UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046351 |
|---|---|
| Receipt number | R000052868 |
| Scientific Title | A Study on the Effect of Food Containing Microorganism on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2021/12/10 18:24:27 |
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Basic information
Public title
A Study on the Effect of Food Containing Microorganism on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study on the Effect of Food Containing Microorganism on Immune Function
Scientific Title
A Study on the Effect of Food Containing Microorganism on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Microorganism on Immune Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing microorganism on immune function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of dendritic cells in peripheral blood
Key secondary outcomes
Physical condition questionnaire
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
Foods containing microorganism, 8 weeks consumption
Interventions/Control_2
Foods not containing microorganism, 8 weeks consumption
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females aged 20 to 64 years-old
2)Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
Subjects(who)
1)contract, are under treatment for or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, thyroid gland disease, adrenal gland disease and/or metabolic disease)
2)have a chronic disease and regularly use medications
3)have a history and/or a surgical history of digestive disease affecting digestion and absorption
4)are judged as unsuitable for the current study by blood tests in screening test
5)have had no subjective symptoms of upper respiratory tract infection in the last two winters
6)contract pollinosis or allergic rhinitis and use drugs
7)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions
8)take foods containing lactic acid bacteria or bifidobacteria at least twice a week
9)have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent
10)are smokers
11)have a habit of strenuous exercise such as running or soccer
12)can't stop drinking from a day before each measurement
13)have declared allergic reaction to ingredients of test foods
14)are under treatment for or have a history of drug addiction and/or alcoholism
15)are shiftworker and/or midnight-shift worker
16)are planning to go abroad, such as on an overseas trip
17)are pregnant or breastfeed or planning to become pregnant
18)have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within two weeks prior to the screening test
19)have donated over 200 mL of blood and/or blood components within the last four weeks prior to the screening test or over 400 mL of blood and/or blood components within the last three months prior to the screening test
20)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study
21)are judged as unsuitable for the current study by the investigator for other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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 Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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 | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052868
