UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049778 |
|---|---|
| Receipt number | R000056693 |
| Scientific Title | The effect of the milk drink on immunity index for healthy adults: A double-blind, randomized, controlled parallel group study |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2023/11/24 09:30:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of the milk drink on immunity index for healthy adults
Acronym
The effect of the milk drink on immunity index for healthy adults
Scientific Title
The effect of the milk drink on immunity index for healthy adults: A double-blind, randomized, controlled parallel group study
Scientific Title:Acronym
The effect of the milk drink on immunity index for healthy adults: A double-blind, randomized, controlled parallel group study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a milk drink on immunity index of healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunity index
Key secondary outcomes
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
Fermented milk drink
1 bottle/day for 42 days
Interventions/Control_2
Unfermented milk drink
1 bottle/day for 42 days
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and Females aged 20 to 59 years when informed consent.
2. Subjects who work as company employees or part-time workers within office buildings at least once a week.
3. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria
subjects --
1. proved positive for COVID-19 before the pre-test, hepatitis B, hepatitis C, syphilis, or acquired immune deficiency syndrome at the pre-test,
2. with positive for COVID-19 within the past four weeks before the final examination,
3. planning to be vaccinated against COVID-19 and influenza, during this test,
4. having any symptoms (e.g., chronic rhinitis, asthma), with a difficulty in distinguishing from upper respiratory tract infection,
5. with any difficulty in giving up taking pollinosis medicines (except eye and nasal drops) during this test,
6. with abdominal symptoms by ingesting dairy products,
7. who constantly intake fermented dairy products and/or lactic acid bacteria preparation (e.g., yogurt, lactic fermenting beverage),
8. who take steadily (over twice a week) in affecting health-specific/functional/supplementary/health foods,
9. who take steadily (over twice a week) in affecting medicines (e.g., antibiotic/gut/laxative regulation),
10. with excessive alcohol intake,
11. with heavy heavy smoking (more than 21per day),
12. with extremely irregular eating habits / life rhythm (e.g., midnight work),
13. who have previous and/or current medical history of serious disease,
14. with pregnant, possibly pregnant, or lactating,
15. who have previous medical history of drug and/or food, allergy, especially for milk,
16. being under other clinical tests, or partook in those within the past four weeks before this test, or will join those after the consent,
17. who donated over 0.2L blood and/or blood components within the last one month.
18. who donated over his 0.4L whole blood within the last three month,
19. who donated over her 0.4L whole blood within the last four month,
20. being collected in total of his blood (1.2 L) within the past 12 months and in this test,
21. being collected in total of her blood (0.8 L) within the past 12 months and in this test,
22. Others who have been determined ineligible by principal investigator --.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Naito |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo 186-0012, Japan
TEL
042-577-8960
tomoaki-naito@yakult.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
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
Yakult Honsha 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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 20 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently measuring immune-related indicators in blood plasma
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 06 | Month | 09 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056693
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
