UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053690 |
|---|---|
| Receipt number | R000061269 |
| Scientific Title | A study for the effect of test food on biological response of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial. |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/07/09 14:16:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for the effect of test food on infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Acronym
A study for the effect of test food on infectious diseases
Scientific Title
A study for the effect of test food on biological response of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Scientific Title:Acronym
A study for the effect of test food on infectious diseases
Region
| Asia(except Japan) |
Condition
Condition
None (Healthy adult)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test food on biological response of infectious diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of test food on biological response of infectious diseases on biological response of blood cells.
Key secondary outcomes
1. General wellbeing of participants evaluated by questionnaires.
2. Severity of infectious disease like illness
3. Expression of anti-infectious factors
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
Daily one bottle of study product is administered to participant for consecutive 4 weeks.
Interventions/Control_2
Daily one bottle of placebo is administered to participant for consecutive 4 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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Signed and dated informed consent form provided, after willingness of participants confirmed
2)Willingness to comply with all study procedures for the period of the study
3)Healthy adult (20 < Age < 30)
4)Persons who have COVID vaccine at least two times and more than 2 weeks have passed after last vaccination
5)Persons who are not currently infected with SARS-CoV2, and if they had been infected, at least 4 weeks have passed since recovery.
6)No underlying acute and/or chronic sickness from respiratory disease and/or gastrointestinal disease at enrolment.
Key exclusion criteria
1)Unable to provide signed and dated informed consent form
2)Unable to comply with all the study procedures
3)Allergic to milk and/or soy (contained within the study products)
4)Regularly using steroid drugs (immune suppressive drugs)
5)Any persons deemed inappropriate as participants by the principal investigators of this study
6)Those currently participating in other clinical trials (participants) or those who are planning to participate in other clinical trials during the study period
7)Women who are pregnant, or intend to get pregnant during the study period, or breastfeeding mothers
8)Cannot stop drinking alcohol for two days before sampling blood
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | |
| Last name | Truong Tuyet |
Organization
National Institute of Nutrition
Division name
National Institute of Nutrition
Zip code
100000
Address
48B Tang Bat Ho, Hanoi, Vietnam
TEL
+842439713137
truongmai1976@gmail.com
Public contact
Name of contact person
| 1st name | Hajjime |
| Middle name | |
| Last name | Nozawa |
Organization
Kirin Holdings Co., Ltd.
Division name
Institute of health science
Zip code
251-8555
Address
Shonan iPark, 26-1,2- Muraoka-Higashi, Fujisawa, Kanagawa, Japan
TEL
+818022893085
Homepage URL
h-nozawa@kirin.co.jp
Sponsor or person
Institute
National Institute of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings 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
The Ethical Committee of National Institute of Nutrition, Ministry of Health, Vietnam
Address
48B Tang Bat Ho, Hanoi, Vietnam
Tel
+84 24 3971 3137
truongtuyetmai@dinhduong.org.vn
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
Hai Phong Medical University
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | 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
110
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 | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061269
