UMIN-CTR Clinical Trial

Public title

A verification study of the immunostimulatory effects

Acronym

A verification study of the immunostimulatory effects

Scientific Title

A verification study of the immunostimulatory effects: an open-label trial

Scientific Title:Acronym

A verification study of the immunostimulatory effects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the immunostimulatory effects of consumption of the test food

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The plasmacytoid dendritic cell (pDC) activity at eight weeks after consumption (8w)

2. Interleukin-10 (IL-10), interferon-gamma (IFN-gamma), tumor necrosis factor-alfa (TNF-alfa), and natural killer (NK) cell activity at 8w

3. Immunoglobulin A (IgA), acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid and water content in the stool at 8w

4. Secretary IgA (s-IgA) in the saliva and the volume of saliva at 8w

5. Scoring of immunological vigor, T lymphocyte age, the number of T cells, the ratio of CD4⁺/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, and the number of CD8⁺CD28⁺T cells at 8w

Key secondary outcomes

1. The cumulative number of days and the maximum duration of the days with common cold symptoms*

2. The stool amount questionnaire at 8w

3. Each score of the MOS Short-Form 36-Item Health. Survey (SF-36) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health} at 8w

4. The defecation frequency, the number of defecation days, the amount of defecation, stool shape, stool smell, and exhilarating feeling of defecation during the period of the test food consumption

* The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain

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

Take the test food for eight weeks

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects who feel tired on a daily basis

6. Subjects whose salivary IgA is relatively low

Key exclusion criteria

Subjects

1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. who usually take "Foods for Specified Health Uses," or "Foods with Functional Claims" / particularly who use dietary fiber ingredients (such as fructo oligosaccharide, indigestible dextrin, and polydextrose) or dietary supplements for the immunostimulation

5. who are currently taking medications (including herbal medicines or immunosuppressants such as steroid) and supplements

6. who are allergic to medicines and/or the test food related products or have seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, asthma, atopic dermatitis, allergic conjunctivitis, food allergy, or metal allergy

7. who are pregnant, lactating, or planning to become pregnant during this trial

8. who have received preventive vaccination for influenza within the last three months

9. who have undergone or plan to undergo dental or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} between one month prior to the agreement to participate and completion of this trial

10. who have bleeding tooth or oral problems such as stomatitis

11. who work in shifts or physical labor such as transportation of heavy objects

12. who suffer from COVID-19

13. 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. who are judged as ineligible to participate in this study by the physician

Target sample size

15

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

NIHON SHOKUHIN KAKO 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

2024

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

16

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

10

Month

19

Day

Date of IRB

2022

Year

10

Month

19

Day

Anticipated trial start date

2022

Year

10

Month

31

Day

Last follow-up date

2023

Year

02

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

10

Month

31

Day

Last modified on

2023

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056204