UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056714 |
|---|---|
| Receipt number | R000064823 |
| Scientific Title | Effects of continuous yogurt consumption on immune function and physical condition |
| Date of disclosure of the study information | 2025/01/19 |
| Last modified on | 2025/01/14 18:26:15 |
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Basic information
Public title
Effects of continuous yogurt consumption on immune function and physical condition
Acronym
Effects of continuous yogurt consumption on immune function and physical condition
Scientific Title
Effects of continuous yogurt consumption on immune function and physical condition
Scientific Title:Acronym
Effects of continuous yogurt consumption on immune function and physical condition
Region
| Japan |
Condition
Condition
N/A (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous yogurt consumption on immune function and physical condition in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration and secretion rate of salivary s-IgA
Key secondary outcomes
Salivary secretion rate, cold-like symptoms, dendritic cell activity, cytokine production in PBMC, and NK cell activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (yogurt, 112 g) once daily for 8 weeks.
Interventions/Control_2
Oral intake of the placebo food (acidified milk, 112 g) once daily for 8 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese male and female aged 20-64 years at the time of consent acquisition.
2) Subjects who consider themselves prone to catching colds.
3) Subjects who provide written informed consent.
Key exclusion criteria
1) Subjects who have/had serious diseases affecting this study.
2) Subjects with chronic diseases who use medication regularly.
3) Subjects regularly consuming yogurt, lactic acid bacteria beverages, health foods, or supplements for 1 month or more before the screening test.
4) Subjects unable to refrain from consuming yogurt, lactic acid bacteria beverages, health foods, or supplements after consent.
5) Subjects with an average daily alcohol intake exceeding 40 g.
6) Subjects unable to abstain from alcohol for 1 day before the examination.
7) Subjects with smoking habits.
8) Subjects with a history of hay fever between January and April in the past 3 years or potential for hay fever during this study.
9) Subjects with gastrointestinal diseases or past gastrointestinal surgeries affecting digestion/absorption (excluding appendicitis).
10) Subjects with persistent oral problems involving bleeding.
11) Subjects planning to receive any vaccinations from 1 month before the screening test to the 12-week examination.
12) Subjects participating in other research within 4 weeks before consent or planning to participate in other research after consent.
13) Subjects who are engaged in day/night shift work.
14) Subjects who are pregnant, breastfeeding, or intend to become pregnant during this study.
15) Subjects prone to diarrhea after consuming dairy.
16) Subjects with milk allergies.
17) Subjects who donated component blood or 200 mL whole blood within 1 month before this study.
18) Males who donated 400 mL of whole blood within 3 months before this study.
19) Females who donated 400 mL of whole blood within 4 months before this study.
20) Males whose total blood draw volume, including the planned volume for this study, exceeds 1,200 mL within 12 months before this study.
21) Females whose total blood draw volume, including the planned volume for this study, exceeds 800 mL within 12 months before this study.
22) Subjects deemed unsuitable by the investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 19 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 25 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064823
