UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the immune function in healthy Japanese subjects

Acronym

Effects of consumption of the test food on the immune function in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on the immune function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the immune function in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the food containing lactic acid bacteria on the immune function in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured values and amount of change from screening (before consumption; Scr) in each of the following items at four weeks after consumption (4w): scoring of immunological vigor, T lymphocyte age, 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 score of B cells, the score of NK cells, and the number of CD8⁺CD28⁺T cells

Key secondary outcomes

The measured values and amount of change from Scr of interferon (IFN)-alfa, the activity of plasmacytoid dendritic cells (pDC), and immunoglobulin G of SARS-Cov-2, and the maximum duration of the days with common cold symptoms during the intervention period

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Capsule containing lactic acid bacteria
Administration: Take one capsule with water 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 food: Placebp capsule
Administration: Take one capsule with water 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

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 have received vaccination for SARS-Cov-2 at least two times

7. Subjects who are judged as eligible to participate in the study by the physician

8. 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. Subjects who 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 have autoimmune disease

5. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

6. Subjects who cannot stop taking the food containing lactic acid bacteria (such as natto, yogurt, and fermented food) or lactic fermenting beverage during the test period

7. Subjects who currently taking medications (including herbal medicines) and supplements

8. Subjects who are taking immunosuppressants such as steroids

9. Subjects who are allergic to medicines and/or the test beverage related products

10. Subjects who have pollen allergy or perennial allergic rhinitis

11. Subjects who are pregnant, breast-feeding, and planning to become pregnant

12. Subjects who suffer from COVID-19

13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

14. Subjects who are judged as ineligible to participate in the study by the physician

15. Subjects who have received vaccination for influenza within the last three months before the agreement to participate in this trial

16. Subjects who plan to receive vaccination for SARS-Cov-2 during the test period

Target sample size

20

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

KITII Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2022

Year

02

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

02

Month

16

Day

Date of IRB

2022

Year

02

Month

16

Day

Anticipated trial start date

2022

Year

02

Month

22

Day

Last follow-up date

2022

Year

06

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

02

Month

24

Day

Last modified on

2023

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053609