Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese men and women age more than 30 less than 75 2. Subjects who have chronic fatigue or difficulty in recovery from fatigue. 3. Subjects who have weakened immune systems (who had relatively low in NK cells activity or immunity score from the results of a screening test) 4. Subjects who agree to participate in the current study and provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects under medication for chronic diseases (especially related to cancer, hepatic, renal, cardiac, gastrointestinal or mental disorders, diabetes, dyslipidemia and/or hypertension 2. Subjects who have severe cerebral, vascular, cardiac, hepatic, renal and / or gastric disorders 3. Subjects who are suspectedly infected with an acute infection such as influenza, etc. 4. Subjects with ongoing treatment of autoimmune disorder, chronic inflammatory and / or allergic disease 5. Subjects who were vaccinated in the last 12 weeks or intend to be vaccinated during the trial period. 6. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries. 7. Pre- or post-menopausal women having obvious changes in physical condition 8. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. 9. Subjects who have a serious anemia. 10. Subjects who have a history of allergy or sensitivity to medicine and / or food (especially green onions, mushrooms, and gelatin). 11. Subjects who regularly take medicine (antibiotics, immunosuppressant, antirheumatic, anti-inflammatory, antihistamine, antiallergic, lactobacillus preparation), traditional Chinese medicine, health food, supplements (mushrooms, seaweed, nucleic acid, yeast and/or lactobacillus) which may affect immunity function. 12. Heavy smokers and alcohol addicts, or having irregular lifestyle. 13. Subjects who donated 400ml whole blood within the past 12 weeks or donated plasma or platelets within the last 4 weeks prior to supplementation. 14. Pregnant or lactating women, or women expect to be pregnant during the clinical trial 15. Subjects who participated in other clinical trials within the last one month prior to the clinical trial 16. Any other medical reasons judged by the responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural Killer cell activity, immune score (lymphocyte subset analysis by flow cytometry method) | — |
Secondary
| Measure | Time frame |
|---|---|
| Leukocyte counts, differential leukocyte count, serum MCP-1, IgG, IgM, salivary IgA, common cold questionnaire(CCQ), VAS (stress, fatigue, etc.), questionnaire about change in physical condition | — |
Countries
Japan
Contacts
Hokkaido Information University Health Information Science Center