Health
Conditions
Interventions
Meiji Probio Yogurt R-1 Drink Type
Non-consumption period
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults who are not infected with any infectious disease at the time of registration 2) Individuals who, after receiving adequate explanation regarding participation in this study, provided written informed consent based on full understanding and of their own free will 3) Males or females aged 18 years or older at the time of consent acquisition 4) Individuals deemed by the principal investigator or sub-investigator to be able to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1) Individuals with serious illnesses (including significant laboratory abnormalities) that the principal investigator or sub-investigator determines may affect the interpretation of data or safety, or prevent safe conduct of protocol assessments 2) Individuals who participated in another clinical trial within 30 days prior to obtaining consent 3) Individuals with a history of hypersensitivity to yogurt or lactose intolerance 4) Individuals with a history of severe drug hypersensitivity or allergic reactions, such as anaphylaxis 5) Individuals unable to comply with the study's essential requirements or procedures 6) Pregnant women, breastfeeding women, or individuals who may be pregnant or planning to become pregnant 7) Individuals deemed unsuitable by the principal investigator or sub-investigator 8) Individuals consuming Meiji Probio Yogurt R-1 four or more days per week 9) Individuals using systemic steroids, antibiotics, or probiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the change in IgA levels before and after the R-1 yogurt intake period with the change in IgA levels before and after the non-intake period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the percentage of change in IgA levels before and after the R-1 yogurt intake period with the percentage of change in IgA levels before and after the non-intake period. Compare the change amounts and percentages of change before and after R-1 yogurt intake with the change amounts and percentages of change during the non-intake period for the following items: 1) Gut microbiota 2) Oral microbiota 3) Questionnaires Athens Insomnia Scale (AIS) Sleep survey (Sleep duration, etc.) Presence of cold symptoms (nasal discharge, cough, sneezing, fever, fatigue, joint pain, nasal congestion, sore throat, chills) S-WHO-5-J Visual Analog Scale (VAS) Whole-body fatigue (Worst feeling: completely exhausted, unable to do anything...Best feeling: no fatigue at all) Restfulness upon waking (No feeling of rest at all...Fully rested) Mental stress (Maximum stress imaginable...No stress felt) Health status (Worst health imaginable...Best health imaginable) Considering differences in observation periods, intergroup comparisons for the above items will be performed separately for the early and late periods between the R-1 yogurt intake group and the non-intake group. Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactMasaya Koshizaka
Chiba University Center for Preventive medical Sciences
Outcome results
None listed