UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043136 |
|---|---|
| Receipt number | R000049247 |
| Scientific Title | Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial |
| Date of disclosure of the study information | 2021/01/26 |
| Last modified on | 2022/02/15 13:41:44 |
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Basic information
Public title
Effects of consumption of the test food on the immune function
Acronym
Effects of consumption of the test food on the immune function
Scientific Title
Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on the immune function
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of eight-week consumption of the test food on the immune function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The cumulative number of days with common cold symptoms (*) during the intervention period per subject
* The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain
Key secondary outcomes
1. The maximum duration of the days with common cold symptoms (*) during the intervention period per subject
2. The cumulative number of days with common cold symptoms (*) during the intervention period per group
3. The percentage of subjects who have infected with the influenza virus during the intervention period
4. The measured values and changes from screening of the following items at four and eight weeks after consumption: physical component summary (PCS), mental component summary (MCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, mental health, scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+T cells to CD8+T cells, the score of naive T cells, the score of ratio of naive T cells to memory T cells, the score of B cells, the score of NK cells, the number of T cells, the ratio of CD4+T cells to CD8+T cells, the number of naive T cells, the ratio of naive T cells to memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells, NK cell activity and salivary IgA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: Brolico
Administration: Take nine tablets per day in the morning
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: Eight weeks
Test food: Placebo
Administration: Take nine tablets per day in the morning
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who catch colds easily
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects who have low scoring of immunological vigor at screening
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take ""Foods for Specified Health Uses,"" ""Foods with Functional Claims,"" or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines, the test food related products, or pollen
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who are smokers
10. Subjects who have a past or current medical history of respiratory disease
11. Subjects who have an autoimmune disease
12. Subjects who have a history of salivary glands treatment
13. Subjects who are taking immunosuppressants such as steroids
14. Subjects who have received vaccination for infectious diseases such as influenza within a year
15. Subjects who have an exercise habit with 4.0 METs or more (such as vigorous running)
16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
30
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 Building, 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
Imagine Global Care Corporation
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 Building, 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
| 2021 | Year | 01 | Month | 26 | 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
32
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 | 01 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049247
