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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042294
Receipt No. R000048285
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 2020/11/01
Last modified on 2021/06/21

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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 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The measured value of scoring of immunological vigor at four weeks after consumption (4w)
Key secondary outcomes 1. The measured values of following items at 4w:
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, and salivary IgA, 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

2. The amount of changes of following items between screening (before consumption) and 4w:
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, and salivary IgA, PCS, MCS, RCS, physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health

3. The cumulative number of days with common cold symptoms (nasal discharge, blocked nose, throat pain, cough, whole body malaise, joint pain, and chilliness) during the intervention period per group

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: four weeks
Test food: Capsule containing 100 mg of lactic acid bacteria
Administration: Take two capsules once a day between meals.

*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 food: Capsule containing 10 mg of lactic acid bacteria
Administration: Take two capsules once a day between meals.

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3 Duration: four weeks
Test food: Placebo
Administration: Take two capsules once a day between meals.

*If you forget to take the test food, take it as soon as you remember within the day.
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 prone to catching colds
3. Subjects who are judged as eligible to participate in the study by the physician
4. 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, short bowel syndrome, 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 take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
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, or pollen
7. Subjects who are pregnant, lactating, 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 participate another trial during this trial
9. Subjects who are smokers
10. Subjects who have had a medical treatment for their salivary gland or intestine
11. Subjects who have received vaccination for infectious diseases such as influenza within a year
12. Subjects who are allergic to dairy-related product
13. 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 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 Combi 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
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
2020 Year 11 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 33
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
2020 Year 10 Month 27 Day
Date of IRB
2020 Year 10 Month 27 Day
Anticipated trial start date
2020 Year 11 Month 02 Day
Last follow-up date
2021 Year 03 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 30 Day
Last modified on
2021 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048285

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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