UMIN-ICDS Clinical Trial

Public title

Examination of the effects of research food intake on immune function.

Acronym

Examination of the effects of research food intake on immune function.

Scientific Title

Examination of the effects of research food intake on immune function.

Scientific Title:Acronym

Examination of the effects of research food intake on immune function.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of research food intake for 12 consecutive weeks on immune function using placebo as a control

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Physical condition, Immune function

Key secondary outcomes

QOL questionnaire, Stress questionnaire, Blood immune markers, Body temperature

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

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake research food for 12 consecutive weeks

Interventions/Control_2

Intake placebo for 12 consecutive weeks

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Healthy males and females from 20 years old and under 65 years old

Key exclusion criteria

(1)Subjects who did not have cold (like) symptoms during Jan, 2019 - Apr, 2020
(2) Subjects who regularly use health food containing involvement ingredients at least 3 times a week.
(3) Subjects who can not restrict drinking the specified beverage during test period.
(4) Subjects who constantly use medications affecting the immune system.
(5)Subjects who constantly use supplements and/or functional foods affecting the immune system.
(6) Subjects who intend to get vaccinated within 4 weeks or done.
(7) Subjects who have symptoms that affect the performance of the test.
(8) Subjects who get treatment affecting the test results.
(9) Night and day shift worker or manual laborer
(10) Subjects who habitually do intense exercise such as marathon.
(11) Subjects who cannot carry out inspection procedure as prescribed
(12) Subjects who are judged as having serious diseases
(13) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
(14) Subjects having possibilities for emerging allergy related to the study
(15) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(16) Subjects who intend to become pregnant or lactating
(17) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(18) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(19) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

124

Name of lead principal investigator

1st name	Makoto
Middle name
Last name	Ozeki

Organization

Taiyo Kagaku Co., Ltd.

Division name

Nutrition division

Zip code

510-0844

Address

1-3, Takara-cho, Yokkaichi-shi, Mie

TEL

070-6470-0183

Email

mozeki@taiyokagaku.co.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

162-0822

Address

Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

03-5657-4983

Homepage URL

Email

nakagawa768@eps.co.jp

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

Taiyo Kagaku Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

saito876@eps.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

04

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

124

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

2020

Year

11

Month

26

Day

Date of IRB

2020

Year

11

Month

26

Day

Anticipated trial start date

2020

Year

12

Month

01

Day

Last follow-up date

2021

Year

04

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

30

Day

Last modified on

2022

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048620