UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

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 test food for eight weeks on immune function in healthy Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Major immune related marker

Key secondary outcomes

<Important secondary outcomes>
Physical condition questionnaire

<Other secondary outcomes>
Secondary immune related markers and quality of life (QOL) index

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: Eight weeks
The test food
Administration: Four capsules/pack/day

Interventions/Control_2

Duration: Eight weeks
Placebo
Administration: Four capsules/pack/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. Male and female

3. Individuals aged 20 or more

4. Healthy individuals

5. Individuals who have had common cold-like symptoms at least once during the same period as this study's intervention in the past two years

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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, anemia, or any other chronic diseases

4. Individuals who have autoimmune disease

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

6. Individuals who are taking or using medications (including herbal medicines) or supplements, particularly those who regularly use warfarin, rhinitis medicines, or antihistamines

7. Individuals who use immunosuppressants such as steroid

8. Individuals who are allergic to medicines or foods

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

10. Individuals who have pollen allergy or perennial allergic rhinitis

11. Individuals who are smokers or have quit smoking within the last year before the agreement to participate in this study

12. Individuals who drink alcoholic beverages excessively

13. Individuals who are on a diet

14. Individuals who engage in intense exercise

15. Individuals who have an irregular lifestyle due to shift work or other reasons

16. Individuals who have received vaccinations for the purpose of preventing infectious diseases within the three months before the agreement to participate in this study, or who are scheduled to receive vaccinations during this study

17. 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 in another study during this study

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

Target sample size

180

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

Euglena 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

12

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

Open public recruiting

Date of protocol fixation

2024

Year

10

Month

30

Day

Date of IRB

2024

Year

10

Month

30

Day

Anticipated trial start date

2024

Year

11

Month

12

Day

Last follow-up date

2025

Year

04

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

<Statistical details>
The names and definitions of the subgroup analysis sets are given below. All subgroups will be constructed based on the per protocol set (PPS).

Major immune related marker, secondary immune related markers, and physical condition questionnaire: >= mean / < mean at each time point
Major immune related marker, secondary immune related markers, and physical condition questionnaire: >= median / < median at each time point
QOL index: >= mean / < mean
QOL index: >= median / < median
Male / female
Age: >= mean / < mean at the time of obtaining the consent
Age: >= median / < median at the time of obtaining the consent
Age is >= 40 / < 40 at the time of obtaining the consent

Registered date

2024

Year

11

Month

12

Day

Last modified on

2024

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064130