UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045839 |
|---|---|
| Receipt number | R000052320 |
| Scientific Title | The effects of yogurt intake on immune function for healthy adults |
| Date of disclosure of the study information | 2021/10/23 |
| Last modified on | 2023/05/25 17:36:14 |
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Basic information
Public title
The effects of yogurt intake on immune function for healthy adults
Acronym
The effects of yogurt intake on immune function for healthy adults
Scientific Title
The effects of yogurt intake on immune function for healthy adults
Scientific Title:Acronym
The effects of yogurt intake on immune function for healthy adults
Region
| Japan |
Condition
Condition
N/A (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether yogurt intake activates dendritic cells.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity of dendritic cells
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
Oral intake of test food once a day for 4 weeks.
Interventions/Control_2
Oral intake of placebo food once a day for 4 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese healthy males and females of 35 to 59 years age
2. Subjects with fatigue (POMS2 item 26 is 1 or higher and SF-36v2 item 9, "Did you feel tired?", is 3 or lower
3. Subjects giving written informed consent
Key exclusion criteria
1. Subjects with sever systemic diseases affecting the results of this study
2. Subjects who have chronic illness and take medication everyday
3. Subjects who have been drug dependency
4. Subjects who have been taking food containing lactic acid bacteria (e.g. yogurt), health food (e.g. food for specified health use, nutritional functional food, and supplements) regularly for the past month or more
5. Subjects who drink regularly more than 40 g of alcohol (1,000 mL of beer) per day
6. Subjects who can't stop drinking for 2 days before the days of screening and checkup
7. Subjects with no fatigue at all (SF-36v2 item 9, "Were you full of energy?", is 1)
8. Subjects with smoking habits
9. Subjects who have visited a medical facility for the treatment of pollinosis in the past year, or who will probably take prescription medication for the treatment of pollinosis during the study period
10. Subjects who received digestive surgical procedures
11. Subjects who probably have oral or dental problems with bleeding during the study period
12. Subjects who have the plan to receive the influenza vaccine during the study period
13. Subjects with hemoglobin level of 12 g/dl or lower for males and 11 g/dl or lower for females according to the blood test in the screening
14. Subjects who are positive for infectious in the screening
15. Subjects in pregnancy or in nursing
16. Subjects who prone to diarrhea when consuming dairy products
17. Subjects with food allergies
18. Subjects who have participated in other study in the past one month prior to screening, or plan to participate during the test period
19. Subjects who are judged as unsuitable for this study by the investigator for other reasons
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
81-42-632-5842
hiroshi.kano@meiji.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
81-3-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
81-3-5641-4133
niho-jimucho@well-sleep.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 | 10 | Month | 23 | 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
110
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 | 08 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 18 | 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 | 10 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052320
