UMIN-CTR Clinical Trial

Public title

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

Acronym

The verifying efficacy and safety of test food consumption on immune function in healthy Japanese subjects

Scientific Title

The verifying efficacy and safety of test food consumption on immune function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

The verifying efficacy and safety of test food consumption on 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 efficacy and safety of test food consumption on immune function and inflammatory markers 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

1. The cumulative number of days with common cold symptoms (*) during the intervention period per subject

* 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

Key secondary outcomes

1. The maximum duration of the days with common cold symptoms (*) during the intervention period per subject

2. The measured values and amount of change from before consumption (Scr) in each of the following items at eight weeks after consumption (8w):
immunity test {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}, the amount of change of inflammatory markers {interleukin (IL)-6, IL-1 beta, tumor necrosis factor-alfa, high sensitivity C-reactive protein, the number of leukocyte, leukocyte image (the ratio and number of neutrophil, lymphocyte, monocyte, eosinophil, and basophil)} and neutrophil/lymphocyte ratio

3. The measured values and amount of change from Scr in each of the following items at 8w and 12 weeks after consumption (12w): Circulating markers of liver function {asparate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyltranspeptidase (gamma-GT)}, body weight, body mass index, body fat percentage, and muscle mass

* 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

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: A
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: B
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_3

Duration: 12 weeks
Test food: Placebo
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

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

6. Subjects whose scoring of immunological vigor is relatively low

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, gastroesophageal reflux disease, hormone sensitive diseases, iron deficiency, 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 currently taking medicines (include herbal medicines) and supplements

6. Subjects who are allergic to medications and/or the test-food-related products

7. Subjects who suffer from COVID-19

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

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 smokers

11. Subjects who have autoimmune disease

12. Subjects who are taking immunosuppressants such as steroids

13. Subjects who have received vaccination for influenza within the last three months

14. Subjects who have surgery within the last two weeks

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

Target sample size

90

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

Theravalues,Inc

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

2021

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

99

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

2021

Year

11

Month

17

Day

Date of IRB

2021

Year

11

Month

17

Day

Anticipated trial start date

2021

Year

11

Month

24

Day

Last follow-up date

2022

Year

05

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

11

Month

24

Day

Last modified on

2023

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052685