UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042449 |
|---|---|
| Receipt number | R000048448 |
| Scientific Title | Examination of the effect of continuous intake of test foods on immune function. |
| Date of disclosure of the study information | 2020/11/23 |
| Last modified on | 2024/05/17 12:57:47 |
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Basic information
Public title
Examination of the effect of continuous intake of test foods on immune function.
Acronym
Examination of the effect of continuous intake of test foods on immune function.
Scientific Title
Examination of the effect of continuous intake of test foods on immune function.
Scientific Title:Acronym
Examination of the effect of continuous intake of test foods on immune function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous intake of test foods for 8 weeks on immune system markers in male and female aged between 40 and 70 years old.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory markers, body temperature measurement, questionnaire
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
Take 2 tablets of test foods daily for 8 weeks.
Interventions/Control_2
Take 2 tablets of placebo foods 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 40 to under 70 at the time of informed consent.
2. Male and female
3. Those who are susceptible to upper respiratory tract infections in winter every year.
4. Those who can input electronic diary with smartphone / PC
5. Those who can obtain written consent
Key exclusion criteria
1.Those who are currently under continuous treatment with drugs. (Abortive use is acceptable.)
2. Those who are on a diet or exercise therapy under the supervision of a doctor.
3. Those who have a current or history of serious illness.
4. Those with atopic dermatitis, allergic rhinitis (seasonal / perennial), bronchial asthma, chronic bronchitis
5. Those who are currently using quasi-drugs, foods for specified health uses, health foods and supplements. Those who can quit during the test period after obtaining consent are allowed to participate.
6. Those who regularly intake foods containing lactic acid bacteria or bifidobacterium.
7. Those who have been vaccinated with influenza vaccine within 1 month before the pre-intake test, or who will be vaccinated during the test period
8. Those who have a past and current medical history of drug or food allergy.
9. Those who work in shifts, such as those who work night shifts
10. Those who consume alcohol excessively (alcohol equivalent 60g or more / day)
11. Those who have excessive smoking habits (21 or more cigarettes / day)
12. Those who are planning to travel abroad during the test period
13. Those who wish to become pregnant, breastfeeding, or during the test period
14. Those who have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the test period
15. Those who are judged by the investigator or coordinator to be unsuitable for participating in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Ishizuka |
Organization
SBI ALApromo Co.,Ltd.
Division name
Product Development Department
Zip code
106-6017
Address
1-6-1 Roppongi Minato-ku Tokyo
TEL
03-6229-0092
toishizu@sbigroup.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
SBI ALApromo Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
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
jimukyoku@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
| 2020 | Year | 11 | 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
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
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048448
