UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044808 |
|---|---|
| Receipt number | R000051174 |
| 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 | 2021/07/20 |
| Last modified on | 2022/06/23 09:26:57 |
* 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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Fermented milk drink
1 bottle/day for 43 days
Interventions/Control_2
Unfermented milk drink
1 bottle/day for 43 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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. Males aged 30 to 49 years when informed consent.
2. Subjects who work within office buildings.
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
1. Subjects who tested positive for SARS-CoV-2 before the screening, who tested positive for hepatitis B virus, hepatitis C virus, syphilis and human immunodeficiency virus in the screening.
2. Subjects who themselves or family living together tested positive for SARS-CoV-2, or have a fever of 37.5 degrees or higher within the last four weeks.
3. Subjects who are planning to receive the COVID-19 vaccine during the trial.
4. Subjects who have diseases which are difficult to differentiate from upper respiratory infection by themselves.
5. Subjects who have abdominal symptoms by ingesting dairy products.
6. Subjects who constantly intake fermented dairy products and/or lactic acid bacteria preparation.
7. Subjects who constantly use food for specified health use, functional foods, supplements, and/or healthy food having a possibility of affecting the result of this trial.
8. Subjects who have previous and/or current medical history of serious disease.
9. Subjects who with heavy use of alcohol, and heavy smoking.
10. Subjects who have extremely irregular dining habits.
11. Subjects who are participating the other clinical tests, who participated the other clinical tests within 4-weeks prior to the current study.
12. Subjects who have previous medical history of drug and/or food, allergy, especially for milk.
13. Subjects who donated over 200mL blood and/or blood components within the last one month.
14. Subjects who donated over 400mL blood and/or blood components within the last three month.
15. Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
16. Others who have been determined ineligible by principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Doctor
Zip code
101-0047
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL
03-5297-5548
s.s@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL
03-5297-3112
Homepage URL
m.n@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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo
Tel
03-5297-5548
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
| 2021 | Year | 07 | 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
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
