Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese male and female aged 20 years or older and younger than 65 years at the time of the informed consent. 2.Subject who is relatively high TMD score of POMS2 shortened version. 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. 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 has or had a history of mental illness (depression) or sleep disturbance. 6.Subject who is on a night-shift worker. 7.Subject whose lifestyle is extremely irregular. 8.Subject who has an unbalanced diet. 9.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person. 10.Subject who uses drugs that may affect immune function (antibiotics, immunosuppressants, anti-inflammatory drugs, antirheumatic drugs, antihistamines, antiallergic drugs, lactic acid bacteria preparations, etc.) 11.Subject who uses health foods that affect immune function (such as yogurt products with functionality (immunity activation)), supplements, and pharmaceuticals 12.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13.Subject who performs intense exercises such as jogging, marathon and soccer 14.Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 15.Subject who is currently pregnant or lactating, or planning to get pregnant. 16.Subject who can't keep the daily records. 17.Subject who is judged to be inappropriate as test subject from clinical laboratory test values and measurement values at the time of SCR. 18.Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wisconsin upper respiratory symptom survey-21 (WURSS-21) | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS2 shortened version, peripheral blood image, NK cell activity, immunity evaluation, each item scores, flow cytometry analysis data, analysis data, secretory IgA | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed