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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043706
Receipt No. R000049904
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 2021/03/22
Last modified on 2021/09/27

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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 four-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 measured values of scoring of immunological vigor at four weeks after consumption (4w)
Key secondary outcomes 1. The measured values of scoring of immunological vigor at two weeks after consumption (2w)
2. The amount of change of scoring of immunological vigor between screening (before consumption; Scr) and 2w, or 4w
3. The measured values of following items at 2w and 4w: T lymphocyte age (upper limit), 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, salivary IgA, and the items of MOS Short-Form 36-Item Health Survey {SF-36; physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health}
4. The amount of changes of following items between Scr and 2w, or 4w:
T lymphocyte age (upper limit), 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, salivary IgA, and the items of SF-36 (PCS, MCS, RCS, physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health)
5. The number of subjects who were scored in each of the following items of immunological vigor at 2w and 4w: immunological grade, 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, and the score of NK cells

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: Four weeks
Test beverage: Fermented soy milk with lactic acid bacteria
Administration: Take one test beverage per day at any time during the day

* 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: Four weeks
Test beverage: Placebo drink
Administration: Take one test beverage per day at any time during the day

* 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. Men or women
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 Scr
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 beverage 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 another clinical trial during trial period
9. Subjects who are diagnosed with pollen allergy
10. Subjects who are smokers
11. Subjects who have a past or current medical history of respiratory disease
12. Subjects who have an autoimmune disease
13. Subjects who have a history of salivary glands treatment
14. Subjects who are taking immunosuppressants such as steroids
15. Subjects who have received vaccination for infectious diseases such as influenza within three month
16. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size 60

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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Asahi Soft Drinks 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 Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email 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 03 Month 22 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 66
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 03 Month 17 Day
Date of IRB
2021 Year 03 Month 17 Day
Anticipated trial start date
2021 Year 03 Month 23 Day
Last follow-up date
2021 Year 07 Month 24 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 03 Month 22 Day
Last modified on
2021 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049904

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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