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: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A verification study of the immunostimulatory effects

Region

Japan

Condition

Healthy Japanese

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.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The cumulative number of onset days with common cold-like symptoms* during the intervention period per participant

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

Key secondary outcomes

1. The maximum duration of the days with common cold-like symptoms* during the intervention period per participant

2. The measured value of the total immunoglobulin A (IgA) in the stool at four weeks after consumption (4w)

3. The measured values of scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit and lower limit), percentage of CD3⁺T cells, number of CD3⁺T cells, scoring of number of CD3⁺T cells, percentage of CD4⁺T cells, number of CD4⁺T cells, percentage of CD8⁺T cells, number of CD8⁺T cells, CD4⁺T cells / CD8⁺T cells ratio, scoring of CD4⁺T cells / CD8⁺T cells ratio, percentage of naive T cells, number of naive T cells, scoring of number of naive T cells, percentage of memory T cells, number of memory T cells, naive T cells / memory T cells ratio, scoring of naive T cells / memory T cells ratio, percentage of CD56⁺16^-natural killer (NK) cells, percentage of CD56⁺16⁺NK cells, number of NK cells, scoring of number of NK cells, percentage of B cells, number of B cells, scoring of number of B cells, percentage of CD8⁺CD28⁺T cells, number of CD8⁺CD28⁺T cells, and scoring of number of CD8⁺CD28⁺T cells at 4w

4. The measured values of vitality, appetite, skin condition measured by visual analog scale (VAS) at 4w

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food

Interventions/Control_2

Duration: Four weeks
Placebo food

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 individuals

5. Individuals who noticed any of the following symptoms in the last one month: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, nasal congestion, throat pain, cough, joint pain, and muscle pain

Key exclusion criteria

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

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

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

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking medications (including herbal medicines) and supplements

6. Individuals who are allergic to medicines and/or the test food related products (particularly salmon or gelatin)

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

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study

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

10. Individuals who have received vaccination for infectious diseases such as influenza within the last three months

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

ICHIMARU PHARCOS 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 Bldg., 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

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

12

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

2023

Year

11

Month

15

Day

Date of IRB

2023

Year

11

Month

15

Day

Anticipated trial start date

2023

Year

11

Month

27

Day

Last follow-up date

2024

Year

02

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

27

Day

Last modified on

2024

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060381