,Ltd. Clinical Development Department
Outcome results
None listed