UMIN-CTR Clinical Trial

Public title

Examination of the effect of continuous intake of test foods on immune function.

Acronym

Examination of the effect of continuous intake of test foods on immune function.

Scientific Title

Examination of the effect of continuous intake of test foods on immune function.

Scientific Title:Acronym

Examination of the effect of continuous intake of test foods on immune function.

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of continuous intake of test foods for 8 weeks on immune system markers in male and female aged between 40 and 70 years old.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Inflammatory markers, body temperature measurement, questionnaire

Key secondary outcomes

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

Take 2 tablets of test foods daily for 8 weeks.

Interventions/Control_2

Take 2 tablets of placebo foods daily for 8 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

40

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Aged 40 to under 70 at the time of informed consent.
2. Male and female
3. Those who are susceptible to upper respiratory tract infections in winter every year.
4. Those who can input electronic diary with smartphone / PC
5. Those who can obtain written consent

Key exclusion criteria

1.Those who are currently under continuous treatment with drugs. (Abortive use is acceptable.)
2. Those who are on a diet or exercise therapy under the supervision of a doctor.
3. Those who have a current or history of serious illness.
4. Those with atopic dermatitis, allergic rhinitis (seasonal / perennial), bronchial asthma, chronic bronchitis
5. Those who are currently using quasi-drugs, foods for specified health uses, health foods and supplements. Those who can quit during the test period after obtaining consent are allowed to participate.
6. Those who regularly intake foods containing lactic acid bacteria or bifidobacterium.
7. Those who have been vaccinated with influenza vaccine within 1 month before the pre-intake test, or who will be vaccinated during the test period
8. Those who have a past and current medical history of drug or food allergy.
9. Those who work in shifts, such as those who work night shifts
10. Those who consume alcohol excessively (alcohol equivalent 60g or more / day)
11. Those who have excessive smoking habits (21 or more cigarettes / day)
12. Those who are planning to travel abroad during the test period
13. Those who wish to become pregnant, breastfeeding, or during the test period
14. Those who have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the test period
15. Those who are judged by the investigator or coordinator to be unsuitable for participating in this study

Target sample size

40

Name of lead principal investigator

1st name	Tomokazu
Middle name
Last name	Ishizuka

Organization

SBI ALApromo Co.,Ltd.

Division name

Product Development Department

Zip code

106-6017

Address

1-6-1 Roppongi Minato-ku Tokyo

TEL

03-6229-0092

Email

toishizu@sbigroup.co.jp

Name of contact person

1st name	Hirokuni
Middle name
Last name	Kayama

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL

Email

h-kayama@imeqrd.co.jp

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name

Organization

SBI ALApromo Co.,Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.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

2020

Year

11

Month

23

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

Completed

Date of protocol fixation

2020

Year

11

Month

09

Day

Date of IRB

2020

Year

11

Month

10

Day

Anticipated trial start date

2020

Year

11

Month

24

Day

Last follow-up date

2021

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

13

Day

Last modified on

2021

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048448