UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059465 |
|---|---|
| Receipt number | R000068009 |
| Scientific Title | A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Healthy Adults Working in Commercial Facilities |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/10/20 12:00:46 |
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Basic information
Public title
A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Healthy Adults Working in Commercial Facilities
Acronym
A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Commercial Facility Workers
Scientific Title
A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Healthy Adults Working in Commercial Facilities
Scientific Title:Acronym
Drinkingrut
Region
| Japan |
Condition
Condition
Health
Classification by specialty
| Clinical immunology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This crossover study involving healthy adults working in commercial facilities will compare changes in salivary IgA levels, effects on oral and intestinal microbiota, and perceived health benefits, as measured by questionnaire surveys, between periods of yogurt consumption and non-consumption. The yogurt samples fermented with lactic acid bacteria strains OLL1073R-1 and OLS3059 will be evaluated. This study verifies the effects of yogurt consumption on immune function and holds significance for contributing to infection prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Meiji Probio Yogurt R-1 Drink Type
Interventions/Control_2
Non-consumption period
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 999 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Sakurai |
Organization
Chiba University
Division name
Center for Preventive medical Sciences
Zip code
263-8522
Address
1-33 Yayoi-cho, Inage, Chiba, Japan
TEL
0432903920
sakuraik@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Koshizaka |
Organization
Chiba University
Division name
Center for Preventive medical Sciences
Zip code
2630023
Address
1-33 Yayoi-cho, Inage, Chiba, Japan
TEL
08046565544
Homepage URL
overslope@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
043-222-7171
inohana-rinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
ららぽーと柏の葉および関連施設
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068009
