UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046578 |
|---|---|
| Receipt number | R000053138 |
| Scientific Title | A study to confirm the effect of test food on improving human immune function. -Open Study- |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2022/03/30 15:32:34 |
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Basic information
Public title
A study to confirm the effect of test food on improving human immune function.
-Open Study-
Acronym
A study to confirm the effect of test food on improving human immune function.
Scientific Title
A study to confirm the effect of test food on improving human immune function.
-Open Study-
Scientific Title:Acronym
A study to confirm the effect of test food on improving human immune function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of test food on improving human immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pDC activity
Key secondary outcomes
Salivary sIgA (concentration, secretion rate, secretion amount)
CD56 / CD16 (NK cells)
Physical condition Questionnaire
QOL questionnaire
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 test food once a day, 2 capsules, for 4 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females from 20 to 64 years of age at the time of consent to participate in this study.
2. Subjects who know they are prone to catching a cold.
3. Subjects who do not plan to inoculate vaccines such as COVID-19 or influenza virus during the research period.
4. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases.
2. Subjects who have chronic diseases and take medication on a daily basis.
3. Subjects who regularly use medicines (e.g., Antihistamine, antiallergics, Nasal spray and Common cold medicines) or food for specified health use or Food with functional claims or health food that may affect immune function.
4. Subjects who are not able to stop taking foods rich in lactic acid bacteria and bifidobacterial, or lactic acid bacteria preparations or supplements.
5. Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day).
6. Subjects who can't stop drinking from 2 days before each test.
7. Subjects who have food allergy.
8. Subjects engaged in day and night shift work or Physical labor such as transporting heavy objects.
9. Subjects with digestive diseases affecting digestion and absorption and Subjects with a history of digestive surgery. (excluding appendicitis)
10. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
11. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests.
12. Subjects who have a history or current condition of drug or alcohol dependence.
13. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate.
14. Subjects who plan to travel abroad, including overseas travel, during this research period.
15. Subjects who has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components.
16. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clini
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 | 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
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TEIJIN LIMITED
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, Gumma
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
| 2022 | Year | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053138
