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: an open-label trial

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 on the immune function in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Scoring of immunological vigor

Key secondary outcomes

1. T lymphocyte age, the rate of CD3⁺T cells, the number of CD3⁺T cells, the score of CD3⁺T cells, the rate of CD4⁺T cells, the number of CD4⁺T cells, the rate of CD8⁺T cells, the number of CD8⁺T cells, the rate of naive T cells (CD4⁺), the number of naive T cells (CD4⁺), the score of naive T cells (CD4⁺), the rate of memory T cells (CD4⁺), the number of memory T cells (CD4⁺), the score of memory T cells (CD4⁺), CD8⁺CD28⁺ T cells, the rate of B (CD20⁺) cells, the number of B cells (CD20⁺), the score of B cells (CD20⁺), the rate of NK cells (CD56⁺CD16^-), the rate of NK cells (CD56⁺CD16⁺), the rate of NK cells (CD56^-CD16⁺), the number of NK cells, the score of NK cells, the ratio of CD4⁺/CD8⁺T cells, the score of ratio of CD4⁺/CD8⁺T cells, the ratio of naive T cells to memory T cells, the score of ratio of naive T cells to memory T cells, and immunological grade

2. An original questionnaire measured by Likert scale (1. "I have a tendency to constipation", 2. "I am concerned about stool smell", 3. "I am concerned about body odor", 4. "I am concerned about halitosis", 5. "My skin is dry", 6. "I am concerned about skin condition", 7. "My waist is tight", 8. "My body is heavy", 9. "I feel stress", and 10. "I am easily tired")

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Food containing lactic acid EF-2001 strain (1.3 x 10¹² cells)
Administration: Take one packet with water two times a day each after breakfast and dinner

* 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

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

30

years-old

<=

Age-upper limit

50

years-old

>

Gender

Female

Key inclusion criteria

1. Japanese

2. Women

3. Subjects aged 30 or more and less than 50

4. Healthy subjects

5. Subjects who easily feel tired and catch colds

6. Subjects whose scoring of immunological vigor are between 14 and 20 at screening (before consumption; Scr)

7. Subjects whose scoring of immunological vigor are relatively low 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 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," or "Foods with Functional Claims" in daily

5. Subjects who 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 suffer from COVID-19

9. 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

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

11. Subjects whose working hours are irregular

12. Subjects whose ifestyles are irregular (such as dietary habits, exercise habits, and sleeping habits)

13. Subjects who have autoimmune disease

14. Subjects who are taking immunosuppressants such as steroids

15. Subjects who have perennial allergic rhinitis

16. Subjects who are currently undergoing treatment of insomnia or sleep disorder

17. Subjects who are smokers

18. Subjects who have lactose intolerance

19. Subjects who have a medical history or history of present illness of immunodeficiency, severe bowel disease, valvular heart disease, or hepatic cirrhosis

20. Subjects who are undergoing central venous catheterization

Target sample size

10

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

MEDI CUBE 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

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

11

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

05

Month

25

Day

Date of IRB

2022

Year

05

Month

25

Day

Anticipated trial start date

2022

Year

06

Month

02

Day

Last follow-up date

2022

Year

09

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

05

Month

31

Day

Last modified on

2023

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054586