UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052918 |
|---|---|
| Receipt number | R000060380 |
| Scientific Title | A verification study of the improving effect of consumption of the test food on the immune function: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2024/04/19 09:17:27 |
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Basic information
Public title
A verification study of the improving effect of consumption of the test food on the immune function
Acronym
A verification study of the improving effect of consumption of the test food on the immune function
Scientific Title
A verification study of the improving effect of consumption of the test food on the immune function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the improving effect of consumption of the test food on the immune function
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the immune function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The cumulative number of onset days with common cold-like symptoms during the intervention period per participant
Key secondary outcomes
1. Immune-related biomarkers (dynamics of immune cells, antibodies, and cytokines)
2. The maximum duration of the onset days with common cold-like symptoms during the intervention period per participant
3. The cumulative number and the maximum duration of the onset days with each symptom (whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, nasal congestion, throat pain, cough, joint pain, and muscle pain) during the intervention period per participants
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test food
Interventions/Control_2
Duration: Four weeks
Placebo
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged between 40 and 64
4. Healthy individuals
5. Individuals who are aware of catching colds easily and who caught colds in the last year
6. Individuals who feel fatigue on a daily basis
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products
7. take the test food or similar foods
8. are pregnant, lactating, or planning to become pregnant during this study
9. have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during this study
10. have received vaccination for influenza or COVID-19 within the last three months before agreeing to participate
11. have pollen allergy such as Japanese red-cedar or cypress, or perennial allergic rhinitis
12. take foods which may affect the immune function such as mushroom, lactic acid bacteria, or Korean ginseng
13. have chronic fatigue syndrome, diagnosed a doctor based on persistent fatigue lasting for six months.
14. are smokers or have quit smoking within the last year before the agreement to participate
15. plan to have surgery within two weeks after the last consumption
16. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
17. have irregular sleeping time or habit due to work such as a late-night shift
18. have irregular lifestyles (such as diet, exercise, and sleep)
19. are undergoing medical treatment for menopausal syndrome
20. work in physical labor such as transportation of heavy objects
21. are judged as ineligible to participate by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 27 | 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
22
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 | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060380
