UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036610 |
|---|---|
| Receipt number | R000041710 |
| Scientific Title | A verification study of enhancement of the immune system with ingestion of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2019/04/26 |
| Last modified on | 2021/06/17 10:16:09 |
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Basic information
Public title
A verification study of enhancement of the immune system
Acronym
A verification study of enhancement of the immune system
Scientific Title
A verification study of enhancement of the immune system with ingestion of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study of enhancement of the immune system with ingestion of the test food
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 the test food on enhancement of the immune system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Scoring of immunological vigor
* Assess the measured value at screening (before consumption) and at 4 weeks after consumption or calculate the amount of change.
Key secondary outcomes
1. T lymphocyte age
2. Number of T cells
3. CD4+T cells/CD8+ T cells ratio
4. Number of naive T cells
5. Naive T cells/memory T cells ratio
6. Number of B cells
7. Number of NK cells
8. Number of CD8+CD28+T cells
9. Subjective symptoms (The Likert scale method)
*1-8 Assess the measured value at screening (before consumption) and at 4 weeks after consumption or calculate the amount of change.
*9 Assess the measured value at screening (before consumption) and at 4 weeks after consumption.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Test food: Marrowgen
Administration: Take 4 capsules of the test food with water after breakfast, lunch, and dinner
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 4 weeks
Test food: Placebo
Administration: Take 4 capsules of the test food with water after breakfast, lunch, and dinner
* 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. Healthy Japanese adult subjects
2. Subjects who are experiencing daily fatigue and easy to get sick
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who have relatively low scoring of immunological vigor at screening (before consumption)
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 diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function 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 and/or the test food related products
7. Subjects who are pregnant, lactation, or 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 enroll in anther clinical trial during trial period
9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
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
Kokezen Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara 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
info@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)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
| 2019 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041710
