UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050569 |
|---|---|
| Receipt number | R000057600 |
| Scientific Title | The Effect of a Test Diet on Immune Function in Healthy Men - Single-Arm, Open-Label Trial |
| Date of disclosure of the study information | 2024/04/27 |
| Last modified on | 2024/02/16 09:14:18 |
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Basic information
Public title
The Effect of a Test Diet on Immune Function in Healthy Men - Single-Arm, Open-Label Trial
Acronym
The Effect of a Test Diet on Immune Function in Healthy Men.
Scientific Title
The Effect of a Test Diet on Immune Function in Healthy Men - Single-Arm, Open-Label Trial
Scientific Title:Acronym
The Effect of a Test Diet on Immune Function in Healthy Men.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a test diet, taken continuously for four weeks, on immune function in men over 20 years of age and less than 50 years of age.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immunological parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take sixteen tablets a day, once or twice daily.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. Aged over 20 years of age and less than 50 years of age.
2. Male adults.
3. BMI over 18.5 kg/m^2 and less than 30.0kg/m^2.
4. Have contracted an upper respiratory infection more than once a year.
5. Who can use smartphones or PC to record a daily diary.
6. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.
Key exclusion criteria
1. Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable.
2. Receive diet or exercise therapy under medical supervision.
3. Have serious illnesses or a history of serious illnesses.
4. Have immune disorders such as atopic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis.
5. Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacteria more than three times a week.
6. Have been taking foods or dietary supplements with functional health claims that affect the outcome of the study more than three times per week.
7. Be vaccinated against influenza viruses or SARS-CoV-2 within one month before the first study visit, or have the plan to be vaccinated during the study.
8. Have allergies to drugs or foods.
9. Workers on night shifts or with irregular work schedules.
10. Who plans for significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits.
11. Alcohol drinking over an average of 40g/day per week.
12. Who plans to travel abroad during the study period.
13. Have above 200 mL blood donation within one month before the start period of the study, or have above 400 mL blood donation within three months before the start period of the study.
14. Those who have participated in other clinical trials within one month before enrolling in the study, those who are currently participating in other clinical trials, and those who plan to participate in other clinical trials after enrolling in the study.
15. Who are unsuitable for the study, as determined by the investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Takada |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Business Design Department
Zip code
5418564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL
06-6263-2924
y.takada@ono.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
Daiwaginza Bld.3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2024 | Year | 04 | Month | 27 | 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
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057600
| Research Plan | |
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| Registered date | File name |
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