Healthy adult
Conditions
Interventions
Intake of Natto for 4 consecutive weeks
Intake of placebo for 4 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects from 18 to 64 years of age (2) Subjects who agree with the participation in this study after understanding the aim of the study and contents (3) Subjects who can intake test supplement (Natto or steam soybeans) everyday (4) Selection of subjects in order of the lower rate of secretion of s-IgA in saliva on preliminary examination
Exclusion criteria
Exclusion criteria: (1) Subjects who were unaware of influenza, cold symptom, or flu-like symptoms between November in 2020 to November in 2022 (2) Subjects who have caught COVID-19, cold symptom, or flu-like symptoms within the past month prior to the pre-test date (3) Subjects who are currently taking medication (4) Subjects who have allergic diseases (5) Subjects who had vaccination by one month before the pre-test date (6) Subjects who have the trouble of teeth or oral cavity with bleeding (7) Subjects who have got treatment teeth or oral cavity within the past month prior to the pre-test date (8) Subjects who intake food, healthy food or medicine including lactic acid bacterium more than 1 day per week (9) Subjects who intake Natto 4 days or more per week or intake Natto except test supply during this study (10) Subjects who are engaged in day / night shift work or midnight work (11) Subjects who have possibilities for emerging allergy related to the study or a food allergy (12) Subjects whose total blood collection during this study period will exceed 1200 mL for males and 800 mL for females. (13) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary (14) Subjects who have the disease requiring regular medication or a history of serious diseases for which medication was required (15) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range (16) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey (17) Subjects who are participating in the other study at the start of this study (18) Subjects who plan to become pregnant or breastfeed during the study period (19) Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MFI of pDC activity(HLA-DR, CD86) in the peripheral blood | — |
Secondary
| Measure | Time frame |
|---|---|
| MFI of pDC activity(CD-40, CD80) in the peripheral blood s-IgA in saliva record of flu-like symptoms | — |
Countries
Japan
Contacts
Public ContactSaki Miyayama
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section 1
Outcome results
None listed