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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046578
Receipt No. 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 2022/01/07

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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
Email 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
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
Email 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 Preinitiation
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 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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